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Bioavailability and bioequivalence

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.

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The predictive value of non-clinical testing

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...

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EudraVigilance

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...

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Phase I Trials

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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