Click here to open the filter panel
#
510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
A
Adverse event
A
Analysis data model (ADaM)
A
Anonymization
A
Appropriate safeguards
A
Article 29 Working Party
A
Artificial Intelligence
A
Automated individual decision
A
Auxiliary medicinal product
B
Best-in-class drugs
B
Binding corporate rules (BCR)
B
Biometric data
B
Biotechnology
C
Central Laboatory
C
Central imaging
C
Chemistry, Manufacturing, and Controls (CMC)
Click a letter to view all its definitions
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

F

First-in-class drugs

A first-in-class drug refers to a pharmaceutical that utilizes a "new and unique mechanism of action" to treat a specific medical condition. These drugs represent novel approaches to addressing diseases and often provide innovative treatment options. They may introduce a completely new therapeutic approach or target previously unexplored pathways.