Transcription of BIOPHARMACEUTICS CLASSIFICATION SYSTEM
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BIOPHARMACEUTICS CLASSIFICATION SYSTEM
BIOPHARMACEUTICS CLASSIFICATION SYSTEMB asic Absorption and DispositionDrug at Absorption SiteDrug in BodyExcreted DrugMetabolitesabsorptionmetabolismexcre tionClinical Pharmacokinetics, Rowland and Tozer, 2nd Ed, Lea & Febiger, 1989 These models use curve-fitting techniques to estimate kinetic rate constants and other parameters from time-course data for blood, tissue, or excreta; however, the curve-fitted parameters lack biological , J., Pharmac Ther, 12:537-562, 19812 PharmacokineticsDISPOSITION OF DRUGSThe disposition of chemicals entering the body (from Klaassen, Casarett and Doull s Toxicology, 5th ed., New York: McGraw-Hill, 1996).Introduction BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) Scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability What is the need for a CLASSIFICATION based on BIOPHARMACEUTICS of the drug?
previously in approved IR solid dosage forms. ... •Excipients (lubricants, suspending agents, etc) 40 Conditions that May Affect Drug Dissolution and Release: methodology related –Medium • Volume • pH • Molarity • Co-solvents, added enzymes/surfactants
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