Clinical trials (drug trials) investigate the effectiveness and safety of new drug on humans to obtain approval for its manufacture and sale. This is the final and most important stage in the new drug development process. It is self-evident that clinical trials are subject to the highest ethical and scientific standards. In this context, it is also important to test the possibilities of mitigating patient load in terms of drug administration frequency and other factors. Kyorin is actively engaged in clinical trials both in Japan and abroad. Moreover, we seek to conduct effective development through joint projects with other companies and the use of contract research organizations (CROs).
- CRO:Contract Research Organization
In clinical development work, it is important for other departments within a company and those with various external viewpoints such as doctors and clinical research coordinators (CRCs) to work together. Through repeated exchanges of opinions and coordination, the parties involved develop a plan for the clinical trials, select an institution and commence the clinical trials. To ensure that new drugs are introduced into medical practice as soon as possible, we focus on collecting accurate data and seek to speed up the process.
- CRC:Clinical Research Coordinator
| Phase | Major Trials | Details |
|---|---|---|
| Phase I | Clinical Pharmacology Trial |
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| Phase II | Exploratory Trial |
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| Phase III | Verification Trial |
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| Phase IV | Therapeutic Trial |
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Pharmaceuticals are released after clinical trials involving patients of limited ages, complications and other attributes. However, in actual medical practice, those pharmaceuticals are used on patients with various backgrounds. Drug fostering research is the process of finding more effective and safer uses or new pharmacological effects for post-marketing pharmaceuticals, and enhancing their added value. By incorporating the information gained from drug fostering research, drugs which are easier to use can be developed. We contract with universities, research institutes and medical institutions to conduct basic tests and clinical trials to build up a scientific basis. The results are made public through scientific presentations or article contributions, and the information provided to those involved with medical treatment such as doctors and pharmacists.
To pharmaceutical companies, the fostering of existing drugs is just as important as the development of new ones. For the purpose of drug fostering, KYORIN Pharmaceutical has established the Drug Fostering Promotion Dept. as a dedicated section. The department investigates the possibilities for existing drugs such as Mucodyne and Uritos.
