A patients involved case report on the Duchenne Parent Project collaborating with academia and industry to find a cure/treatment for Duchenne Muscular Dystrophy.
Patient advocates can be involved in early clinical development through partnerships and working relationships with regulatory authorities, ethics committees, investigators, and industry. They can provide input and play an...
Early clinical trials (Phase I and II) must establish above all that an investigational medicinal product is safe for humans, as well as to show that the medicine is...
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...
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...
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...
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,...
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...
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...
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...
