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 focus on the safety and tolerability of the new medicine. They also try to show that the medicine can have the intended effect.
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 authorisation.
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 administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.
When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the candidate medicine before adequate reproduction toxicity data are available.
A rigorous non-clinical programme must be completed before a medicine may be tested in humans for the first time in Phase I clincial trials.
Clinical trial results are statistically analysed in terms of demographics, efficacy, and safety. Different types of clinical trial may warrant different interpretations of trial results.
The animal models used in non-clinical trials are carefully selected, taking various factors into consideration.
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and investigate other possible indications that the medicine might treat.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III studies are the largest, most complicated, and most expensive part of the medicines development process, and nearly 50% of medicines that enter this phase will fail.
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.