New molecular entity nme Study guides, Class notes & Summaries
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RAC Prep Drugs with Latest Questions and Expert Answers
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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...
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RAC Prep Drugs Questions & Answers Rated 100% Correct!!
- Exam (elaborations) • 16 pages • 2024
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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...
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Drug Discovery Acronyms - Final Exam Questions and Answers
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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...
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