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INTRODUCTION TO BIOPHARMACEUTICS AND PHARMACOKINETICS: - Drugs are substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. ~ Drug preduct performance is defined as the release of the drug substance from the drug preduct either for local drug action er for drug absorption into the plasma for systemic therapeutic activity. - Biopharmaceutics examines the interrelationship of the physical/ chemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption. - A pharmacodynamic response results when the drug concentration at the site of action reaches or exceeds the minimum effective concentration (MEC). —— The suggested dosing regimen, including starting dose, maintenance dose, dosage form, and desing interval, is determined in clinical trials te provide the drug concentrations that are therapeutically effective in most patients. ~ Isoproferenc] causes an increase in heart rate when given IV but has no observable effect on the heart when given erally at the same dese level. ~ The US FDA approves all drug preducts te be marketed in the US. The pharmaceutical manufacturers must perform extensive R & D prior to approval. The manufacturer of a new drug preduct must submit a New Drug Application (NDA) to the FDA, whereas a generic drug pharmaceutical manufacturer must submit an Abbreviated New Drug Application (ANDA). Both the new and generic drug product manufacturers must characterize their drug and drug product and demonstrate that the drug product performs appropriately before the products can become available +2 consumers in the US. ~ Drugs in Europe may be meeting EP (European Pharmacopeia) and since 2006, agreed uniform standards are harmonized in ICH guidances for Europe, Japan, and the US, In the US, the USP-NF is the official compendia for drug quality standards. - Biopharmaceutics involves factors that influence (I) the design of the drug preduct, (2) stability of the drug within the drug product, (3) the manufacture of the drug product, (4) the release of the drug from the drug product, (S) the rate of dissolution/ release of the drug at the absorption site, and (6) delivery of drug to the site of action, which may invelve targeting the drug te a localized area (eq, colon for Crohn disease) for action or for systemic absorption of the drug, - Studies in biopharmaceutics use beth in vitro and in vive methods. In vitro methods are procedures employing test apparatus and equipment without involving laboratory animals or humans. In vive 
