RT Book, Section A1 Calvin Sun, Changquan A1 B.C. Yu, Andrew A1 Shargel, Leon A2 Ducharme, Murray P. A2 Shargel, Leon SR Print(0) ID 1188771697 T1 Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence T2 Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e YR 2022 FD 2022 PB McGraw-Hill Education PP New York, NY SN 9781260142990 LK accesspharmacy.mhmedical.com/content.aspx?aid=1188771697 RD 2024/03/28 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.