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General Principles of pharmacology

院内药理学辅助学习站点 汕大医学院药理学精品课程网站

http://pharm.med.stu.edu.cn/

汕大医学院数字化学习平台 (SUMC E-Learning Platform) http://elp.med.stu.edu.cn/

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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

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Chapter One

Introduction

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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

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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

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Pharmacodynamics

Effect, Mechanism

Absorption, Distribution,

Metabolism, Elimination

Pharmacokinetics

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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)

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Source of drugs：

Ancient ： Natural products ( Plants, Animals and Minerals )

Modern ： Active constituent of natural products

Artificial Synthetics

(Raw opium)

(Opium tincture)

(Poppy)

morphine codeinenarcotinePapaverine

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: 11-15 Years

临床前药理学

临床前毒理学

筛选数百万化合物

IdeaIdea DrugDrug11 - 15 Years

1 – 2 1 – 2 产品

Phase I Phase II Phase III

00 151555 1010

临床药理学和毒理学

~100 ~100 设计方案设计方案~100 ~100 设计方案设计方案

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

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– 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.

– In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

– 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.

– In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

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”。