Table of ContentsER Guidance Guidance for IndustryExtended Release Oral Dosage Forms Topics Evolution of IVIVC Activity Basic Concept Whats in the Guidance? General Considerations Developing an IVIVC Alter dissolution conditions Dosage Form Properties Developing an IVIVCmost commonly seen process Developmentdissolution data Development Developmentbioavailability data Developmentfraction absorbed Developmentfraction absorbed/dissolved IVIVC3 formulations IVIVC3 formulations IVIVC slow IVIVC medium IVIVCfast IVIVC slow and medium Development Checklist Evaluation of Predictability Estimation of prediction error internally Estimation of prediction error externally Additional test data setsdecreasing order of preference Overall IVIVC Process Methods for Evaluation of Predictability Internal Predictability Internal Predictability Evaluation of Predictabilityinternal External Predictability External Predictability Evaluation of Predictability external Summary Acknowledgements |
Author: Hank Malinowski
Email: malinowski@cder.fda.gov Home Page: http://www.fda.gov/cder/dpe1.htm Other information: Best experienced with Download Microsoft PowerPoint Animation Player for ActiveX Download presentation source (360k zip) |