Regulatory Focus™ > News Articles > ICH Releases Additional Guidance on Combination Drug Toxicity Testing

ICH Releases Additional Guidance on Combination Drug Toxicity Testing

Posted 12 January 2012 | By Alexander Gaffney, RAC 

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.

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