TY - CHAP M1 - Book, Section TI - Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance A1 - Suarez, Sandra A1 - Marroum, Patrick J. A1 - Hughes, Minerva A2 - Shargel, Leon A2 - Yu, Andrew B.C. PY - 2016 T2 - Applied Biopharmaceutics & Pharmacokinetics, 7e AB - Describe the biopharmaceutic factors affecting drug design.Define the term “rate-limiting step” and discuss how the rate-limiting step relates to the bioavailability of a drug.Differentiate between the terms solubility and dissolution.Differentiate between the concept of drug absorption and bioavailability.Describe the various in vitro and in vivo tests commonly used to evaluate drug products.Describe the statistical methods for comparing two dissolution profiles for similarity.List the USP dissolution apparatus and provide examples of drug products for which the dissolution apparatus might be appropriate.Define sink conditions and explain why dissolution medium must maintain sink conditions.Define in vitro–in vivo correlation (IVIVC) and explain why a Level A correlation is the most important correlation for IVIVC.Define clinically relevant drug product specifications and describe the methods to establish them.Explain the biopharmaceutic classification system and how solubility, dissolution, and permeation apply to BCS classification.Provide a description of some common oral drug products and explain how biopharmaceutic principles may be used to formulate a product that will extend the duration of activity of the active drug. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/29 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1117900197 ER -