The data management process involves system setup, CRF/database creation, data collection/entry, validation/querying, medical coding, handling external data, blind reviews, database locking, data export/exchange, and archiving documentation.

Run in period and washout period are two commonly used concepts in clinical trials.

To eliminate variability in lab results due to different instruments and technicians across centers, all blood or urine samples from the multicenter trial are analyzed and reported by a single lab.

Adverse event (AE) refers to any adverse event that may occur to the subject in the clinical trial and may be related to the trial treatment and trial treatment.

PDUFA, the Prescription Drug User Fee Act of 1992, mandates the FDA to charge firms for drug and biologic application reviews. Revenue supports faster safety and efficacy assessments.

"Sustained-release preparations" are formulations designed for prolonged drug release to maintain enduring effectiveness, often through a first-order release rate.

Patent licenses are divided into the following five basic types.

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements.

Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes.

While both SPCs and PTEs serve the purpose of extending patent protection for pharmaceutical or plant protection products, there are several key differences to consider.

Passive and active drug delivery are two distinct approaches used to improve the targeted delivery of drugs within the body.

Drug interactions occur when two or more medications are taken together and the effect is different than if they were taken separately.