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[Technical implications on the quality standard of new drugs]
Eisei Shikenjo Hokoku. Bulletin of National Institute of Hygienic Sciences
|January 1, 1995
Abstract:
New guidelines on the establishment of quality specifications and analytical methods for a new drug application were notified from the Evaluation Division of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, on September, 1994. General policies as well as an impurity test, drug release, and the uniformity of dosage unit are discussed from the viewpoint of international harmonization and technical advancement.