An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. A drug for the treatment of a rare disease (affecting fewer than …
Marketing Authorisation Holder (MAH). The company named on the Marketing Authorisation for a specific product in a particular country. Source: EU Clinical Trials Register
A medicinal product derived from human tissue such as blood or plasma. Source: EU Clinical Trials Register
Conducting the first dose in human phase I clinical trial. Source: EU Clinical Trials Register
The title as specified in the study protocol and other documents submitted as part of the Clinical Trial Application. Source: EU Clinical Trials Register
The point of contact for further information on the trial (e.g. Clinical Trial Information Desk). Source: EU Clinical Trials Register
Product aimed at the transfer of a prophylactic, diagnostic or therapeutic gene to human and its subsequent expression in vivo. Source: EU Clinical Trials Register
Any medicinal product exclusively containing as active ingredients one or more herbal substances or preparations. Adapted from Dir 83/2001. Source: EU Clinical Trials Register
Homeopathic medicinal products are medicinal products based on a dilute solution of raw material from the plant, animal or mineral kingdoms. Source: EU Clinical Trials Register
Human pharmacology (Phase I) trials are the first stage of testing in human subjects, generally comprising a small group of healthy volunteers. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Source: …