Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...
Biomarkers are indicators used in medical research to measure biological processes, disease processes, and responses to treatment. The use of biomarkers can improve the process of medicines development and...
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.
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...
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