Abbreviations and Terms in Clinical trials

Abbreviation Definition

ADR

Adverse Drug Reaction

Adverse Event

AUC

Area Under the Curve

BLA

Biologic Licensing Application

BUN

Blood Urea Nitrogen

CAP

College of American Pathologists

CBER

Center for Biologics Evaluation and Research (FDA)

CDER

Center for Drug Evaluation and Research (FDA)

CDRH

Center for Devices and Radiological Health (FDA)

CFR

Code of Federal Regulations

Confidence Interval

CLIA

Clinical Laboratory Improvements Amendments

Cmax

Maximum Plasma Concentration

Cmin

Minimum Plasma Concentration

CNT

Consented but Not Treated

Serum Creatinine