New molecular entity nme Study guides, Class notes & Summaries

RAC Prep Drugs with Latest Questions and Expert Answers drug ANSWER An article intended for use in the diagnosis, cure mitigation treatment or prevention of disease in man new drug ANSWER -New use of a drug substance or component (active ingredient, excipient, carrier, coating). -New use of a combination of approved drugs -Change in proportion of ingredients in a combination drug -New intended use of a drug -Change in dosage, method or duration of administration or application activ...

drug - An article intended for use in the diagnosis, cure mitigation treatment or prevention of disease in man new drug - -New use of a drug substance or component (active ingredient, excipient, carrier, coating). -New use of a combination of approved drugs -Change in proportion of ingredients in a combination drug -New intended use of a drug -Change in dosage, method or duration of administration or application active moiety - Central, active part of a molecule or ion responsible for th...

IND - ANSWER-Investigational New Drug GLP - ANSWER-Good Laboratory Practices GMP - ANSWER-Good Manufacturing Practices GCP - ANSWER-Good Clinical Practice CMC - ANSWER-Chemical manufacturing and control cGMP - ANSWER-current good manufacturing practices MTD - ANSWER-maximally tolerated dose IB - ANSWER-Investigator's Brochure AE / SAE - ANSWER-Adverse Events / Severe Adverse Events RDT - ANSWER-Random discontinuation trial DSMB - ANSWER-Data Safety Monitoring Board...