TY - CHAP M1 - Book, Section TI - Rational Drug Product Development, Quality, and Performance A1 - Dixit, Trupti A1 - Shargel, Leon A2 - Ducharme, Murray P. A2 - Shargel, Leon PY - 2022 T2 - Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e AB - Describe the types of safety and efficacy risks that may occur after taking a drug product and various means for preventing these risks.List the major reasons that a drug product might be recalled due to quality defects.Understand how biopharmaceutics risk assessment road map (BioRAM) can lead to rational drug product development.Differentiate between drug product quality and drug product performance.Differentiate between quality control (QC) and quality assurance (QA).Explain how quality by design (QbD) ensures the development and manufacture of a drug product that will deliver consistent quality and performance.Define quality target product profile (QTPP) and explain how QTPP is different from conventional quality product criteria.Describe the quality principles underlying basis for the development, manufacture, and QA of the drug product throughout its life cycle.Describe how product specifications relate to drug product quality and the relevance to QA of the drug product through QbD.Define critical quality attributes and how these attributes relate to clinical safety and efficacy.Explain how postapproval changes in a drug product may affect drug quality and performance. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/29 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1188771893 ER -