nurs 180 week 1 ppt (correctly solved)

Pharmacotherapeutics correct answers application of drugs for the purpose of treating disease and the treatment of suffering when is a drug called a medication correct answers after it is administered Three Most Important Properties of an Ideal Drug correct answers effectiveness (most important) , safety, selectivity (Drug elicits only the response for which it is given) 1906: Federal Pure Food and Drug Act correct answers focused on product labeling 1938: The Food, Drug and Cosmetic Act correct answers first legislation to address drug safety: this set requirements for testing and review by the FDA 1962: Harris-Kefauver amendment to the Food, Drug and Cosmetic Act - correct answers -in response to the thalidomide tragedy -enforced effectiveness -first law to require proof of effectiveness before new drug could be marketed §1970: Controlled Substance act/ set correct answers -rules for the manufacture and distribution of drugs considered to have potential for abuse -One provision defined 5 categories known as schedules(Schedules I, II, III, IV and V) Four stages of FDA approval for new drug correct answers •Preclinical investigation •Clinical investigation •Review of new drug application (NDA) •Post marketing surveillance phase 1 approval correct answers test safety phase 2 approval correct answers test effectiveness phase 3 approval correct answers confirm safety and effectiveness phase 4 approval correct answers submit to fda then test for long term effects and additional uses preclinical investigation correct answers •Involves laboratory research •Tests done on cells and animals •Determines drug-dose range •Examines adverse effects •Results considered inconclusive clinical investigation is tested on who first correct answers •Tests on healthy humans first, then on those with the target ailment