D1S20-Kim-v1.2-FINAL.pdf

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1、Product-Specific Guidances in Action:Key Lessons and Common Questions in Oral Drug Products Myong Jin Kim,Pharm.D.,FCPDirectorDivision of Therapeutic Performance II,Office of Research and Standards Office of Generic DrugsCDER|U.S.FDAGeneric Drugs Forum April 22,2026www.fda.gov2Learning Objectives Di

2、scuss FDAs key updates and proactive approaches in PSG development of oral drug products M13A implementation of IR drug products BCS-based biowaiver options Suitability petitioned dosage forms and strengths Cross-referencing approaches NTI drugs Discuss FDAs efforts for increased transparency in PSG

3、sPSG:product-specific guidance;M13A:Guidance for Industry-M13A bioequivalence for immediate-release solid oral dosage forms;IR:immediate release;BCS:biopharmaceutics classification system;NTI:narrow therapeutic index;https:/www.fda.gov/media/165049/downloadwww.fda.gov3FDAs Efforts in Implementing M1

4、3A into PSGs Since Oct 2024 Assessed risk evaluation for“High-Risk”and“Non-High-Risk”for IR drugs products The most significant change to PSGs(2 BE studies to 1 BE study)Of 1340 oral IR PSGs,about 77%recommend 1 BE study(either fasting or fed)reduce the need for additional in vivo BE studies and sup

5、port streamlined global drug developmentBE:Bioequivalence;https:/www.fda.gov/media/165049/downloadwww.fda.gov4BCS-based Biowaiver and PSGs BCS-based biowaiver options In general,a BCS-based biowaiver option is included in PSGs when the Agency has determined that a drug product is either BCS I or III

6、 A waiver request of in vivo testing based on its BCS class I or III Useful option especially in lieu of patient-based BE study(typically a steady state PK or comparative clinical endpoint)BCS-based biowaiver as an alternative approach Products that may be eligible for a BCS class III-based biowaive