ProductDevelopmentCaseStudyOverview分析.pptVIP

Product Development:Case Study Overview Disclaimer The information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop. Purpose of Case Study Illustrative example Covers the concepts and integrated implementation of ICH Q8, 9 and 10 Not the complete content for a regulatory filing Note: this example is not intended to represent the preferred or required approach. Case Study Organization Basis for Development Information Fictional active pharmaceutical ingredient (API) Drug product information is based on the ‘Sakura’ Tablet case study Full Sakura case study can be found at http://www.nihs.go.jp/drug/DrugDiv-E.html Alignment between API and drug product API Particle size and drug product dissolution Hydrolytic degradation and dry granulation /direct compression Organization of Content Quality Target Product Profile (QTPP) API properties and assumptions Process and Drug product composition overview Initial risk assessment of unit operations Quality by Design assessment of selected unit operations Technical Examples API Drug Product Process Step Analysis For each example Risk assessment Design of experiments Experimental planning, execution data analysis Design space definition Control strategy Batch release Introducing API and Drug Product Assumptions API is designated as Amokinol Single, neutral polymorph Biopharmaceutical Classification System (BCS) class II – low solubility high permeability API solubility (dissolution) affected by particle size Degrades by hydrolytic mechanism In vitro-in vivo correlation (IVIVC) established – allows dissolution to be used as surrogate for clinical performance Drug product is oral immediate release tablet Assumptions Prior Knowledge API is designated as Amokinol Single, neutral polymorph Biopharmaceutical Classification System (BCS) class II – low solubility high permeability API solubility