RT Book, Section A1 Shargel, Leon A1 Wu-Pong, Susanna A1 Yu, Andrew B.C. SR Print(0) ID 56605259 T1 Chapter 15. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence T2 Applied Biopharmaceutics & Pharmacokinetics, 6e YR 2012 FD 2012 PB The McGraw-Hill Companies PP New York, NY SN 978-0-07-160393-5 LK accesspharmacy.mhmedical.com/content.aspx?aid=56605259 RD 2024/11/14 AB Drug product performance,1in vivo, may be defined as the release of the drug substance from the drug product leading to bioavailability of the drug substance. The assessment of drug product performance is important since bioavailability is related to the pharmacodynamic response and related adverse events. Thus, performance tests relate the quality of a drug product to clinical safety and efficacy. Bioavailability studies are drug product performance studies used to define the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacture process of the drug product (dosage form). Bioavailability is one aspect of drug product quality that links the in vivo performance of a new drug product to the original formulation that was used in clinical safety and efficacy studies. Bioequivalence studies are drug product performance tests that compare the bioavailability of the same active pharmaceutical ingredient from one drug product (test) to a second drug product (reference). Bioavailability and bioequivalence can be considered as measures of the drug product performance in vivo.