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TCC Pharm 1
| Question | Answer |
|---|---|
| What is urtecaria - itching, edemia-swelling, irregular breathing, antiphilactic shock | True drug allergy |
| Chemical name | determined by chemical structure |
| Trade name aka: proprietary name | determined by pharmaceutical company that discovered drug Name is Capitalized |
| Generic Name | becomes the official name of the drug. Each drug only has one. Name is NOT capitalized |
| When does patent on original drug expire? | 17 years |
| The FDA requires | that the active ingredient of the generic product enter the bloodstream at the same rate as the trade name product. |
| Chemical equivalent | when two formulations of a drug meet the chemical and physical standards |
| Biologically equivalent | if the two formulations produce similar concentrations of the drug in the blood and tissues |
| Therapuetically equivalent | if the two formulations prove to have an equal thera puetic effect in a clinical trial |
| Before generic drugs are marketed they must be | biologically equivalent which would make them therapuetically equivalent. |
| A drug can be chemically equivalent but not | biologically or therapeutically equivalent |
| FDA food and drug administration | Approval given in US for safety and effectiveness Rx and OTC Regulates labeling and advertising of RX DRUGS |
| FTC federal trade commision | Prohibits false advertising of food OTC drugs and cosmetics |
| DEA drug enforcement administration | regulates the manufacture and distribution of substances that have a potential for abuse opioids(narcotics)stimulants sedatives |
| OBRA Omnibus Budget Reconciliation Act | mandates pharmacists must provide patient counseling |
| Adverse reaction of side affect can be | fainting / syncope |
| Pt. who is allergic to valium can not have | diazepam or other trade name. |
| Human studies Phase 1 | primarily determines safety. |
| Human studies Phase 2 main purpose | is to check effectiveness. |
| Human Studies Phase 3 | the dosage is determined. |
| Human studies Phase 4 | involves postmarketing surveillance. Drugs can be taken off the market @ this stage. |
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