ETX 30-6

ETX 30-6 - Environmental Toxicology 30 Topic: Regulation of...

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Environmental Toxicology 30 Chemical Use and Abuse Topic: Regulation of Chemicals I. Drug Development a. Cost of drug development i. $802 Million 1. Tufts Center for Drug Development, 2003 ii. $1.7 Billion 1. Chemical and Engineering News, 2003 iii. $1 Billon 1. Healthcare Economist, 2010 iv. Can take up to 12 years b. Drug development: role of Food and Drug Administration (FDA) i. Truth in labeling 1. 1930s Massengil developed a new liquid preparation of an antibiotic sulfonamide primarily for marketing purposes. 2. Bu the drug does not go easily into water, alcohol or other pharmaceutical solvent. 3. Was soluble in diethylene glycol (antifreeze) and after added color and raspberry flavor went on the market. 4. Nobody thought about safety and toxicity testing was not required. 5. Diethylene glycol is a kidney toxicant and over 100 people died. 6. The company initially would not divulge the use of diethylene glycol. ii. Toxicity 1. 1938: Congress enacted Food, Drug and Cosmetic Act requiring the testing of new drugs for safety prior to marketing. 2. Still no proof of efficacy required. 3. 1958: Act amended with the Delaney clause which prohibited potentially cancer causing food additives. iii. Determination of efficacy 1. 1962: Before a drug could go to market it had to be proved both safe and efficacious. 2. Requires pharmacological and toxicological research in animals before a drug can be tested in humans. 3. Data from these preclinical studies are submitted for approval as an investigational new drug (IND) before clinical studies can be initiated. II. FDA Regulation of Drugs a. Preclinical testing i. In vitro and in vivo animal testing ii. Long and short term studies iii. 2 species- rodent and non-rodent iv. Pharmacokinetics questions 1. How much of the drug is absorbed into the blood? 2.
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ETX 30-6 - Environmental Toxicology 30 Topic: Regulation of...

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