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Present status of clinical pharmacology and of regulatory requirements for preclinical and clinical evaluation of new drugs in Japan
Author(s) -
Ishizaki Takashi,
Sugita Minoru
Publication year - 1974
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1974163part2577
Subject(s) - clinical pharmacology , regulatory science , medicine , drug development , pharmacology , public health , engineering ethics , drug , risk analysis (engineering) , engineering , pathology
The present status of regulatory requirements for preclinical and clinical evaluation of new drugs in Japan is discussed. The issue of the necessity for clinical pharmacology has been increasingly raised in Japan. It is emphasized that the public problem of the “drug explosion or pollution” of the past quarter‐century must be overcome by national or international cooperation on a basis of medicosocial responsibilities. Finally, clinical pharmacology units with an independent academic affiliation are needed in the near future. This hopefully, will facilitate and hasten the development of additional scientific methodology for the evaluation of drugs in man and will contribute to the public health.