Skip to main content
Search

ICH S3A and S3B toxicokinetics and pharmacokinetics

Published on March 31, 2026   11 min

A selection of talks on Pharmaceutical Sciences

Please wait while the transcript is being prepared...
0:00
Hello. My name is David Jones, and I'm an Independent Consultant in Pharmacotoxicology. My previous life was as an assessor at the Medicines and Healthcare Products Regulatory Agency in the UK, where I spent 25 years as an assessor, primarily working within the clinical trials unit.
0:22
We all know about ICH. We all know where ICH came from, and in fact, it's been around now since about 1990, and ICH meetings are still held twice a year. The ICH S3A Note for Guidance on Toxicokinetics
0:36
came into regulatory acceptance in 1994. The S3B guideline on pharmacokinetics also came into being in October 1994, and a questions and answer document on S3A, which focused on microsampling and which I was the rapporteur for the EU was adopted in November 2017.
1:09
You should also note that there is a section on toxicokinetics and pharmacokinetics in the ICH M3(R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals. This discusses the timings of these studies, and the guideline is actually a subject of another talk in this series. Pharmacokinetics and toxicokinetics for biotechnology derived pharmaceuticals are covered in the ICH S6 (R1) guideline. This also is a subject of another talk in this series. Finally, the ICH S12 guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products was adopted in March 2023. Once again, this guideline is also the subject of another talk in this series.

Quiz available with full talk access. Request Free Trial or Login.

Show
Hide

ICH S3A and S3B toxicokinetics and pharmacokinetics

Embed in course/own notes