POLYMORPHISM IN PHARMACEUTICAL SOLIDS

By ANTHONY GARCIA

CONTENTS INTRODUCTION TO GENERIC DRUG PRODUCT DEVELOPMENT ACTIVE PHARMACEUTICAL INGREDIENTS ANALYTICAL METHODS DEVELOPMENT AND METHODSVALIDATION FOR SOLID ORAL DOSAGE FORMS EXPERIMENTAL FORMULATION DEVELOPMENT SCALE-UP, PROCESSVALIDATION, AND TECHNOLOGYTRANSFER DRUG STABILITY QUALITY CONTROL AND QUALITYASSURANCE DRUG PRODUCT PERFORMANCE, INVITRO ANDA REGULATORYAPPROVAL PROCESS BIOEQUIVALENCE AND DRUG PRODUCT ASSESSMENT, INVIVO STATISTICAL CONSIDERATIONS FOR ESTABLISHING BIOEQUIVALENCE SCALE-UP, POST-APPROVAL CHANGES, AND POST-MARKETING SURVEILLANCE OUTSOURCING BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES TO CONTRACT RESEARCH ORGANIZATIONS LEGAL AND LEGISLATIVE HURDLES TO GENERIC DRUG DEVELOPMENT, APPROVAL, AND MARKETING