NEVADA MPJE questions with correct answers

Laws vs. Regulations - Answer laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process - Answer 1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval -- begin Phase 1 study, Phase 2, then Phase 3 4) file a new drug application (NDA) or biologic license application (BLA) to FDA 5) If drug approved, phase 4 study (post-marketing surveillance) Phase 1 study - Answer assesses safety and adverse effects, as well as PK and PD profile. Small number of healthy subjects (~20-80) Phase 2 study - Answer focuses on safety and efficacy. subjects have the indicated condition (~35-100). dose ranging analyzed to determine optimum dose Phase 3 study - Answer determines efficacy for treating the condition compared to a placebo or gold-standard treatment. larger number of patients (~300-3000) Phase 4 study - Answer (post-marketing surveillance). conducted after the drug is approved and released for use. can be requested by the FDA or initiated by the manufacturer. can be used to monitor special populations or long-term effects of drug exposure FDA Drug Approval Time - Answer - the NDA or BLA is evaluated by the FDA