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The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation. The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019.
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Fda Bcs Class
Were given BCS Class 1 determinations. Milan Samid of World Health Organization (WHO) discussed the WHO guidelines, specifically Technical Report Series, N. 937,2006, Annex 7 and 8 on interchangeability and BCS. There are some differences between the FDA BCS guidance and the WHO documents, specifically that Class 2 is eligible for. BCS, Biowaivers and Dissolution Test Methodologies Vinod P. Shah, Ph.D., FAAPS, FFIP Pharmaceutical Consultant, (Formerly with US FDA).