Friday, November 14, 2008

AAPS Annual Meeting

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.

Monday, November 3, 2008

NONMEM Resources

I 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.

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.

a. Resources by Nick Holford: These course materials are freely available with enough background information to start performing population PKPD analysis.

  1. Pharmacometrics
  2. Advanced Pharmacometrics

b.Resource Facility for Population Pharmacokinetics[RFPK] – When accessing this site, you will have to fill a short questionnaire before downloading or viewing the tutorials/ presentations.

  1. Tutorials
  2. Presentations
  3. Datasets

c. Nonlinear mixed effect models: an overview and update [PDF]

d. Laboratory of Applied Pharmacokinetics (LAPK) teaching resources by Roger Jeliffe.

  1. New Advances in PK/PD Modeling [PDF]
  2. Pop PK: Parametric & Non parametric Approaches [PDF]
  3. Bayes Theorem and Other PK resources [PDF]

e. Pharmacometrics by ACCP

f. Regulatory Guidances

  1. US FDA Population Pharmacokinetics [PDF]
  2. EMEA Guideline on Reporting the Results of Population Pharmacokinetic Analyses [PDF]

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!

Saturday, November 1, 2008

Data Presentation

Here is an excellent video on data presentation by Hans Rosling.



Let me know your thoughts if you enjoyed this video!