The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative...
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes...
Biomarkers are indicators used in medical research to measure biological processes, disease processes, and responses to treatment. The use of biomarkers can improve the process of medicines development and...
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
The processes of patient involvement in industry medicines research and development have evolved, but the evolution of frameworks, mechanisms, metrics and processes happens individually without much alignment and sharing.
Participants of clinical trials have rights that are protected by law, and they also have specific responsibilities. Participants' organisations have close relationships with the patients in a clinical trial...
Authors: Oyiza Momoh, Susan W. Burriss, Anya Harry, Kay Warner The importance of inclusion and diversity in clinical trials It is important that people...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
