Clinical Pharmacology – Chemical
2019 PharmSci 360
Prologue - Physiologically-based pharmacokinetic (PBPK) modeling may predict or describe the pharmacokinetics (PK) of drugs in healthy volunteers or specific populations. Readily available software platforms, recent regulatory guidances, new in silico ADMET tools as well as an increased awareness in academic institutions all have promoted PBPK as part of model informed drug development and regulatory approvals. PBPK models have now become a scientifically important tool to identify drug development risks and to address health authority questions. Verified PBPK models allow a mechanistic understanding of ADME processes, including food or formulations effects on drug absorption, Drug-Drug Interaction assessment or can aid in dosing selections and recommendations in specific populations including pediatrics and patients with organ impairment. Case examples will highlight how PBPK modeling can e.g. a) address regulatory questions, b) impact clinical trial designs, c) waive studies, d) inform the dosing regimen in specific populations and e) inform product-labeling language. The evolving roles of physiologically-based biopharmaceutics (PBBM) will also be covered. The session is expected to benefit both pharmaceutical scientists in academia or the industry interested in learning about PBPK opportunities and limitations.