TCC Pharm 1 Word Scramble
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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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