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8 Cards in this Set
- Front
- Back
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Investigational new drug and New Drug Application
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IND and NDA
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PhRMA
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Pharmaceutical Research and Manufacturers Association
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Institutional Review Board
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IRB
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DTC
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Direct-to-consumer (advertising)
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Federal Drug Administration (FDA)
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• Premarketing clearance of all new drug products
• Regulation of all labeling and advertising of Rx products • Regulation of manufacturing • Regulation of bioequivalence standards • Postmarketing surveillance |
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Pink Sheet
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Since 1939, this “Bible” of the prescription pharmaceutical industry has provided expert, in-depth analysis of regulatory, legislative, legal and business developments shaping the industry.
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pre-clinical phase
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n this clinical phase, studies are done in-vitro and in-vivo to obtain efficacy, toxicity, and pharmacokinetic information. This is done to determine whether or not the drug candidate is worth developing as an investigation new drug (IND)
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Orphan Drug Act
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This Act is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven years.
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