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General toxicity studies

Non-clinical toxicity studies investigate the safety profile of a medicine. Candidate compounds must undergo many different toxicity studies before they are first administered in clinical trials or receive marketing...

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Data collection in clinical trials

There are several forms of data collection in clinical trials, including electronic methods and Patient Reported Outcomes (PROs). All forms of data collection must adhere to Good Clinical Practice...

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Clinical study results: Publication

After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.

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Medicines regulation in Europe

Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations...

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Patients Involved – An ultra orphan disease

A collaboration of Genzyme, International Pompe Association (IPA); UK, Dutch, and US Pompe patient organisations, Erasmus Medical Center and Duke University to establish appropriate measures to ensure the data...

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