Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions
Tausif Ahmed, Sivacharan Kollipara, Rajkumar Boddu, Adithya Karthik Bhattiprolu
Topics & Concepts
BiopharmaceuticsBiopharmaceutics Classification SystemWorkflowRisk assessmentRisk analysis (engineering)Computer sciencePharmacologyMedicineBioavailabilityChemistryBiochemistryComputer securityPharmacognosyDatabaseBiological activityIn vitroComputational Drug Discovery MethodsBiosimilars and Bioanalytical MethodsProtein purification and stability