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ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

2013; Springer Nature; Linguagem: Inglês

10.1007/978-1-4614-5950-7_10

2210-738X

Joy Cavagnaro, Jennifer Sims,

Protein purification and stability

Since its publication in 1997, the ICH guideline on the Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals ("ICH S6") has fostered consistency while maintaining the necessary flexibility for testing within and across a variety of product classes. Successful implementation of a product-specific science-based "case-by-case" approach however has required individuals with a broad knowledge of toxicological processes and the ability to integrate data from molecular biology, pharmacology, physiology, pharmacokinetics, and pathology. Importantly, the "case-by-case" approach only works if there is an understanding of the science and an acceptance by both regulators and industry that the interpretation of the data has to reflect best scientific practice and that no study in experimental animals can predict with certainty the outcome in humans. As such, a greater dialogue between industry and regulatory authorities has been needed early and in some cases throughout development to ensure that the decision on how a product should be tested not only meets the stringencies of the regulatory authorities but is also designed to improve the predictive value for extrapolating to humans. This dialogue between industry and regulatory authorities continued to the ICH Expert Working Group charged with formulating the addendum to ICH S6(ICH S6R(1) finalized at step 4 in June 2011), guidance based on the accumulated and collective experience of the safety assessment of biotechnology-derived pharmaceuticals in the 14 years since the finalization of ICH S6.