1. Section I General principle of Pharmacology

2. 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: saffer@163.com

3. Chapter 1 introduction

4. 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

5. 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

6. What is Pharmacology?  the study of how drugs affect a biological system Pharmacokinetics Pharmacodynamics What the body does to drug What the drug does to body Pharmacology

8. 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.

9. 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

10. Drug development and approval In vitro studies Preclinical testing Animal testing Clinical trials Average years 1 to 5 years 2 to 10 years1 year IND NDA Post- marketing surveillance (Phase 4) Phase 1 – normal volunteers: safety, pharmacokinetics Phase 2 – selected patients: therapeutic efficacy, dose range Phase 3 – large populations of selected patients: therapeutic efficacy, safety in double blind studies Long-term toxicity studies