EMA Terms (5)

An analytical method published in an official pharmacopoeia (USP, Ph. Eur., JP) that serves as the recognized standard for testing a specific article.

A clinical trial where some or all trial activities take place at locations other than traditional research sites, often including patient homes.

Analytical testing to quantify bacterial endotoxins in parenteral drugs, medical devices, and other products where endotoxin presence could cause pyrogenic reaction.

The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

The lowest dose at which a biologic is anticipated to produce any pharmacologically meaningful effect in humans, used as the basis for first-in-human starting dose for high-risk products.