PC707 Mod 1 Questions and Answers with complete

Phase 1 - Evaluate safety, 40-50 healthy volunteers Phase 2 - Evaluate efficacy, 10-100 patients Phase 3 - Statistical analysis of safety & efficacy, double blinded RCT Phase 4 - post marketing surveillance Absorption - The movement of a drug from the site of administration into circulation Bioavailability - Amount of ACTIVE drug that reaches systemic circulation Distribution - The movement of a drug form systemic circulation to the site of action Protein binding - Drugs are inactive when bound, free circulating drug is available for use Agonist - Drug that activates it's receptor Antagonist - Deactivates receptor/ prevents receptor activation Metabolism - Enzymatic alteration of a drug Induction - Drugs which increase rate of metabolism Decreases AUC Drug may not reach therapeutic level Inhibitors - Drugs that decrease the rate of metabolism Increased AUCDrug may become toxic/ more severe adverse effects Prodrug - Drug which is inactive until it is metabolized Able to cross BBB prior to activation Hepatic first pass effect - Rapid inactivation of drug when given PO Drug may not reach therapeutic level Consider parenteral administration Half life - Time required for drug to decrease by 50% in circulation Factors affecting excretion - pH ionization Competition for tubular transport Age Therapeutic drug level - Systemic concentration of drug between minimum effective concentration (MEC) and toxic concentration