Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives
Sivacharan Kollipara, Frederico Severino Martins, Maitri Sanghavi, Gustavo Mendes Lima Santos, Anuj Kumar Saini, Tausif Ahmed
Topics & Concepts
BioequivalenceBiopharmaceuticsBiopharmaceutics Classification SystemGeneric drugMedicinePharmacologyDrugPharmacokineticsChemistryBiological activityPharmacognosyBiochemistryIn vitroComputational Drug Discovery MethodsBiosimilars and Bioanalytical MethodsStatistical Methods in Clinical Trials