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!.

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 (http://www.youtube.com/metruminst). 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!