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药理学总论-绪言 Pharmacology A Very Basic Intro PowerPoint Presentation
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药理学总论-绪言 Pharmacology A Very Basic Intro. What is a drug? any chemical agent which affects any biological process. Sources of Drugs. Animals Plants Minerals Synthetic Microbes Genetic engineering drugs. ③. ②限制酶截取 DNA 片断. ①. ④. ③分离大肠杆菌中的质粒. ②. ④ DNA 重组. ⑤. ⑤用重组质粒转化大肠杆菌.

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Presentation Transcript
slide1

药理学总论-绪言

Pharmacology

A Very Basic Intro

slide2

What is a drug?

          • any chemical agent which
  • affects any biological process
slide3

Sources of Drugs

Animals

Plants

Minerals

Synthetic

Microbes

Genetic engineering drugs

slide4

②限制酶截取DNA片断

③分离大肠杆菌中的质粒

④ DNA重组

⑤用重组质粒转化大肠杆菌

⑥培养大肠杆菌克隆大量基因

基因工程药物过程示意图

①从细胞中分离出DNA

slide6
A goal of Genomics is to find and express genes that code for unknown peptides with significant biological properties, like receptors or enzymes. In a reverse Pharmacology approach this peptide, e.g. a receptor, is then used to "fish" for a natural ligand . With receptor and ligand in hand the biological role of the receptor needs to be determined. Finally, screening for synthetic ligands as well as lead optimization can lead to new drug candidates. In contrast, the classical approach to drug discovery starts with the identification of a ligand that has biological activity that in turn is used to "fish" for the corresponding receptor.
slide7
One example for a Genomics strategy aims at identifying drug targets based on molecular homology within Gene-families. One of the most important families of drug-targets for the pharmaceutical industry is the family of G-protein coupled receptors (GPCRs). Of the top 200 best selling prescription drugs, more than 20% interact with GPCRs, providing worldwide sales of over $20 billion. The characteristic motif of the GPCR family is the seven distinct hydrophobic regions, each of 20 to 30 amino acids that form the transmembrane domain of these integral membrane proteins. This key amino-acid sequence motif can be found within all types of GPCRs and can be used to identify DNA-sequences that code for GPCRs.
slide8

What is pharmacology ?

          • the study of how drugs
  • effect biological systems
slide9

What is Pharmacology ?

Pharmacokinetics Pharmacodynamics

What the body does to drug What the drug does to body

Pharmacology

Pharmacotherapeutics Pharmacocognosy

The study of the use of drugs Identifying crude materials as drugs

Toxicology

slide10

Pharmacokinetics

What the body does to the drug

- Absorption

- Distribution

- Metabolism (Biotransformation)

- Excretion

Half-life (t1/2)

- the time required for the plasma

concentration of a drug to be reduced by 50 %

slide11

DRUG CLASSIFICATION

  • Based on the chemical structure
  • - Based on the main effect (e.g. analgesics).
  • - Based on the therapeutic use (e.g. antipsychotic 安定药).
  • Based on mechanism of action (e.g. serotonin agonist).
slide12

From Chemist

to

First In Man

…approximately 7 – 10 years

How a Drug becomes a drug…

slide13

Basic & Clinical Evaluation of New Drugs

  • Drug discovery & Drug screening
  • Chemistry
  • In Vitro Studies
  • Function in cells, tissues, and at receptors
  • 2. Preclinical safety & toxicity testing
  • In Vivo - Animal studies
  • Pharmacology and Behavioral Pharmacology
  • Potency and Efficacy – ED50
  • Tolerance and Tachyphylaxis(快速耐受)
  • Toxicity – Acute and Chronic
  • LD50
  • Teratogenicity = birth defects
  • Carcinogenicity = cancerous
  • 3. Evaluation of drug in humans

H. Haarmann University of Maryland, 2002

slide14

Evaluating Drugs in Humans

The Food and Drug Administration (FDA)

Phases of a Clinical Trials

Phase I

Phase II

Phase III

Phase IV

slide15

Evaluating Drugs in Humans

  • Phase I – Healthy adult volunteers
      • Evaluation of safety, Pharmacokinetics (PK), side effects???
  • Phase II - Patients
      • Evaluation of efficacy, safety, PK, and side effects
      • Double-blind placebo controlled
  • Phase III – Specific patient subpopulations
      • Determine efficacy for specific indications
      • Large sample of specific patients (1,000)
      • Randomized double-blind placebo controlled
  • Phase IV – Post FDA Approval
      • Determine efficacy for specific indication
      • Determine drug utilization patterns and additional efficacy
      • Monitor rare, severe side effects/toxicity
slide16

Drug Nomenclature

  • Chemical name(化学名)- *Generic name (非专利名)
  • Trade name (商品名)

Chemical Name: 2-(4-isobutylphenyl)-propionic acid

Generic Name: ibuprofen(布洛芬)

Trade Names: Advil, Aches-N-Pain, Brufen,

Emodin, Haltran, Medipren,

Midol 200, Motrin, Nuprin,

Rufen, Trendar, Wal-Profen

*preclinical nomenclature = company abbrev-123456 (e.g. WAY-100635, MK-869)