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Clinical Development Division
Consistent R&D activities including basic drug research, nonclinical, clinical studies and product lifecycle management

Drug Discovery Research Department conducts the evaluation of development candidates, screening of various pharmacological actions, elucidation of its mechanisms and synthesis of metabolites and degradation products for searching new candidates. And it also conducts the nonclinical studies(pharmacology, pharmacokinetics and toxicity assessment)related to a new drug application for early launch of developing products.
Pharmaceutical Research Department designs formulation to maximize the value of a product and evaluates efficacy using microorganisms to confirm effectiveness. For early launch, it carries out physicochemical studies and stability testing. It also establishes test procedures and acceptance criteria for CMC development.
Department of Project Management and Research Planning serves as a liaison among the related departments and divisions. Its jobs are management of ongoing R&D projects, information search around the R&D themes and other general management.
These three departments establish and maintain infrastructure that conforms to standards such as Good Laboratory Practice(GLP)and quality.
Furthermore, animal welfare is always taken into consideration when animal studies are conducted. Each department strives for more effective and safer pharmaceutical drug development to contribute to maintaining healthy lives of people. Clinical Development Department conducts clinical trials of the new drug candidates whose efficacy and safety were confirmed in nonclinical studies, under Good Clinical Practice(GCP)- from phase I to phase III studies - to confirm their efficacy and safety in humans. Then, it obtains manufacturing and marketing approval of new drugs.

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