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TCC Pharm 1

QuestionAnswer
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.
Created by: 10454099
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