Pharmacology is the study of how a medicine works, how the body responds to it, and the changes that occur over time. There are two key areas of pharmacology:...
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...
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...
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
A medicine is commonly defined as a drug or preparation that can treat or prevent disease. Medicines must be delivered into the body, where they are then distributed to...
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.
During lead generation, many molecules are tested for target interaction. These may then need to be altered, or optimised, in order to improve their effect on the target.
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
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...
