Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs
Di Wu, Maitri Sanghavi, Sivacharan Kollipara, Tausif Ahmed, Anuj K Saini, Tycho Heimbach
Topics & Concepts
BioequivalenceBiopharmaceuticsBiopharmaceutics Classification SystemDissolution testingInnovatorPharmacologyCritical quality attributesIVIVCGeneric drugInterchangeabilityComputer scienceBiochemical engineeringBioavailabilityMedicineRisk analysis (engineering)New product developmentDrugEngineeringChemistryBusinessPharmacognosyMarketingBiological activityIntellectual propertyOperating systemBiochemistryProgramming languageIn vitroDrug Solubulity and Delivery SystemsCrystallization and Solubility StudiesProtein purification and stability