Pharmacy Practice - Exam 3 Questions and Answers

Pharmacy Practice - Exam 3 Questions and Answers Investigational New Drug (IND) - Answers-Drug/antibiotic/biologic used in a clinical investigation Drug is NOT marketed Label must bear the statement: "Caution: New Drug - Limited by Federal (or United States) law to investigational use." .Investigational New Drug Application (INDA) - Answers-Submission to FDA containing chemical info, preclinical data, and detailed description of planned clinical trials 30 days after the FDA acknowleges receipt of this, clinical trials can be initiated .FDA (Food and Drug Administration) - Answers-Responsible for ensuring safety and efficacy of ALL food, drugs, cosmetics, and drug devices on the market .Drug Master File (DMF) - Answers-References on file with the FDA that contain information on the drug CMC - Chemistry, manufacturing, and controls of the drug to be included in the filing of an IND .Institutional Review Board (IRB) - Answers-Committee of reviewers evaluating the safety and ethical considerations of a clinical study protocol Evaluate research protocols and informed consent To ensure rights and welfare of patients - risks are minimal, informed consent obtained; expected risk to anticipated benefit ratio should be minimal Review ongoing research annually and evaluate adverse experiences .Orphan Drug (OD) - Answers-Used for treatment of rare disease (affecting 200,000) or revenues do not justify cost of research and development .Clinical Investigation - Answers-Any experiment in which a drug is administered or dispensed to one or more human subjects .Sponsor - Answers-Organization who takes responsibility for and initiates the clinical investigation .Clinical Safety Officer - Answers-This the sponsor's contact person with the FDA (usually MD) .Contract Research Organization - Answers-Group that assumes one or more of the obligations of the sponsor .Drug Importation Act (1848) - Answers-Prohibited the importation of unsafe or adulterated drugs at key ports of entry .Biologics Controls Act of 1902 - Answers-Mandated annual licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and similar products in interstate commerce .Pure Food and Drugs Act (1906) - Answers-Prohibited interstate commerce of adulterated or misbranded drugs Required labeling of selected dangerous and addictive substances Identified United States Pharmacopoeia and the National Formulary as official standards fro drugs .Food, Drug, and Cosmetic Act (1938) - Answers-Required that firms prove evidence of safety to the FDA before marketing Placed drug advertising under the jurisdiction of the Federal Trade Commission .Durham-Humphrey Amendment (1951) - Answers-Amended the FD&C Act of 1938 to statutorily differentiate prescription and nonprescription drugs .Kefauver-Harris Drug Amendment (1962) - Answers-Established the requirement for drug firms to demonstrate efficacy as well as safety .Orphan Drug Act (1983) - Answers-Established grants, federal assistance for research, and tax incentives to develop drugs targeted for a patient population of less than 200,000 .Drug Approval Process - Answers-Pre-clinical studies INDA submission/acceptance Clinical investigation NDA submission/acceptance FDA approval Drug Marketed .Study Protocol - Answers-Purpose: 1) Outlines objectives of a clinical research trial 2) Must be approved by IRB 3) Clear and attainable scientific goals Parts: 1) Title page 2) Table of contents 3) Introduction and scientific background 4) Objectives 5) Patient eligibility criteria 6) Procedure Also: tx plan, criteria for response assessment, procedure in event of response, no response, or toxicity; dose modification, statistics, references, records to be kept, copy of informed consent .Informed Consent - Answers-Purpose: to educate patients on the risk of each therapy Provides information about tx and/or drug in laymans terms: 1) objectives 2) risks and benefits 3) alternative txs available 4) patient is encouraged to read and ask questions .Preclinical Drug Studies - Answers-In vitro or animal studies Acquisition of new agent Screening for new activity Formulation and production Toxicology (in at least 2 species of animals) studies completed Lab and animal studies that assess safety and biologic activity various model systems An IND application is drafted and submitted to the FDA - general plan of investigation, drug info, protocol, manufacturing, and control of drug .Phase I Clinical Drug Trials - Answers-Usually last 6-12 months Initial introduction of an IND into humans Typically 20-100 healthy volunteers Goal is to garner information on the pharmacokinetic and pharmacodynamic properties of the investigational drug to design a well-controlled and robust phase II trial .Phase II Clinical Drug Trials - Answers-Pilot clinical trials Controlled clinical trials conducted in no more than several hundred subjects Goal: evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under investigation and to determine the common short-term adverse effects and risks associated with the drug .Phase III Clinical Drug Trials - Answers-Administration of investigational drug to range of several hundred to several thousand patient subjects in different clinical setttings Determine its safety, efficacy, and appropriate dosage Goal: gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling Step before the sponsor's submitting an NDA to the FDA for approval to market the drug Once NDA is submitted, it is classified with a code that reflects both the type of drug being submitted and its intended uses Letter code describes the review priority of the drug - S = standard review, P=priority review .New Drug Application (NDA) Submission - Answers-Components: 1) Preclinical data 2) Clinical data 3) Manufacturing method 4) Product quality assurance