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We are so-called "drug discovery" company to play mainly the first half role of research and development process of pharmaceutical drugs.
As for the research and development process of drug products, following steps are required in general.
First, compounds appropriate for a theme are explored (exploratory study):
obtained/discovered compounds are improved for better substance (optimization);
verification in animal models (nonclinical study) is conducted;
after that, IND application to regulatory authorities in each applicable country (Ministry of Health, Labour and Welfare in Japan, and Food and Drug Administration in US) for the conduct of clinical studies is submitted;
examination in human subjects under supervision of the authority (clinical study) is conducted;
application to regulatory authority (NDA application) is submitted;
and then, the product is approved as a pharmaceutical drug to launch and distribute afterwards.
During above process, the first half part of activities (i.e., from exploratory study to clinical study) is called "Drug Discovery".
