Friday, December 22, 2017

FDA Commissioner Scott Gottlieb on Quantitative Methods in Drug Development

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 -
  • Adaptive and seamless clinical trial approaches
  • 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

Here is the transcript and a key message.
"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.
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."

Saturday, November 11, 2017

Sunday, December 20, 2015

Benefits of using modeling and simulation in drug development

Check out this video...a very nice illustration of how clinical pharmacologists use PKPD to influence decision making during drug development.

Sunday, December 13, 2015

Cancer Drug Costs

 Interesting read on a review of cancer drug costs by ASCO.

Cost of Developing a New Drug

Oncology and Dose Finding

Earlier this year, US FDA and AACR  cosponsored a public workshop titled “Dose-finding of Small Molecule Oncology Drugs.” There were several interesting presentations and recommendations on how we can optimize the dose and dosing schedule during development. As in other therapeutic . 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.

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.

Check out the agenda, slides and recorded presentation at Dose-finding of Small Molecule Oncology Drugs

Friday, December 27, 2013

Bioavailability/Bioequivalence Regulatory Guidance Documents- Link Updated

After a long time, I have gone back and updated the guidance documents in my original post "Bioavailability/Bioequivalence Guidelines". 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!.

Wednesday, December 25, 2013

Pharmacometric Tutorials

Some additional tutorials for learning population PK modeling and simulation have been published by  CPT: Pharmacometrics & Systems Pharmacology and are available for free under open access.

  1. Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development
  2. Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development—Part 2: Introduction to Pharmacokinetic Modeling Methods
  3. A Time to Event Tutorial for Pharmacometricians
  4. Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
Metrum Institute 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,
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 ( 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.
Happy Holidays!

Saturday, June 15, 2013

The Role of Clinical Pharmacology in the Trial of Conrad Murray

One of the key  highlights of ASCPT 2013 was the presentation by Dr. Shafer on "The Role of Clinical Pharmacology in the Trial of Conrad Murray". 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. This is a practical example of the utility of PK/PD modeling & simulation. So, sit back and enjoy the presentation.