TY - CHAP M1 - Book, Section TI - Drug Product Performance, In Vivo: Bioavailability and Bioequivalence A1 - Shargel, Leon A1 - Ducharme, Murray P. A2 - Ducharme, Murray P. A2 - Shargel, Leon PY - 2022 T2 - Shargel and Yu's Applied Biopharmaceutics and Pharmacokinetics, 8e AB - Define bioavailability, bioequivalence, and drug product performance.Explain why certain drugs and drug products have low bioavailability.Distinguish between relative bioavailability and absolute bioavailability.Explain why first-pass effect as well as chemical instability of a drug can result in low relative bioavailability.Distinguish between bioavailability and bioequivalence.Explain why relative bioavailability may have values greater than 100%.Explain why bioequivalence may be considered as a measure of drug product performance.Describe various methods for measuring bioavailability and the advantages and disadvantages of each.Describe the statistical criteria for bioequivalence and 90% confidence intervals.Explain the conditions under which a generic drug product manufacturer may request a waiver (biowaiver) for performing an in vivo bioequivalence study.Define therapeutic equivalence and explain why bioequivalence is only one component of the regulatory requirements for therapeutic equivalence. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/29 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1188767142 ER -