D1S19-Wang-v1.2-FINAL.pdf

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1、Decoding Product-Specific Guidances(PSGs)for Complex Non-Oral GenericsYan Wang,Ph.D.Deputy Division DirectorOffice of Research and Standards(ORS)|Office of Generic Drugs(OGD)|Center for Drug Evaluation&Research(CDER)Generic Drug Forum,April 22,20262Learning Objectiveswww.fda.gov Understand the scien

2、tific and regulatory logic underlying PSG development Systematically interpret PSG recommendations for complex non-oral products Be aware of responses to frequently asked questions on PSGs Translate PSGs into actionable generic development strategies3How is a PSG developed?www.fda.govPSGs operationa

3、lize a science-based pathway from product complexity to BE strategy and product developmentThree key questions1.What makes the product complex?2.What attributes control product performance?3.What study type best evaluates the identified product attributes to establish BE?4Question 1:What Makes This

4、Product Complex?Identify the source of complexity:Complex Active IngredientoExamples:iron-carbohydrate complexes,polymeric drug substances,oligonucleotides Complex Formulationso Examples:suspensions,emulsions,nanoparticles,microspheres,liposomesComplex Route of Deliveryo Examples:ophthalmic,inhalati

5、on,topical,intrauterineComplex Deviceso Examples:autoinjector5Question 2:What Attributes Control Clinical Performance?Determine the critical quality attributes(CQAs)as they are proxies for product performance Examples(not exhaustive CQAs per example):6Question 3:What Study Type Best Evaluates These

6、Attributes?PSGs translate CQAs into appropriate BE studies:Possible study types:Conventional:PK BE studiesComparative Clinical endpoint BE studiesPharmacodynamic studiesComplex products often involve a totality-of-evidence approach.oTier 1:Pivotal BE evidence(PK,clinical,validated in vitro BE)oTier