The Use of Physiologically Based Pharmacokinetic Analyses—in Biopharmaceutics Applications -Regulatory and Industry Perspectives
Om Anand, Xavier Pépin, Vidula Kolhatkar, Paul Seo
Topics & Concepts
BiopharmaceuticsPhysiologically based pharmacokinetic modellingRisk analysis (engineering)BioequivalenceQuality (philosophy)Product (mathematics)Pharmaceutical industryComputer scienceDrug developmentPharmacologyRegulatory scienceBiochemical engineeringMedicineManagement scienceDrugPharmacokineticsEngineeringChemistryMathematicsBiological activityBiochemistryPathologyGeometryPharmacognosyPhilosophyEpistemologyIn vitroStatistical Methods in Clinical TrialsBiosimilars and Bioanalytical MethodsPharmacogenetics and Drug Metabolism