TY - CHAP M1 - Book, Section TI - Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development A1 - Murray P., Ducharme A1 - Olga, Ponomarchuk A1 - Dana, Bakir A1 - Deniz, Ozdin A1 - Leon, Shargel A2 - Ducharme, Murray P. A2 - Shargel, Leon PY - 2022 T2 - Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e AB - To provide a description of the drug development process in the context of PK/PD studies.To highlight the main types of regulatory submission pathways and details what is specific to the United States, the European Union, and Canada.To give an overview of the critical PK information that is to be presented in the label and/or monograph after appropriately conducting PK/PD study.To describe the importance of the relative bioavailability of a drug depending on the different routes of administration.To specify the impact of PK nonlinearity on dosing regimen adjustments.To describe the objectives of an appropriately conducted single ascending dose (SAD) study and how it relates to multiple ascending dose (MAD) study.To describe the objectives of an appropriately conducted SAD study.To explain why food effect studies are usually conducted with a high-fat high-calorie breakfast.To describe the objectives of a mass balance study.To define the relationship between drug clearance, renal clearance, and non-renal clearance in a renal impairment study.To describe the importance of measuring unbound concentrations in a liver impairment study.To describe the design of a drug–drug interaction study with consideration to induction, irreversible inhibition, or reversible inhibition.To describe the importance of assessing QT prolongation for new drug products.To describe the importance of conducting population PK/PD studies in all stages of the drug development process.To provide a description on how to step-by-step validate a population PK model. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1188772471 ER -