Achieving a Harmonized Guideline for Bioanalytical Method Validation: ICH M10


Global input on harmonizing bioanalytical method validation solidified scientists’ vision and outlined universal challenges with existing guidelines.

By Faye Vazvaei, M.S., Roche Innovation Center New York; Lakshmi Amaravadi, Ph.D., Shire Plc; Lindsay King, Ph.D., Pfizer Inc.; Philip Timmerman, European Bioanalysis Forum; Yoshiaki Ohtsu, Ph.D., Astellas Pharma Inc.; and Eric N. Fluhler, Ph.D., Glenmark Pharmaceuticals

The importance of pharmacokinetics characterization in evaluating the safety and efficacy of drugs has given rise to a need for guidance in ensuring the accuracy and reproducibility of the underlying bioanalytical data.

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May 2018

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