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.
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...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
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...
Some groups within the general population of a clinical study may require special study, due to the particular risks, benefits, or treatment requirements associated with them
During the target selection step of the medicines development process, scientists choose which abnormal process to focus on and correct in order to treat an illness.
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.
Human medical research is conducted according to strict principles of ethics. These principles have been developed over time, in reaction to various events in human history, and continue to...
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.
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