ICH M9: BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS Questions and Answers

Titel:
ICH M9: BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS Questions and Answers
Internet:

https://www.gmp-navigator.com/files/guidemgr/M9_QAsAnnex_Step4_2019_1116.pdf

Herkunft/Verlag:

Inhalt:
The ICH M9 Guideline and Q&As provide recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies.

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