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
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
