ICH Releases Additional Guidance on Combination Drug Toxicity Testing
Posted 12 January 2012 | By
The International Conference on Harmonization (ICH) released a new Question and Answer document on 11 January that provides additional guidance on ICH document M3(R2) - Combination Drug Toxicity Testing.
The new Q&A addresses a series of questions including:
- how to conducting toxicity testing on combination products with different toxicity profiles
- clarity regarding testing differences between the European medicines Agency and US Food and Drug Administration
- determining the dosage, duration and endpoint of toxicity studies
- testing non-fixed-dose combination products where one agent is a member of a class containing multiple approved products
- determining "adequate clinical experience with co-administration" in late stage products
- how to test multiple entity combinations when there is cause for concern
- determining if pharmacology studies replace combination toxicity studies in certain cases
- how to conduct toxicity testing for embryo-fetal development studies
- how to develop therapies for life-threatening or serious diseases
- how M3(R2) applies to biotechnology products
ICH M3(R2) is currently entering Step 5 which will further revise the guidance.
ICH documents are meant to bind the regulatory processes of the EU, US, and Japan.