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...
An example of patients involved through patients and patient organisations providing input into a
Cushing’s disease clinical trial design. The consultation took place between Novartis and nurses from different teams...
A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric...
There are several types of clinical trial designs: randomised or non-randomised controlled trials, single or double blinded trials, and superiority or non-inferiority trials.
