1 General Principles of pharmacology

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3 Chapter 1. Introduction Chapter 2. Pharmacodynamics Chapter 3. Pharmacokinetics Chapter 4. Factors affecting drug efficacy About pharmacology What the body does to a drug What a drug does to the body How to use a drug rationally

4 Chapter One Introduction

5 Ⅰ、 Property and Contents of Pharmacology Pharmacology is the medical science that studies the nature and the properties of drugs, the interactions between drugs and the body 1. Pharmacology

6 Pharmacology can be studied at multiple “levels”: molecular, (sub)cellular, tissue, whole animal, or population. Clinical pharmacology is the study of drugs in human patients Toxicology is the study of harmful rather than therapeutic effects Pharmacy involves manufacture, preparation, and dispensing of drugs

Why are drugs important for health and scientific research?  From early in human history, pharmacologically active substances (e.g., from plants, animals) have been used to ward off or treat disease  Discovery and development of drugs (including immunotherapy/ vaccinations) has been a major factor that has increased life span and improved the quality of life 5

8 Pharmacodynamics Effect, Mechanism Absorption, Distribution, Metabolism, Elimination Pharmacokinetics

9 2. Drug A drug is a chemical substance that can modulate the current physiological status of a biological system. is defined as a chemical which is utilized for the diagnosis, prevention and cure of an unwanted health condition (definition by FDA)

10 Source of drugs ： Ancient ： Natural products ( Plants, Animals and Minerals ) Modern ： Active constituent of natural products Artificial Synthetics

(Raw opium) (Opium tincture) (Poppy) morphine codeine narcotine Papaverine

deadly nightshade ( 颠茄 ) atropine ( 阿托品 ) foxglove ( 毛地黄 ) digoxin ( 地高辛 )

No clear borderline between drug and poison “Poisons in small doses are the best medicines; and useful medicines in too large doses are poisonous” (William Withering, “discoverer” of digitalis, 1789) Snake venom Arsenic

High Risk Process: Years 临床前药理学 临床前毒理学 筛选数百万化合物 Idea Drug Years 1 – 2 1 – 2 产品 Phase IPhase IIPhase III 临床药理学和毒理学 ~100 设计方案 Pre-clinical

合成 筛选 The Long Road to a New Medicine I 期临床试验 II 期临床试验 III 期临床试验 临床前安 全有效性 药物制剂 候选化 合物 初步安全有 效性研究 设计 申请证书 上市 Process of Drug Development

16 –In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify adverse reactions.Phase I trials –In Phase II trials, the study drug or treatment is given to a larger group of people ( ) to see if it is effective and to further evaluate its safety.Phase II trials –In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor adverse reactions, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.Phase III trials –In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.Phase IV trials Clinical Trials

Remember: Drugs are developed to treat people-- not cells or experimental animals!!

Status of Pharmacology in Medicine Basic Medicine Clinical Medicine Medicine Pharmacy

药理学学习方法  综合性机能学科，与生理、病生联系 紧密。  抓住 “ 代表药 ” ，区别 “ 非代表药 ” 。