What is compassionate use? The term ‘compassionate use’ refers to special programmes set up to make unauthorised medicines available to patients. In particular, this may be a way of...
Note: This webinar took place on 28 June 2018. You can find a video recording and the presentations used during the webinar below. Webinar introduction Community advisory boards (CAB) are an...
Bioavailability is the fraction (percentage) of an administered dose of unchanged drug that reaches the blood stream (systemic circulation). Bioavailability varies between different pharmaceutical ingredients and mode of administration.
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be...
Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatments participants have received during a clinical trial.
EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in...
HTA bodies carry out clinical effectiveness assessments, in which new technologies are compared with the standard of care and other existing treatments.
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest,...
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