Pharmaceutical industry - Drug Development, Regulation, Research

pharmaceutical industry

Table of Contents

Introduction
History
- The origin of medicines
  - Medicines of ancient civilizations
  - Pharmaceutical science in the 16th and 17th centuries
- Isolation and synthesis of compounds
- The development of anti-infective agents
  - Discovery of antiseptics and vaccines
  - Improvement in drug administration
- Drug development in the 19th and 20th centuries
  - New classes of pharmaceuticals
  - Transitions in drug discovery
- Establishing the fight against infectious disease
  - Early efforts in the development of anti-infective drugs
  - Discovery of penicillin
- Discovery and development of hormones and vitamins
  - Isolation of insulin
  - Identification of vitamins
- Emergence of modern diseases and treatment
  - Hypertension
  - Early progress in cancer drug development
  - Pharmaceutical industry in the modern era
Drug discovery and development
- Drug development process
  - Research and discovery
  - Contribution of scientific knowledge to drug discovery
- Drug screening
  - Sources of compounds
  - Lead chemical identification
    - Lead compounds from natural products
    - Taxol and the Pacific yew
- Strategies for drug design and production
  - Structure-activity relationship
  - Computer-aided design of drugs
  - Combinatorial chemistry
  - Synthetic human proteins
Drug regulation and approval
- Regulation by government agencies
  - Public influence on drug regulation
  - Objectives and organization of drug regulatory agencies
- Drug approval processes
  - Drug applications
    - The Investigational New Drug application
    - The New Drug Application
  - Safety testing in animals
    - Toxicity tests
    - Teratogenicity and mutagenicity tests
  - Biopharmaceutical studies
    - Pharmacokinetic investigation
    - Dosage form development
      Tablets
      Capsules
      Other solid dosage forms
      Liquid dosage forms
      Semisolid dosage forms
      Specialized dosage forms
      Modified-release dosage forms
      Parenteral dosage forms
      Radiopharmaceuticals
Obstacles in drug development
- Adverse reactions
- Postmarketing adverse drug events
- Drug interactions
- Drug patents

References & Edit History Related Topics

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Adverse drug events are unanticipated or unwanted effects of drugs. In general, adverse drug reactions are of two types, dose-dependent and dose-independent. When any drug is administered in sufficiently high dose, many individuals will experience a dose-dependent drug reaction. For example, if a person being treated for high blood pressure (hypertension) accidentally takes a drug dose severalfold higher than prescribed, this person will probably experience low blood pressure (hypotension), which could result in light-headedness and fainting. Other dose-dependent drug reactions occur because of biological variability. For a variety of reasons, including heredity, coexisting diseases, and age, different individuals can require ...(100 of 13439 words)

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