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PHARMACEUTICAL INDUSTRY. Drug Discovery - natural sources, synthesis/modification. biological properties - pharmacology, pharmacokinetics. Preclinical Studies. preformulation - chem/phys properties - analytical assays. Formulation development of dosage form large-scale manufacturing.

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  1. PHARMACEUTICAL INDUSTRY Drug Discovery - natural sources, synthesis/modification biological properties - pharmacology, pharmacokinetics Preclinical Studies preformulation - chem/phys properties - analytical assays • Formulation • development of dosage form • large-scale manufacturing Approval for Distribution Clinical Trials Post-Marketing Surveillance CHEE 440

  2. Definitions drug - Any substance or mixture of substances manufactured, sold or represented for use in: a) the diagnosis, treatment, mitigation or prevention of a disease, a disorder, an abnormal physical state or the symptoms thereof in humans or animals b) restoring, correcting or modifying organic functions in humans or animals c) “disinfection” in premises in which food is manufactured, prepared or kept pharmaceutics - the area of study concerned with the formulation, manufacture, stability, and effectiveness of dosage forms pharmacology - the science of the properties of drugs and their effects on the body pharmacokinetics - the study of the kinetics of absorption, distribution, metabolism, and excretion of drugs and their corresponding pharmacologic response in animals/man clinic - a facility or area where ambulatory patients are seen for special study and treatment CHEE 440

  3. Need for Dosage Forms • provide safe and accurate delivery of given dosage • protect drug from environmental degradation • protect drug from GI degradation • conceal bitter, salty taste, offensive odor • allow for administration of poorly soluble drug • provide rate-controlled action • allow for admin. by desired route CHEE 440

  4. INTRODUCTION • drugs seldom administered alone • given as a formulation • contain additional ingredients called excipients • objective of dosage form design • achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality • must consider physical, chemical, biological properties of all components CHEE 440

  5. Excipients CHEE 440

  6. Routes of Administration CHEE 440

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