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Section I General principle of Pharmacology M.Y. Liu Where can you get information about general principle of Pharmacology? Text books: Katzung, Basic and Clinical Pharmacology For those who want to know more: Goodman and Gilman’s “The Pharmacological Basis of Therapeutics” By email: [email protected] Chapter 1 introduction What is a Drug? Any animal, vegetable or mineral substance used in the composition of medicines according to the Food, Drug, and Cosmetic Act a substance recognized in an official pharmacopoeia or formulary a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease a substance other than food intended to affect the structure or function of the body a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device Differences between drug and poison All the substances are poisons! There are no distinct borderline between them. Any drug will be toxic once they are overdosed. toxic dose; lethal dose What is Pharmacology? the study of how drugs affect a biological system Pharmacology Pharmacokinetics What the body does to drug Pharmacodynamics What the drug does to body Pharmacokinetics Pharmacokinetics is the description of the time course of a drug in the body, encompassing absorption, distribution, metabolism, and excretion. In simplest terms, it can be described as what the body does to the drug. Pharmacodynamics Pharmacodynamics is the study of the biochemical and physiological effects of drugs, in certain period. In brief, it can be described as what the drug does to the body. Drug receptors Effects of drug Responses to drugs Toxicity and adverse effects of drugs Drug development and approval Preclinical testing In vitro studies Postmarketing surveillance Clinical trials Animal testing Long-term toxicity studies NDA IND Phase 1 – normal volunteers: safety, pharmacokinetics (Phase 4) Phase 2 – selected patients: therapeutic efficacy, dose range Phase 3 – large populations of selected patients: therapeutic efficacy, safety in double blind studies 1 to 5 years Average years 2 to 10 years 1 year