RT Book, Section A1 Shargel, Leon A1 Wu-Pong, Susanna A1 Yu, Andrew B.C. SR Print(0) ID 56604846 T1 Chapter 14. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance 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=56604846 RD 2024/03/28 AB Biopharmaceutics is the study of the physicochemical properties of the drug and the drug product, in vitro, on the bioavailability of the drug, in vivo, to produce a desired therapeutic effect. Biopharmaceutics links the physical and chemical properties of the drug and the drug product to their performance, in vivo. A primary concern in biopharmaceutics is the bioavailability of drugs. Bioavailability refers to the measurement of the rate and extent of active drug that becomes available at the site of action. Oral drug absorption involves at least three distinct steps: drug release and dissolution from the drug product, permeation of the drug across the gastrointestinal (GI) linings, and drug disposition during GI transit. Additional drug disposition may occur in the body. Because the systemic blood circulation delivers therapeutically active drug to the tissues and to the site of action of the drug, changes in bioavailability affect changes in the pharmacodynamics and toxicity of a drug. The aim of biopharmaceutics is to adjust the delivery of drug from the drug product in such a manner as to provide optimal therapeutic activity and safety for the patient.