NEVADA MPJE Correct Questions & 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