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Development

Development

TEAMS that Change Tomorrow

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Realizing the ideal balance between effectiveness and safety

Targeting safe, effective drugs
Candidate compounds for new drugs found during the drug discovery research process are subjected to detailed examination to confirm their safety and efficacy - the two qualities that are of paramount importance. To obtain approval for sale of the new drug, the pharmaceutical company must conduct pre-clinical studies on candidate compound that comply with good laboratory practice (GLP) standards, as well as clinical studies that comply with good clinical practice (GCP). Assuming the desired results are obtained from those studies, the pharmaceutical company will proceed to application for approval of sale of the new drug.
Specifically, a pharmaceutical company makes every effort to evaluate and estimate the safety and efficacy of a drug candidate during pre-clinical studies. If the drug candidate proceeds to clinical trials, these properties are then further tested on human subjects.
Clinical trials are generally divided into three phases. In Phase I, the drug candidates are tested for safety by means of administration to normal healthy subjects. In Phase II, testing for both safety and efficacy is conducted on a limited number of patients suffering from the target disease. At the same time, confirmation is obtained regarding the most appropriate dosage and method of administration. Finally, in Phase III, tests are conducted on a large number of patients to confirm the safety and efficacy of the drug.

At Astellas, we seek to provide patients with the drugs they need as soon as we can. Through close collaboration between our R&D units in Japan, the United States, and Europe, we enable the sharing of data on clinical trials conducted in all these areas, which helps speed up the new drug application process and realize an integrated development system on a global scale.


Notes:

1. GLP:good laboratory practice

2. GCP:good clinical practice

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