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Pharm. Chapter 3
Drug Regulation, Development, Names, and Information
| Question | Answer |
|---|---|
| First legislation to regulate drug safety passed in 1938 was the: | The Food, Drug, and Cosmetic Act |
| First American law to regulate drugs was: | Federal Pure Food and Drug Act of 1906 |
| Phase I drug trials are usually conducted in _________ whereas Phase II and Phase III trials are tested in __________ | -Normal Volunteers-Patients |
| This law was created in response to the thalidomide tradgedy that occured in Europe in the early 1960s: | Harris-Kefauver Amendments |
| Drugs that can be purchased without a prescription are called: | Over-The-Counter Drugs (OTC) |
| Under conditions of the Controlled Substance Act, Schedule I drugs: | Have no accepted medical use in the U.S. and are deemed to have a high potential for abuse |
| The most reliable way to objectively assess drug therapies is: | Randomized Controlled Trials (RCTs) |
| A rare bith defect characterized by the gross malformation or complete absense of armas or legs due to pregnant women taking thalidomide | Phocomelia |
| In the U.S., the estiamted cost of developing a new drug can exceed: | $800 million |
| The _______ constitutes a description of a drug using the nomenclature of chemistry. | Chemical Name |
| The ______ is assigned by the u.S. Adopted Names Council. | Generic Name |
| The ______, _____, or ________ are names udner which a drug is marketed. | Trade Names, Proprietary Names, or Brand Names |
Created by:
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