DDS Exam 1 Questions With 100% Correct Answers

DDS Exam 1 Questions With 100% Correct Answers define indication specific use for a drug -its labeled use [FDA approved] 2 other names for psuedopolymorphs hydrates or solvates 2 requirements for FDA approval to market a drug product -show safety and efficacy -shop process control and validation (will they work the same every time) 2 main stages of drug development process are preclinical and clinical (study done in humans) 4 steps of drug discovery 1. "target" identification and validation 2. "hit" identification and screening (molecule that interacts with targets) 3. "lead" identification and optimization (prototype chemical that has desired biological or pharmacological activity) 4. "candidate" preclinical then clinical drug development (lead that is most suited for further investigation) explain pharmacodynamics investigates biochemical and physiological effects of drugs, including their mechanism of action explain toxicology investigates potential for adverse effects -short term (for single dose or short-term multiple dose effects) -long term (chronic studies) What does ADME stand for in pharmacokinetics? absorption, distribution, metabolism, excretion What must be filed with FDA before human testing Investigational New Drug Application -comprehensive application detailing all aspects of pre-clinical studies and plan for clinical studies Purpose of 30-day waiting period -ensure research subjects are not exposed to unreasonable risks -IND is reviewed by experts Possible outcomes of 30 day review -safe to proceed (trial will begin) -clinical hold (proposed trial is not safe to proceed, FDA will explain what must be done to reverse the hold) -partial clinical hold (may proceed under restrictions described in letter of sponsor) Purpose of Phase 1-3 drug trials 1: safety and dosage 2: effectiveness and short term safety 3: effectiveness and long term safety Patient Type of Phase 1-3 drug trials 1: healthy volunteers (metabolism and excretion studies) 2: patients suffering from indicated condition 3: patients suffering from indicated condition # of volunteers of Phase 1-3 drug trials 1: 20-100 2: 100-500 3: Length of Phase 1-3 drug trials 1: 1.5 years 2: 2 years 3: 3.5 years % of drugs successfully completing Phase 1-3 drug trials 1: 67% 2: 45% 3: 5-10% What is the NDA -FDA drug application that must be approved -integrates all data with 1000+ pages and can take up to 10 months to sort through Quality standards that must be in line with during inspection portion of drug approval process -comply with application quality standards -comply with quality standards in FDA's Current Good Manufacturing Practice Standards 2 possible results of FDA's decision in drug development -approval letter -complete response letter --outlines deficiencies and may recommend actions needed What happens in phase 4 clinical studies learn more about drug's safety, efficacy, and cost effectiveness Adverse Reaction reporting can come from internal or external sources including -physicians -post-marketing studies -pharmacists define orphan drug -Drug designed for a very small population with a rare disease -no expectation that costs of research and development for indication can be recovered by sales of product in US define rare disease disease that affects fewer than 200,000 peopple in US what is expanded access IND -for patients with life-threatening or severely debilitating illnesses where no satisfactory alternative exists --facilitates getting drugs to patients outside of a clinical trial What is the abbreviated new drug application -dose not require clinical studies except those relating to bioavailability Define bioavailability Drugs contain the same amount of the identical chemical compound and are absorbed at the same rate and to the same extent. 3 requirements for generic drug approval -pharmaceutically equivalent (same API, strength, dosage dorm and route) -bioequivalent (no clinically significant difference in bioavailability) -generic is expected to have same clinical effect and safety profile when properly administered what is the supplemental new drug application for 1. changes in labeling, method of synthesis, formulation, analytical standards, container, manufacturing facilities 2. new indication of drug explain fast track -serious condition and nonclinical or clinical data de