TY - CHAP M1 - Book, Section TI - Impact of Biopharmaceutics on Drug Product Quality and Clinical Efficacy A1 - Shargel, Leon A1 - Yu, Andrew A2 - Shargel, Leon A2 - Yu, Andrew B.C. PY - 2016 T2 - Applied Biopharmaceutics & Pharmacokinetics, 7e AB - Describe the types of safety and efficacy risks that may occur after taking a drug product and various means for preventing these risks.Differentiate between drug product quality and drug product performance.Differentiate between quality control and quality assurance.Explain how quality by design (QbD) ensures the development and manufacture of a drug product that will deliver consistent performance.Define quality target product profile (QTPP) and explain how QTPP is different than conventional quality product criteria.Identify various formulation and manufacturing process factors that affect product quality and performance and the concept of QTPP.Describe the quality principles underlying basis for the development, manufacture, and quality assurance of the drug product throughout its life cycle in QbD.Describe how product specifications relate to drug product quality and the relevance to quality assurance of the drug product through QbD.Describe a practical strategy to track risks in a drug product development by drawing a scientific roadmap for validating the overall process of material acquiring, manufacturing, and distributional steps involved in a drug product appropriately labeled for medical use.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.List the major reasons that a drug product might be recalled due to quality defects. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1117900840 ER -