Basic and clinical evaluation of new drugs, stages of drug development and pharmacology methods Exam Questions And Answers

Basic and clinical evaluation of new drugs, stages of drug development and pharmacology methods Exam Questions And Answers human subjects protection, safety and efficacy - answerwhats is the role of the FDA? human subjects protection - answerthis says that you cant test a new drug on a human without the FDA's permission Discovery , characterization, human testing, marketing - answerwhat are the 4 main stages of drug development drug discovery / synthesis - answermodification , random screening , rational drug design, and biotechnology are involved with which phase? characterization - answerin this phase you determine a pharmacological profile , animal research is done, and the development of a lead compounds how the drug moves throughout the body - answerpharmacokinetics how the drug works - answerpharmacodynamics IND - answerin order to begin phase 3: human testing, you must file what with the FDA? phase 1 - answerhuman testing which phase has to do with dose response for adverse and toxic effects people without anxiety - answerin phase 1 of human testing , if they are trying to create a drug for someone with anxiety, what kind of people do they want in the experiment? phase 2 - answerin this phase of human trials they do a case study on whether the drug works and recruit people with interest or need for the drug