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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

2023The AAPS Journal29 citationsDOI

Topics & Concepts

BiopharmaceuticsBiopharmaceutics Classification SystemWorkflowRisk assessmentRisk analysis (engineering)Computer sciencePharmacologyMedicineBioavailabilityChemistryBiochemistryComputer securityPharmacognosyDatabaseBiological activityIn vitroComputational Drug Discovery MethodsBiosimilars and Bioanalytical MethodsProtein purification and stability
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions | Litcius