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.

B

Best-in-class drugs

A best-in-class drug refers to a follow-on drug that is considered superior within an established mechanism of action, providing improved efficacy, safety, patient compliance, and/or reducing the costs or burden of treatment when compared to a first-in-class (FIC) or previous best-in-class (BIC) drug. These drugs may become the new gold standard in their therapeutic area by demonstrating therapeutic superiority without compromising safety or quality of life, making them the preferred choice of treatment