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Modified bacterial mutation test procedures for evaluation of peptides and amino acid-containing material
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6

August 2024

2024/2025

A+
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) consists of a series of committees, mainly concerned with standardizing the range of toxicology tests needed for new pharmaceuticals. ICH S2B guidance was finalized in 1997 and adopted by the US, European and Japanese regulatory authorities shortly after. The guidance indicates that the expected standard battery of genotoxicity tests normally required for small ...
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