TY - CHAP M1 - Book, Section TI - Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence A1 - Calvin Sun, Changquan A1 - B.C. Yu, Andrew A1 - Shargel, Leon A2 - Ducharme, Murray P. A2 - Shargel, Leon PY - 2022 T2 - Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e AB - Define active pharmaceutical ingredient1 (API) and drug product (finished dosage form).Define pharmaceutical equivalence (PE) and therapeutic equivalence (TE).Describe the physical and biopharmaceutical properties of API that are important in the design and performance of drug products.Describe the main methods used to test PE of the API or the dosage form (drug product).Explain the relationship of PE, bioequivalence (BE), and TE.Explain whether a generic drug product that is not an exact PE can be TE.Explain why a generic drug product with identical PE may not lead to equivalent pharmacokinetic and pharmacodynamic performance.Define complex drug products and explain the problems for establishing pharmaceutical equivalence for these products. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1188771697 ER -