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Contents contributed and discussions participated by marthamck

marthamck

How Drugs are Developed and Approved - 0 views

  • sure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.CDER is the largest of FDA's five centers.   It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews,  post-marketing risk assessment, and other highlights, please see the CDER Update: Improving Public Health Through Human Drugs1 The other four FDA centers have responsibility for medical and radiological devices, food, and cosmetics, biologics, and veterinary drugs. Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market.  It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labeling2. 
marthamck

The Pharmaceutical and Biotech Industries in the United States - 0 views

  • upports
  • The biopharmaceutical pipeline also has over 5,000 new medicines currently in development around the world with approximately 3,400 compounds currently being studied in the United States - more than in any other region around the world. 
marthamck

Historical Developments in the Pharmaceutical Industry - MIT - 0 views

  • Various ancient civilizations, from the Egyptians to the Chinese, developed their own unique systems for practicing medicine in the fields of herbalism, anatomy, public health, and clinical diagnostics1. Medicine was not practiced by physicians, but rather by the common people through observation and empiricism. The great Greek poet Homer described Egypt as a land where “the earth, the giver of grain, bears the greatest store of drugs” and where “every man is a physician”. Homer’s mythology does have some truth to it. In the famous Ebers papyrus, dating back to 1550 B.C., the ancient Egyptians describe more than 700 medicinal formulas; some were incantations and placebos that delivered their therapeutic effects through spiritual healing.
  • seventeenth century B.C.
  • not until the 19th century that the pharmaceutical industry evolved more systematic and scientific practices.
  • ...3 more annotations...
  • Louis Pasteur’s germ theory of disease and Robert Koch’s postulates3, which established criteria for establishing a causal relationship between a microbe and a disease, laid the foundation for infection theory and immunology. Paul Ehrlich, who is recognized as the founder of chemotherapy, studied the interaction between cells and synthetic dyes
  • modern research and development in drug discovery have remained largely unchanged since prehistoric times5,6.
  • For every 5,000 pharmaceutical compounds discovered, only one ever reaches a pharmacy.
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