Category - Clinical Development / Trials

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Patients Involved – Phase III Hepatitis C

A collaboration between Bristol-Myers Squibb (BMS) with FUNDHEPA (patient organisation) to give more patients the opportunity to receive an innovative treatment for Hepatitis C through the participation in a...

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Phase II Trials

In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine...

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Patients Involved – DevelopAKUre for AKU

An example of public-private partnership (DevelopAKUre) from diverse international groups in industry (Sobi), patient organisations (AKU Society and ALCAP), hospitals (Royal Liverpool, Hospital Necker, and National Institute of Rheumatic...

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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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Basics of Early Clinical Development

Early Clinical Development refers generally to the first studies of a medicine in humans – typically known as Phase I and Phase II trials. Studies in early clinical development...

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Good Practice – GxP

GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...

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Investigator’s Brochure

The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...

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