OSIS 在开展简化新药申请 (ANDA) 体外生物等效性 (BE) 研究检查和远程监管评估 (RRA) 中的作用-Mirza.pdf

1、OSIS Role in Conducting Inspections and Remote Regulatory Assessments(RRAs)of Abbreviated New Drug Application(ANDA)In Vitro Bioequivalent(BE)StudiesTahseen Mirza,PhD,MBA Associate Director for Regulatory Affairs Office of Study Integrity and SurveillanceOTS|CDER|US FDAGeneric Drug Forum 2025 April

2、10,2025fda.gov/cdersbiafda.gov/cdersbia2DisclaimerThis presentation reflects the views of the author.It should not be construed to represent FDAs views or policies.fda.gov/cdersbiafda.gov/cdersbia3Learning Objectives Describe types of in vitro BE studies Describe the process Office of Study Integrit

3、y and Surveillance(OSIS)utilizes in conducting inspections and Remote Regulatory Assessments(RRAs)of sites that perform in vitro ANDA BE studies fda.gov/cdersbiafda.gov/cdersbia4What is an In vitro BE study?320.24 Types of evidence to measure bioavailability or establish bioequivalence.(a)FDA may re

4、quire in vivo or in vitro testing,or both,to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products.In vivo test is preferred.however(b)The following in vivo and in vitro approaches,in descending order of accuracy,sensitivity,and reproducibility,are a

5、cceptable for determining the bioavailability or bioequivalence of a drug product.(5)A currently available in vitro test acceptable to FDA(usually a dissolution rate test)that ensures human in vivo bioavailability.fda.gov/cdersbiafda.gov/cdersbia5What is an in vitro BE study?.continued When mentione

6、d in a Product Specific Guidance(PSG).PSG is a guidance which describes FDAs current thinking.When it supports a BE determination.When it allows biowaivers.When used as supportive information along with in vivo data.fda.gov/cdersbiafda.gov/cdersbia6Commonly Inspected in vitro BE Studies Bile Acids b