tag:blogger.com,1999:blog-88762691571580317442024-03-18T23:23:14.640-04:00PK/PDA blog with random discussions on drug development.AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.comBlogger34125tag:blogger.com,1999:blog-8876269157158031744.post-44899020936727776702017-12-22T10:22:00.004-05:002017-12-22T10:22:59.380-05:00FDA Commissioner Scott Gottlieb on Quantitative Methods in Drug Development<div dir="ltr" style="text-align: left;" trbidi="on">
Watch Gottlieb's speech where he outlines the steps FDA is taking to modernize how clinical information to make decisions about the safety/effectiveness of new drugs is being collected and evaluated. In particular he focuses on two aspects -<br />
<ul>
<li>Adaptive and seamless clinical trial approaches</li>
<li>Better use of more advanced computing tools, and more sophisticated statistical and computational methodologies, as part of the drug development and the drug review process</li>
</ul>
<div>
<br /></div>
<div class="separator" style="clear: both; text-align: center;">
<iframe width="320" height="266" class="YOUTUBE-iframe-video" data-thumbnail-src="https://i.ytimg.com/vi/JJbWZ1OWDU8/0.jpg" src="https://www.youtube.com/embed/JJbWZ1OWDU8?feature=player_embedded" frameborder="0" allowfullscreen></iframe></div>
<div>
<br /></div>
<div>
Here is the <a href="https://www.fda.gov/NewsEvents/Speeches/ucm575400.htm" target="_blank">transcript</a> and a key message.</div>
<blockquote class="tr_bq">
<i><span style="color: #666666;"><b>"In silico clinical trials use computer models and simulations to develop and evaluate devices and drugs. Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials. FDA’s efforts in modeling and simulation are enabled through multiple collaborations with external parties that provide additional expertise and infrastructure to advance the development of these state-of-the-art technologies.</b></span></i></blockquote>
<blockquote class="tr_bq">
<i><b><span style="color: #cc0000;">FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development."</span></b></i></blockquote>
</div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-26466311463052186322017-11-11T12:15:00.001-05:002017-11-11T12:15:00.690-05:00My philosophy for a happy life | Sam Berns | TEDxMidAtlantic<iframe allowfullscreen="" frameborder="0" height="270" src="https://www.youtube.com/embed/36m1o-tM05g" width="480"></iframe>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-38142027758430120582017-11-11T11:55:00.002-05:002017-11-11T12:16:00.576-05:00We need better drugs--now<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
A very nice talk by Francis Collins.<br />
<div class="separator" style="clear: both; text-align: center;">
<br /></div>
<iframe allowfullscreen="" class="YOUTUBE-iframe-video" data-thumbnail-src="https://i.ytimg.com/vi/2_0aEezKvBE/0.jpg" frameborder="0" height="266" src="https://www.youtube.com/embed/2_0aEezKvBE?feature=player_embedded" width="320"></iframe><br />
<br />
<br /></div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-41916156065906410642015-12-20T09:35:00.001-05:002015-12-20T09:47:45.444-05:00Benefits of using modeling and simulation in drug development<div dir="ltr" style="text-align: left;" trbidi="on">
Check out this video...a very nice illustration of how clinical pharmacologists use PKPD to influence decision making during drug development.<br />
<br />
<iframe allowfullscreen="" frameborder="0" height="270" src="https://www.youtube.com/embed/o2ntCRCgpUM?list=PL4C70CE64C0E14B30" width="480"></iframe></div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-3674723153574008352015-12-13T21:41:00.003-05:002015-12-13T21:41:52.223-05:00Cancer Drug Costs<div dir="ltr" style="text-align: left;" trbidi="on">
<br /> Interesting <a href="http://www.asco.org/practice-research/cancer-care-america-2015/focus-cost" target="_blank">read</a> on a review of cancer drug costs by ASCO. <br />
<img alt="" class="media-image attr__typeof__foaf:Image img__fid__27006 img__view_mode__media_original attr__format__media_original" height="617" src="http://www.asco.org/sites/www.asco.org/files/tab4.jpg" width="640" /><br />
<br />
</div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-79790228417789261692015-12-13T20:35:00.001-05:002015-12-13T20:38:26.725-05:00Cost of Developing a New Drug<div dir="ltr" style="text-align: left;" trbidi="on">
<iframe allowfullscreen="" frameborder="0" height="270" src="https://www.youtube.com/embed/EcGJm5FrMPA" width="480"></iframe></div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-59598117734943346992015-12-13T20:14:00.002-05:002015-12-13T20:14:31.348-05:00Oncology and Dose Finding<div dir="ltr" style="text-align: left;" trbidi="on">
Earlier this year, US FDA and AACR <span id="DeltaPlaceHolderMain"> cosponsored a public workshop titled “<b>Dose-finding of Small Molecule Oncology Drugs</b>.” There were several interesting presentations and recommendations on how we can optimize the dose and dosing schedule during development. As in other therapeutic </span><span id="DeltaPlaceHolderMain"><span id="DeltaPlaceHolderMain">. </span>areas, dose finding studies are usually not conducted during oncology drug development and the dose for phase 2/3 studies is typically based on MTD and PKPD data from limited patients in the dose escalation trial.</span><br />
<span id="DeltaPlaceHolderMain"><br /></span>
<span id="DeltaPlaceHolderMain"></span><br />
<span id="DeltaPlaceHolderMain">The goal was to promote a movement
away from conventional dose escalation trial design and move toward
innovative designs that can incorporate key clinical, pharmacologic,
pharmacometric data, and when appropriate, non-clinical information to
guide dose selection. </span><br />
<span id="DeltaPlaceHolderMain"><br /></span>
<span id="DeltaPlaceHolderMain">Check out the agenda, </span><span id="DeltaPlaceHolderMain">slides and recorded presentation at <a href="http://www.aacr.org/AdvocacyPolicy/GovernmentAffairs/Pages/dose-finding-of-small-molecule-oncology-drugs.aspxhttp://www.aacr.org/AdvocacyPolicy/GovernmentAffairs/Pages/dose-finding-of-small-molecule-oncology-drugs.aspx" target="_blank">Dose-finding of Small Molecule Oncology Drugs</a></span><br />
<br />
<br /></div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-57919123494163745002013-12-27T00:19:00.001-05:002014-03-29T14:50:46.272-04:00Bioavailability/Bioequivalence Regulatory Guidance Documents- Link Updated<div dir="ltr" style="text-align: left;" trbidi="on">
After a long time, I have gone back and updated the guidance documents in my original post "<a href="http://pk-pd.blogspot.com/2008/10/bioavailabilitybioequivalence.html">Bioavailability/Bioequivalence Guidelines</a>". There have been quite a number of changes to the documents, some have been revised and some have been replaced with new guidance documents. Let me know if I am missing something or if you find any broken links!.<br />
<br /></div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-53131459037045981262013-12-25T14:15:00.003-05:002013-12-25T14:15:49.122-05:00Pharmacometric Tutorials<div dir="ltr" style="text-align: left;" trbidi="on">
Some additional tutorials for learning population PK modeling and simulation have been published by <i>CPT: Pharmacometrics & Systems Pharmacology</i> and are available for free under open access. <br />
<br />
<ol style="text-align: left;">
<li><a href="http://www.nature.com/psp/journal/v1/n9/full/psp20124a.html">Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development</a> </li>
<li><a href="http://www.nature.com/psp/journal/v2/n4/full/psp201314a.html">Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development—Part 2: Introduction to Pharmacokinetic Modeling Methods</a> </li>
<li><a href="http://www.nature.com/psp/journal/v2/n5/full/psp201318a.html">A Time to Event Tutorial for Pharmacometricians</a> </li>
<li><a href="http://www.nature.com/psp/journal/v2/n7/full/psp201326a.html">Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance</a></li>
</ol>
<a href="http://metruminstitute.org/index.html">Metrum Institute</a> recently announced that their youtube videos on PK/PD training courses will be freely available to the public. This is an excellent news and kudos to them for making it available free of cost. Something to bookmark and check out if you are interested to learn modeling and cant afford the training courses,<br />
<blockquote class="tr_bq">
<pre>Video recordings and lecture notes from six semester-long courses (MI205,
MI210, MI212, MI250, MI255, and MI260) can be found on the Metrum Institute
YouTube channel (<a href="http://www.youtube.com/metruminst" rel="nofollow">http://www.youtube.com/metruminst</a>). Topics include: R
programming for pharmacometrics, introductory and intermediate topics in
population PK modeling, modeling continuous and categorical population PKPD
data, Bayesian PKPD modeling, and Bayesian model-based meta-analysis.</pre>
</blockquote>
Happy Holidays!</div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-4901989616651558292013-06-15T17:48:00.000-04:002013-06-15T17:48:10.682-04:00The Role of Clinical Pharmacology in the Trial of Conrad MurrayOne of the key highlights of ASCPT 2013 was the presentation by Dr. Shafer on "<span class="Normal"><a href="http://www.ascpt.org/2013AnnualMeeting/ASCPT2013AnnualMeetingPresentations/FeaturedSpeakerVideo/tabid/14337/Default.aspx">The Role of Clinical Pharmacology in the Trial of Conrad Murray</a>". If you have not seen his presentation, I would strongly encourage you to do so. Dr. Shafer does an excellent job in explaining the concepts of PK, PD, simulations and pharmacometrics in simple words to the jurors. </span>This is <span class="Normal">a practical example of the utility of PK/PD modeling & simulation. So, sit back and enjoy the presentation.</span><br />
<span class="Normal"><br /></span>
<span class="Normal"><br /></span>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com3tag:blogger.com,1999:blog-8876269157158031744.post-31394174138050805052009-06-16T18:55:00.003-04:002009-06-30T21:13:42.847-04:00Clinical Pharmacokinetic Studies in Drug DevelopmentI wanted to compile a list of various PK studies conducted during the course of drug development. Several studies are conducted in the early phase of clinical development to understand the pharmacokinetics (PK) of a new drug in healthy human volunteers and/or patients. The objective of such PK studies is to evaluate the absorption, distribution, metabolism and excretion (ADME) of a new drug in humans.<br /><br />Information gathered during these studies include PK parameters such as area under the curve (AUC, exposure), Cmax (maximum concentration) , Tmax (Time to Cmax), half life, clearance, volume of distribution, bioavailability, steady state plasma concentrations, accumulation ratio, linear or nonlinear PK, time dependent PK (auto-induction), plasma protein binding, metabolite identity and their PK.<br /><br />Here goes the list.<br /><blockquote>1. Single Ascending Dose (SAD)<br />2. Multiple Ascending Dose (MAD)<br />3. Food Effect Studies<br />4. ADME Mass Balance Studies<br />5. Absolute/Relative Bioavailability<br />6. Thorough QTc Study<br />7. Drug Interaction Studies - Enzyme Inhibition/Induction<br />8. Effect of Age and Gender<br />9. Special Population - Hepatic Impairment<br />10. Special Populaiton - Renal Impairment<br />11. Impact of Genetic Polymorphisms of Drug Metabolizing Enzymes<br /></blockquote>I will be blogging on each of these topics in the next few weeks. I am quite keen to know how modeling & simulation approaches have been used in early clinical PK studies. Feel free to share your thoughts/comments, any unusual experiences in the conduct of these studies.AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com3tag:blogger.com,1999:blog-8876269157158031744.post-19861332976871536522009-06-09T20:33:00.007-04:002013-12-26T21:35:47.975-05:00Phase 0 Microdosing/Microtracing in Phase 1 StudiesStephen Dueker, PhD, President/CEO of <a href="http://www.vitaleascience.com/">Vitalea Science</a> recently commented on my previous post on <a href="http://pk-pd.blogspot.com/2008/04/human-microdosing-studies-phase-zero.html">Microdosing Studies</a>. I thought of posting his comments and his email content pertaining to Microdosing/Microtracer studies in Phase 1 as a fresh post. Steve has also generously provided his recent presentation at ASMS meeting to be posted on this blog.<br />
<br />
--------------------<br />
<br />
All the methods and procedures for bioAMS were developed at Lawrence Livermore National Lab (LLNL) and the latest technology, the BioMICADAS developed by ETH/Zwitzerland and Vitalea Science (who has the original developer of bioAMS). It is important that people know the history of bioAMS and that it was the results of 15 years of intense research at Livermore in genotoxicity, nutrition, chemical interactions, pharmacology, and enviornmental studies. Other companies simply transferred some of the methods from LLNL.<br />
<embed allowfullscreen="true" height="400" src="http://embedit.in/N9aK8GLAPp.swf" type="application/x-shockwave-flash" width="466"></embed><br />
<br />
What needs to be understood is that <span style="color: #990000; font-weight: bold;">AMS is much more than Phase 0</span>. As a CRO, many companies are doing microdosing as a means of "understanding the physiochemistry" of their compounds. The predictive PK topic is not the primary objective of microdosing, as PK can be solved later in formulation development. Microdosing is early ADME and understanding of the human metabolism. <span style="color: #660000; font-weight: bold;">Receptor binding, tissue biopsies, cell loading, routes of elimination, protein binding, biotransformatio</span>n, etc...can all be ascertained in a microdosing study. This indeed is what the specificity of a tracer and the sensitivity of AMS uncover.<br />
<br />
<br />
There is a growing body of evidence that microdosing is predictive of macrodose PK, but again, that is not our (Vitalea's) principal focus nor would it be if I were a drug developer. Rank ordering multiple candidates is an interesting idea to supplant animal testing and I am surprised it is not used more, but generally developers are pretty attached to "their" candidate - thus we see scientists simply want to learn more so that they can have more efficient later Phase trials with fewer surprises. Analyses that we have been asked to do in microdosing proper are<br />
<br />
<ul>
<li>Prodrug metabolism</li>
<li>Cellular penetration (Cell Loading)</li>
<li>Confirm absence or presence of unwanted metabolites</li>
<li>Potential for protein binding</li>
<li>Balance (does the drug come out).</li>
</ul>
<br />
I think this last point is important, as one will never see deep reservoirs with macrodose ADME clearly. We have seen drug material leak out for weeks in some cases for a 6 hr half-life drug. None of it is parent drug. When these drugs become daily doses, these reservoirs accumulate and essentially lead to self-drugging by the drug and its metabolites. The impact this could have on idiosyncratic adverse events and safety in general, is real, and should be known in advance. Macrodoses swamp the system and tell little of the PhysioKemistry that is alway active, but not perceptible.<br />
<br />
<br />
It is everyone’s desire to find a panacea to the complexity of drug development. Perhaps that is unrealistic. I see a new age where companies spend more time on their molecules, understanding and viewing metabolism and PhysioKemistry not as a nuisance, but as a tool to understand the drug fully (or class of compounds) avoid the potential for later stage surprises, and streamline IND phase testing once it commences.<br />
<br />
<br />
The marginal relevance of animal testing is clear despite the objections of the preclin crowd (no disrespect here) - how can sub-therapeutical human data not be valuable in myriad ways. That is the question to be asked? Not is microdosing predictive of macrodose PK. Pharmacokinetic prediction is great, but metabolism impacts safety in unexpected ways. Microdosing or Phase 1 ADME using microtracers is a very good option to make better decisions.The hot topic is now <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079266.pdf">MIST guidance</a>, not so much Phase 0. AMS finds all metabolites without method development or internal standards.<br />
<br />
<br />
Just coming back from ASMS, it is clear that MIST guidance has put a good deal of "concern" into the pharma business about how to address this important safety issue of steady state metabolite exposure. While my head is still trying to sort through the myriad configurations of hybridized MS instrumentation, the common theme running through all the very excellent MS talks was that radioanalysis is the most straightforward and absolute means of addressing MIST. Non-traditional radioanalysis, using AMS, expedites the entire endeavor.<br />
<br />
It would appear that the field has come full circle - nothing is so powerful as a near 0 background analysis (14C) for unequivocal metabolite discovery, After discovery, one would then need to enlist the many sophisticated and quite impressive MS techniques for metaID when odd metabolites are revealed.<br />
<br />
I do not see PK as the most important issue. Safety and Efficacy are the issue, and PhysioKemistry provides a view into processes that impact the later. This is a complex business. I am not sure if "more shots on goal" by emphasizing speed over understanding is the way to go.<br />
<br />
Steve<br />
<embed allowfullscreen="true" height="400" src="http://embedit.in/Ae54pEkrMa.swf" type="application/x-shockwave-flash" width="466"></embed><br />
---- -----------<br />
<br />
Feel free to discuss and share your experience with Microdosing/AMS/Microtracer studies.AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com7tag:blogger.com,1999:blog-8876269157158031744.post-15196342579464584402009-04-30T08:11:00.002-04:002009-04-30T08:24:06.237-04:00Clinical PharmacologyIts been a while since I had posted anything here. While I have been busy juggling between being a dad to a month old boy and trying to finish thesis work, I try to find time to recap and update myself on PK/PD. Here is a link with lots of presentations on various concepts of clinical pharmacology by authors of the book "<a href="http://www.amazon.com/Principles-Clinical-Pharmacology-Arthur-Atkinson/dp/0120660601">Principles of Clinical Pharmacology"</a>. <br /><br />http://www.cc.nih.gov/training/training/principles/schedule.html<br /><br />Have fun learning!AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com5tag:blogger.com,1999:blog-8876269157158031744.post-5927356050492546382008-12-15T15:49:00.011-05:002009-06-07T18:16:00.676-04:00PKPD Regulatory GuidancesAfter a short hiatus, I am back and hope to continue posting frequently. Ok. If you are planning to work in the industry or already dealing with population PK studies, then you may want to read the guidances pertaining to PK/PD. These guidances provide recommendations on study design, data analysis and report writing which can be very helpful in your work.<br /><br />Listed below are some guidances where PopPK or PK/PD studies are recommended by FDA or EMEA.<br /><br />Population Pharmacokinetics [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072137.pdf">PDF</a>] - This document provides recommendation on the study design and execution, model development & validation and reporting the results of a PopPK analysis. Some examples of how the results are used in drug labeling are also provided. However, the document doesnt delve deep into the qualification of softwares used for such analysis. Neither does it talk about any preferred softwares like NONMEM or SAS or Splus.<br /><br />Guideline on Reporting the Results of Population Pharmacokinetic Analysis [<a href="http://www.emea.europa.eu/pdfs/human/ewp/18599006enfin.pdf">PDF</a>] - This EMEA guideline provides in detail the information required in a report submitted for their review. I like this document over FDA's guidance especially because they spell out exactly the kind of information one needs to report in terms of NONMEM lingo eg, choice of analysis (parametric or non parametric or bayesian), estimation methods (FO vs FOCE vs FOCE INTER), GOF plots like DV vs PRED, DV vs IPRED (with line of identity and trend line (:>)) and so forth.<br /><p>Other guidances that recommend PK/PD evaluations include</p><ul><li>FDA Final Guidance on exposure-response relationships - study design, data analysis and regulatory applications. [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf">PDF</a>]</li><li>Pharmacokinetics in Pregnancy— Study Design, Data Analysis, and Impact on Dosing and Labeling [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072133.pdf">PDF</a>] -</li><li>Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population [<a href="http://www.emea.europa.eu/pdfs/human/ewp/14701304en.pdf">PDF</a>] - Efficay and safety data from adults can be extrapolated to obtain PK information for paediatric patients. When PK studies are to be carried out in paediatric population, PopPK studies with sparse sampling methodolgy seems to be the best approach. In young patients, there is rapid maturation of organs that are involved in drug absorption, distribution and elimination necessiating different dosage regimen. Thus for drugs that are intended to be used in paediatrics, this document provides recommendations on the study design of PK studies.</li></ul><p>More in my next post...</p>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-40797052040259728792008-11-14T10:43:00.004-05:002008-11-14T10:58:18.167-05:00AAPS Annual Meeting<span style="color:#000066;">I will be in Atlanta for AAPS meeting between 15-20 Nov. I would be happy to meet you, if you are planning to attend. Let me know via comments or by emailing me at ganesh.mugundu [at]gmail.com.</span>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com1tag:blogger.com,1999:blog-8876269157158031744.post-7812805018433486002008-11-03T19:56:00.008-05:002009-06-07T18:17:03.224-04:00NONMEM ResourcesI started learning NONMEM through a local discussion group headed by Dr. Alexander A. Vinks, at Cincinnati Childrens hospital. The small group comprised of few MS/PhD graduate students (including me) and faculty from pharmacy/mathematics. We have been meeting biweekly since 2006 and discuss about modeling data using NONMEM and other statistical softwares. Each of us had an opportunity to use real clinical data obtained from paediatric patients and develop PK/PD models to describe the data. We had guest lectures by Nick Holford MD, Dr. Roger Jeliffe MD, Jurgen Bulitta PhD about the use of NONMEM, USC Pack in population PK/PD modeling. Modeling and simulation has now become an integral part of drug development process and is being used regularly to model preclinical/clinical data.<br /><br />Ok. My main objective of this post was to share some resources that are available to learn model data using NONMEM. In addition to the above discussion group, I have learnt immensely from the following resources.<br /><br /><p><strong><span style="color: rgb(51, 51, 153);">a. Resources by Nick Holford</span></strong>: These course materials are freely available with enough background information to start performing population PKPD analysis. </p><ol><li><a href="http://www.fmhs.auckland.ac.nz/sms/pharmacology/holford/teaching/medsci719/timetable.aspx">Pharmacometrics</a></li><li><a href="http://www.fmhs.auckland.ac.nz/sms/pharmacology/holford/teaching/pharmacometrics/advanced.aspx">Advanced Pharmacometrics</a><span style="color: rgb(51, 51, 153);"><strong><span style="color: rgb(51, 0, 153);"></span></strong></span></li></ol><p><span style="color: rgb(51, 51, 153);"><strong><span style="color: rgb(51, 0, 153);">b.Resource</span> Facility for Population Pharmacokinetics[RFPK]</strong></span> – When accessing this site, you will have to fill a short questionnaire before downloading or viewing the tutorials/ presentations. </p><ol><li><a href="http://depts.washington.edu/rfpk/training/tutorials/index.html">Tutorials</a></li><li><a href="http://depts.washington.edu/rfpk/training/presentations/index.html">Presentations</a></li><li><a href="http://depts.washington.edu/rfpk/service/datasets/index.html">Datasets</a></li></ol><p><strong><span style="color: rgb(51, 51, 153);">c. Nonlinear mixed effect models: an overview and update</span></strong> [<a href="http://www4.stat.ncsu.edu/%7Edavidian/nlmmtalk.pdf">PDF</a>] </p><p><strong><span style="color: rgb(51, 51, 153);">d. Laboratory of Applied Pharmacokinetics (LAPK) teaching resources by Roger Jeliffe.</span></strong></p><ol><li>New Advances in PK/PD Modeling [<a href="http://www.lapk.org/pubsinfo/newadvances.php">PDF</a>]</li><li>Pop PK: Parametric & Non parametric Approaches [<a href="http://www.lapk.org/pubsinfo/pdf/MathMod1.pdf">PDF</a>] </li><li>Bayes Theorem and Other PK resources [<a href="http://www.lapk.org/pubsinfo/teaching_topics.php">PDF</a>] </li></ol><p>e. <a href="http://accp1.org/pharmacometrics/PKPDCourse2006/index.htm">Pharmacometrics by ACCP</a></p><p>f. Regulatory Guidances</p><ol><li>US FDA Population Pharmacokinetics [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072137.pdf">PDF</a>]</li><li>EMEA Guideline on Reporting the Results of Population Pharmacokinetic Analyses [<a href="http://www.emea.europa.eu/pdfs/human/ewp/18599006enfin.pdf">PDF]</a></li></ol><p><span style="font-size:85%;"><span style="font-size:100%;">If you know of more resources that can be added to this list, please feel free to provide the information by way of comments. Good night!</span> </span></p><p> </p>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com24tag:blogger.com,1999:blog-8876269157158031744.post-57193941174104420872008-11-01T11:57:00.007-04:002015-12-13T20:08:29.306-05:00Data Presentation<div dir="ltr" style="text-align: left;" trbidi="on">
Here is an excellent video on data presentation by Hans Rosling.<br />
<br />
<br />
<div class="separator" style="clear: both; text-align: center;">
<iframe width="320" height="266" class="YOUTUBE-iframe-video" data-thumbnail-src="https://i.ytimg.com/vi/hVimVzgtD6w/0.jpg" src="https://www.youtube.com/embed/hVimVzgtD6w?feature=player_embedded" frameborder="0" allowfullscreen></iframe></div>
<!--cut and paste--><br />
Let me know your thoughts if you enjoyed this video!</div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-47518551381613454042008-10-29T17:46:00.003-04:002008-10-29T17:52:39.043-04:00Good ModelingHere is something to think about...<br /><br />From a mathematical point of view, the art of <span style="color:#cc0000;">good modeling</span> relies on: (i) a<em> sound understanding and appreciation of the biological problem</em>; (ii) <em>a realistic mathematical representation of the important biological phenomena; (iii) finding useful solutions, preferably quantitative; and most crucially important, (iv) a biological interpretation of the mathematical results in terms of insights and predictions</em>. The mathematics is dictated by the biology and not vice versa. Sometimes the mathematics can be very simple. Useful mathematical biology research is not judged by mathematical standards but by different and no less demanding ones.<br /><br />- Jim Murray, 1993AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com1tag:blogger.com,1999:blog-8876269157158031744.post-30878375560614209952008-10-25T15:42:00.003-04:002008-10-25T15:56:20.499-04:00Hepatotoxicity in Drug Development<p>Liver toxicity has been one of the most common reasons for drug withdrawal in the past e.g Benoxaprofen (Oraflex), ticrynafen (Selacryn), bromfenac (Duract) and troglitizone (Rezulin). It has lead to black box warning for drugs like rifampicin, acetaminophen, valproic acid etc, due to their potential to cause liver injury. In some cases, drugs have not been approved because of its hepatotoxicity. Acetaminophen is a classic example where drug induced liver injury (DILI) is observed due to overdosage. The mechanism involves formation of a highly reactive metabolite N-Acetyl-p-benzoquinoneimine, by cytochrome P450 enzymes (CYPs) CYP2E1, CYP1A2, and CYP3A4. Accumulation of this metabolite results in cell death and hepatocellular necrosis. Patients with acetaminophen hepatotoxicity are treated with N-acetylcysteine, but still approximately 500 patients die each year.<br /><br />In the course of drug discovery and development, why is it difficult to determine the potential of a new chemical entity to cause hepatotoxicity or DILI? Though every compound undergoes rigorous testing in animal models and in vitro hepatocytes, most of the compounds pass through without being identified as hepatotoxic, probably due to lack of an appropriate model or due to differences in absorption, distribution, metabolism, elimination (ADME) between humans & animals. Other reasons include age, sex, genetic polymorphisms, disease conditions, drug -food and drug-drug interactions (CYP Induction/Inhibition). All these factors decrease the predictive power of non-clinical studies.<br /><br />An increase in levels of the liver enzymes like alanine aminotransferase (ALT) and aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin are signs of liver toxicity. Evaluation of these enzymes are routinely performed in clinical trials to assess drug induced liver injury. According to <a href="http://www.fda.gov/cber/gdlns/dili.pdf">FDA guidance document</a>, Hy’s Law (Hy Zimmerman) in determining DILI cases have the following three components:<br /><br />“<span style="color:#000066;"><em>1. The drug causes hepatocellular injury, generally shown by more frequent 3-fold or greater elevations above the ULN of ALT or AST than the (nonhepatotoxic) control agent or placebo.<br /></em></span><em><span style="color:#000066;">2. Among subjects showing such aminotransferase (AT) elevations, often with ATs much greater than 3xULN, some subjects also show elevation of serum TBL to >2xULN, without initial findings of cholestasis (serum alkaline phosphatase (ALP) activity >2xULN).<br />3. No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C, preexisting or acute liver disease, or another drug capable of causing the observed injury</span><span style="color:#000066;">.</em>”<br /></span><br />If a patient has found to have AT 3xULN or TBL is greater than 2xULN, the tests need to be repeated within 48-72 hours to confirm the abnormalities.<br /><br />A recent example of hepatotoxicity observed in a new drug and the response of FDA has been cited in a <a href="http://www.iom.edu/Object.File/Master/59/425/IOM%20Hepatotoxicity%20white%20paper%20final%2010-21-08.pdf">white paper </a>formulated for the workshop “Assessing and Accelerating Development of Biomarkers for Drug Safety” as follows<br /><br /><span style="color:#000066;"><em>“A major pharmaceutical company submitted an NDA application for treatment of a chronic disease. The FDA agreed with the sponsor’s efficacy data. However, it was noted that among ~4,000 treated patients in clinical trials, two developed elevations in both serum alanine aminotransferase and bilirubin. As a prerequisite for approval, the company was told to conduct a new safety study of 10,000 patients treated with drug for one year, and to also include an additional 10,000 subjects receiving comparator treatment for one year. This news will cost the company >$200M to conduct the trial, ~3 years off patent, and loss of market entry position in class.”<br /></em></span><br />This clearly shows how important it is to determine the toxicity to liver during the phases of drug development. I guess this post will stimulate some fruitful discussions and ideas related to DILI. </p><p><span style="color:#990000;">Other Guidances/References</span>: EMEA -Non-Clinical Guideline On Drug-Induced Hepatotoxicity[<a href="http://www.emea.europa.eu/pdfs/human/swp/15011506en.pdf">PDF</a>], FDA White Paper on Nonclinical Assessment of Potential Hepatotoxicity in Man [<a href="http://www.fda.gov/Cder/livertox/preclinical.pdf">PDF</a>] </p><p>Please feel free to share this post on <a href="http://technorati.com/tag/technocrati">technocrati </a>, <a href="http://delicious.com/">del.ici.ous </a>and <a href="http://digg.com/">digg</a>. </p>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-49385940979764182112008-10-23T07:22:00.005-04:002008-10-23T07:52:06.931-04:00A=X+Y+Z: Sucess Formula<span style="color:#000066;"><span style="color:#ff0000;"><span style="color:#000000;">Good Morning!<br /><br />Here is something simple to think about-<br /></span><br /></span><strong>"If A equal success, then the formula is A equals X plus Y and Z, with X being work, Y play, and Z keeping your mouth shut </strong></span><span style="color:#000066;">- <span style="color:#990000;">Albert Einstein</span><br /><br /><span style="color:#000000;">Wish you "A" in your day</span>!</span>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com1tag:blogger.com,1999:blog-8876269157158031744.post-188465022875013252008-10-20T23:16:00.009-04:002008-10-22T19:14:14.457-04:00MWSUG - Midwest SAS User Group Scholar<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgTfwt9YfwvPv9vkDDkej0gbcYJhwxu1ueFo2AH5qb-vmqval1UWRIRs_X9OXxS7Ma_dffa_W76DSZQdYnR9EoCFXHHR3rp1Vtiq3F5lBq0biRGv2oUDBNcbQlG6VE4N9LSYi-ePeY5Q1E/s1600-h/mwsug2.bmp"><img id="BLOGGER_PHOTO_ID_5259444960695925746" style="DISPLAY: block; MARGIN: 0px auto 10px; CURSOR: hand; TEXT-ALIGN: center" alt="" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgTfwt9YfwvPv9vkDDkej0gbcYJhwxu1ueFo2AH5qb-vmqval1UWRIRs_X9OXxS7Ma_dffa_W76DSZQdYnR9EoCFXHHR3rp1Vtiq3F5lBq0biRGv2oUDBNcbQlG6VE4N9LSYi-ePeY5Q1E/s400/mwsug2.bmp" border="0" /></a>I was fortunate enough to be selected as a student scholar in the recent midwest SAS user group conference held at Mariott Hotel, Indianapolis. This scholarship included a free registration and accomodation during the conference. It was a unique opportunity to mingle with SAS/JMP users from industry & academia and lean from the experts. The presentations were in the following categories <div></div><div></div><div></div><div><a href="http://www.mwsug.org/ind2008/presentations.html#appdev">Application Development</a><br /><a href="http://www.mwsug.org/ind2008/presentations.html#datavis">Data Visualization</a><br /><a href="http://www.mwsug.org/ind2008/presentations.html#pharma">Pharmaceutical Applications</a><br /><a href="http://www.mwsug.org/ind2008/presentations.html#sas">SAS Presents</a><br /><a href="http://www.mwsug.org/ind2008/presentations.html#stats">Statistics and Data Analysis</a><br /><a href="http://www.mwsug.org/ind2008/presentations.html#tutorials">Tutorials</a><br /><a href="http://www.mwsug.org/ind2008/jmp.html">JMP</a><br /></div><div>Being a midwest user's conference, I think MWSUG 2008 had around 400-500 attendees and was a small one when compared to AAPS with approximately 10,000 attendees. Dr. John Sall, Co-founder and Executive Vice President of SAS Institute and leader of the JMP business division was the key note speaker. He talked about the journey of JMP since late 1980s to the current version of JMP7.0. I especially enjoyed the talk on Mixed Effect Models and Bayesian analysis using SAS. I am not a SAS/JMP expert, but am comfortable using them for some of the statistical analysis.</div><div></div><div></div><div></div><div>In addition to the various presentations and hands on SAS workshop, MWSUG included a Las Vegas Casino Night with games like Craps, Blackjack, Roulette, 3-Card Poker, Money Wheel and Texas Hold’em Poker area. Each of us received a $500 fake money to play the games. This was the second time I was ever gambling in my life (can you believe that?) and in a Mariott turned Las Vegas Casino. The first time was when I visited Las Vegas and was trying my hand at the slot machines. Anyways, I did have fun on the casino night.</div><div></div><div></div><div></div><div>Did you have an experience similar to this? I would be happy to hear and learn from you! </div>AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com4tag:blogger.com,1999:blog-8876269157158031744.post-60198354077619719502008-10-18T22:28:00.002-04:002008-10-19T00:10:19.480-04:00Population Pharmacokinetics/PharmacodynamicsPopulation pharmacokinetics (PopPk) is the study of variability in plasma concentrations between and within individuals. It helps in identifying the demographic, pathophysiological, environmental and drug related factors that contribute to the variability observed in safety and efficacy of a drug. Unlike traditional PK studies where healthy volunteers are subjected to intensive sampling to determine PK parameters, PopPk studies offer an advantage of estimating PK parameters in target patient population with sparse sampling methodology. PopPK uses a nonlinear mixed effects modeling (NONMEM) approach. Variability in NONMEM is characterized in terms of fixed and random effects. The fixed effects are population average values of pharmacokinetic parameters such as clearance & volume of distribution, that may in turn be a function of patient characteristics. The random effects quantify the variability that is not explained by the fixed effects. These random effects include inter-subject, intra-subject, inter-occasion and residual variability. This methodology has also been extended to model population pharmacokinetic/pharmacodynamics (Pop PK/PD) relationships. This NONMEM approach was introduced by Lewis Sheiner and Stuart Beal approximately 30 years back. It has now become an integral part of drug development in industries and FDA review process.<br /><br />Some of the softwares that have been used for modeling are as follows<br />NONMEM (most widely used)<br />ADAPT<br />Monolix<br />NPEM<br />NPAG (USC*PACK)<br />WinNonmix<br />Kinetica<br />SAS (PROC NLMIXED)<br />Splus<br /><br />Pop PK/PD has led to a new discipline known as pharmacometrics. Barrett et al in J Clin Pharmacol 2008;48:632-649 define “Pharmacometrics” as that branch of science concerned with mathematical models of biology, pharmacology, disease, and physiology used to describe and quantify interactions between xenobiotics and patients, including beneficial effects and side effects resultant from such interfaces. So if you are a pharmacist, pharmacologist, statistician or biomedical engineer with good understanding of pharmacokinetics, pharmacodynamics, biological sciences, statistical and computational tools, you have a good chance to become a pharmacometrician. They are paid well both in the industry and the FDA. Infact, FDA has its own pharmacometrics group headed by Joga Gobburu and are promoting the use of modeling & simulation in drug development.<br /><br />Are you a pharmacometrician or a PK/PD scientist? Is there a specific software that you use to model the data?AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-10029962846331725402008-10-07T22:21:00.009-04:002014-03-29T14:50:30.351-04:00Bioavailability/Bioequivalence Guidelines <div dir="ltr" style="text-align: left;" trbidi="on">
<div align="left">
Sometimes its hard to find regulatory guidance documents on the web. One has to scroll through several pages before you actually find what you need. To make things easier, I previously had a webpage where the Bioavailability/Bioequivalence (BA/BE) guidances of various countries were put together under one page. Now, I will be posting the guidance documents on various topics on this blog. Today, I will start with BA/BE and cover as many topics in clincal pharmacology as possible in the future. If you are working in the generics industry and happen to do clinical studies supporting the <a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm">ANDA</a> (Abbreviated New Drug Application), you may want to bookmark this page and become familiar with following documents.</div>
<br />
<span style="color: #cc0000; font-style: italic; font-weight: bold;">Note: All links have been updated (March 2014).</span><br />
<br />
<div align="left">
</div>
<div align="left">
</div>
<div align="left">
<b><span style="color: #000099;">US FDA </span></b></div>
<div align="left">
1. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (Issued 3/2003, Posted 3/19/2003)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf">PDF</a>]<br />
<b>NEW DRAFT FOR COMMENTS</b>: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs- General Considerations (Issued 3/2014)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf">PDF</a>]</div>
2. <span style="color: #660000;">Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application- Draft (12/2013)</span> [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf">PDF</a>]<br />
3. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf">PDF</a>]<br />
4. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Posted 8/31/2000) [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf">PDF</a>]<br />
5. Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003) [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf">PDF</a>]<br />
6. Handling and Retention of BA and BE Testing Samples (5/25/2004) [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072869.pdf">PDF</a>]<br />
7. Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf">PDF</a>]<br />
8. Submission of Summary Bioequivalence Data for ANDAs (04/2009) [P<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134846.pdf">DF</a>]<br />
9. Bioequivalence Recommendations for Specific Products (06/2010) [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072872.pdf">PDF</a>]<br />
10. Bioanalytical Method Validation (05/2001)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf">PDF</a>]. This guidance is under revision and the draft version dated 09/2013 has been distributed for comments.(09/2013)[<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf">PDF</a>]<br />
11.<a href="http://www.fda.gov/Drugs/InformationOnDrugs/ucm135742.htm"> Dissolution Methods Database </a><br />
<br />
<div align="left">
</div>
<div align="left">
<span style="color: #000099;"><b>EMA</b></span></div>
<div align="left">
<span style="color: black;">1. Guideline on the Investigation of Bioequivalence (08/2010)[<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf">PDF</a>]</span></div>
<div align="left">
<span style="color: black;"></span></div>
<div align="left">
2. Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): <span style="color: #660000;">Presentation of biopharmaceutical and bioanalytical data in module 2.7.1</span> (06/2012) <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500117887.pdf">[PDF</a>]<br />
3. Questions & Answers:Positions on specific questions addressed to the pharmacokinetics working party (10/2013) [<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002963.pdf">PDF</a>]<br />
4. Bioanalytical Method Validation (02/2012) [<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf">PDF</a>]<br />
5. Modified-release oral and transdermal dosage forms: Section II (01/2000) [<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003126.pdf">PDF</a>]<br />
6. Pharmacokinetic and clinical evaluation of modified-release dosage forms- draft (2013)[<a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140482.pdf">PDF</a>]</div>
<br />
<div align="left">
</div>
<div align="left">
<b><span style="color: #000099;">CANADA (HPMB)</span></b></div>
Bioavailability and Bioequivalence [<a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/index-eng.php">html</a>]<br />
<br />
<b><span style="color: #000099;">AUSTRALIA (TGA)</span></b><br />
Guidance on the Investigation of Bioequivalence [<a href="http://www.tga.gov.au/pdf/euguide/ewp140198rev1.pdf">PDF</a>].<br />
TGA has adopted the EMA guidance document with the note "While this guidance suggests that the design and conduct of the study
should follow EU regulations on Good Clinical Practice, sponsors should
note that the EU Note for Guidance on Good Clinical Practice
(CPMP/ICH/135/95) has been adopted in Australia with TGA annotations.<br />
<span style="color: #351c75;"><br /></span>
<span style="color: #351c75;"><b>JAPAN [PMDA]</b></span><br />
There is no official english version of the guidance document, but the presentation on "<span style="color: #990000;">Approval Review of Generic Drugs in Japan"</span> available <a href="http://www.congre.co.jp/igpa2012/common/pdf/presentation/workshop/track1/k_saito.pdf">here</a> and <a href="http://www.pmda.go.jp/regulatory/file/english_presentation/generic_OTC/GO-E1osa.pdf">here</a> by the reviewers from the Office of Generic Drugs, PMDA may be beneficial.<br />
<br />
<b><span style="color: #351c75;">INDIA [CDSCO]</span></b><br />
<a href="http://cdsco.nic.in/html/BE_Document.htm">Draft Guidelines for Bioavailability/Bioequivalence Studies on Conventional and Extended Release Dosage Forms </a><br />
<br />
BEBAC- Helmut Schütz also maintains a comprehensive list of BABE guidelines for almost all the countries and you can find it <a href="http://bebac.at/Guidelines.htm">here</a>.<br />
<br />
Let me know if I am missing something!</div>
AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com11tag:blogger.com,1999:blog-8876269157158031744.post-80961384082740943052008-10-03T22:45:00.003-04:002008-10-03T22:56:29.270-04:00A cup of TeaOne of my favorite Zen story - A cup of Tea<br /><br />Nan-in, a Japanese master during the Meiji era (1868-1912), received a university professor who came to inquire about Zen.<br /><br />Nan-in served tea. He poured his visitor's cup full, and then kept on pouring.<br /><br />The professor watched the overflow until he no longer could restrain himself. "It is overfull. No more will go in!"<br /><br />"Like this cup," Nan-in said, "you are full of your own opinions and speculations. How can I show you Zen unless you first empty your cup?"<br /><br />What do you think?AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0tag:blogger.com,1999:blog-8876269157158031744.post-53125780653612592242008-07-14T21:01:00.008-04:002008-07-15T22:26:52.758-04:00Clinical Pharmacology & Translational ResearchThis year AAPS is hosting the national symposium at Atlanta, Georgia between November 16-20. I usually attend most of the presentations beginning from the sunrise session to the last one in the evening. The CPTR (Clinical Pharmacology & Translational Research) section has some very interesting sessions covering pharmacogenetics, modeling & simulation, biomarkers, pharmacokinetic models, drug metabolism & transport and is truly <em><span style="color:#000066;"><strong>translational.</strong></span> </em><span style="color:#000000;">Here is the list of CPTR sessions.</span><br /><br />Sunday, November 16, 8:30 am – 4:00 pm<br />Short Course #5: <strong>Pharmacodynamic Modeling of Non-standard Endpoints</strong><br /><br />Tuesday, November 18, 7:00 am – 8:15 am<br /><strong>Clinical Applications of Pharmacogenetics Sunrise Session</strong><br /><br />Tuesday, November 18, 8:30 am – 11:00 am<br /><strong>Diabetes Disease Progression Modeling Symposium</strong><br /><br />2:00 pm – 4:00 pm<br /><strong>Quantitative Clinical Pharmacology Analyses: Communicating to Influence Decisions Roundtable</strong><br /><br />2:00 pm – 4:30 pm AAPS/ACCP Joint Symposium:<br /><strong>Success Achieved and Challenges Ahead in Translating Biomarkers into Clinical Applications</strong><br /><br /><strong>Why Absorption and Pharmacokinetic Models Are More Important in Future Drug Development Symposium</strong><br /><br />7:00 pm – 9:30 pm <strong>Controversies in PK/PD Model Development Open Forum</strong><br /><br />Wednesday, November 19 8:30 am – 11:00 am<br /><strong>Modeling and Simulation Strategies for Evaluation of Drug Safety in Clinical Studies</strong><br /><br />Symposium 2:00 pm – 4:00 pm<br /><strong>The Impact of Kidney Disease/Renal Impairment on Drug Metabolism and Transport Roundtable</strong><br /><br />I bet it's gonna be a good learning experience listening to leading experts in the field talk on these topics. What do you think? Will you be coming to AAPS this year? Do you have a poster/podium presentation? Are you an invited speaker? Apart from all the scientific talks, AAPS is a good place to meet friends, previous colleagues and provides ample opportunity for networking.<br /><br />I hope to see you at AAPS meeting in Georgia. Take care!AM Lexihttp://www.blogger.com/profile/13676082197909020906noreply@blogger.com0