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DRUG DISCOVERY ACRONYMS - FINAL EXAM QUESTIONS AND ANSWERS

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DRUG DISCOVERY ACRONYMS - FINAL EXAM QUESTIONS AND ANSWERS

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DISCOVERY LAB
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DISCOVERY LAB

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DRUG DISCOVERY ACRONYMS - FINAL
EXAM QUESTIONS AND ANSWERS
RDT - ANSWER-Random discontinuation trial

DSMB - ANSWER-Data Safety Monitoring Board

NDA - ANSWER-New Drug Application

SPA - ANSWER-Specialized Protocol Assessment

PDUFA - ANSWER-Prescription Drug User Fee Act

NME - ANSWER-new molecular entity

ANDA - ANSWER-abbreviated new drug application

OOPD - ANSWER-Office of Orphan Product Development

GAIN - ANSWER-generating antibiotic incentives now

OTC - ANSWER-over the counter

GRASE - ANSWER-generally regarded as safe and effective

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

CDER - ANSWER-Center for Drug Evaluation and Research
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