Biotechnology is the application of biological organisms, systems or process to manufacturing of pharmaceuticals. Source: EU Clinical Trials Register
Chemical Abstract Services (CAS) are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys. A service of the American Chemical Society that indexes and compiles abstracts of worldwide chemical literature called Chemical Abstracts. Source: EU Clinical …
Procedural advice on the provision of scientific recommendation on CAT (classification of advanced therapy medicinal products). Source: EU Clinical Trials Register
European conformity Marking: A mandatory European marking for products falling under one of the New Approach Directives (including medical devices, but excluding cosmetics, chemicals, pharmaceuticals, foodstuffs) to indicate conformity with the health and safety requirements set out in European Directive. …
An eight digit unique numeric code assigned to a MedDRA term. The code is non-expressive and is intended to fulfil a data field in various electronic submission types. Source: EU Clinical Trials Register
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study …
An investigational or marketed product (i.e. active control) or placebo, used as a reference in a clinical trial. Source: EU Clinical Trials Register
A regulatory agency in an EU Member State or for medical devices, a Competent Authority is the organization with the authority to act on behalf of the government of a Member State to ensure that all medical devices meet the …
The unit of measurement used for the concentration of the active substance. Source: EU Clinical Trials Register
In a controlled trial, the tested product is compared to a reference treatment. The reference treatment can be, for example, a placebo, a product known to be effective, a surgical procedure, or a different dose of the same product. Source: …