TY - CHAP M1 - Book, Section TI - Investigational Drugs A1 - Grilley, Bambi A2 - Malone, Patrick M. A2 - Malone, Meghan J. A2 - Park, Sharon K. Y1 - 2018 N1 - T2 - Drug Information: A Guide for Pharmacists, 6e AB - After completing this chapter, the reader will be able toList the major legislative acts that led to the current system of drug evaluation, approval, and regulation used in the United States.List the steps in the drug approval process.List the components of an investigational new drug (IND) application.Recognize the difference between a commercial IND, treatment IND, an emergency use IND, and an individual investigator IND.Define orphan drug status and list the advantages of classifying a drug as an orphan drug.List all of the requirements (as specified by the Office of Human Research Protections [OHRP]) for an Institutional Review Board (IRB).Prepare appropriate protocol assessments for use by the IRB or other review committees when they evaluate new human subject protocols.Describe the type of support that is necessary for clinical research, including (but not limited to): ordering drug supplies for ongoing clinical trials;maintaining drug accountability records as required by the Food and Drug Administration (FDA);preparing drug and protocol data sheets for use by health care personnel in the hospital;preparing pharmacy budgets for sponsored clinical research;aiding investigators in designing and conducting clinical trials in their institution;assisting investigators in initiating and conducting clinical trials (including emergency use INDs). SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1151746582 ER -