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Pharm Terms ch2

Formulary first standard list of drugs and drug recipes used by pharmacists
Pharmacopoeia summarizes standard of drug purity, strength, and directions for synthesis
Excipients inactive ingredients
Black box warnings primary alerts for extreme adverse reactions
Preclincal investigation laboratory research testing on human and microbial cells
FDA's Critical Path Initiative effort to modernize the sciences to enhance the use of bioinformation to improve safety and effectiveness.
Clinical investigation second phase of drug testing - has three stages of of trials
Clinical phase trials longest part of drug approval process - perform tests on volunteers to determine adverse effects
New Drug Application (NDA) must be submitted before a drug is allowed to proceed
Investigational New Drug (IND) may be submitted for Phase I clinical trials when there are significant therapeutic benefits and safe for humans
New Drug Application (NDA) review third phase of drug approval process; trade name is finalized
Postmarketing surveillance final phase of drug approval process; purpose is to survey for harmful drug effects in a larger population
Dependence physiological or psychological need for a substance
Physical dependence altered physical condition when the drug is no longer available
Psychologically dependent intense desire to continue drug use
Controlled substance use is restricted by the Controlled Substance Act
Scheduled drugs 5 classifications according to their potential for abuse
Schedule I Drugs highest potential for abuse
Schedule V Drugs lowest potential for abuse
Teratogenic risk drugs that have potential to harm fetus; categories A, B, C, D, X
Category X Teratogenic drug poses most danger to fetus