The Japanese perspective regarding regulatory concerns for biotechnology drugs and their scientific basis.
Hayakawa
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National Institute of Hygienic Sciences, Tokyo, Japan.
D000818:Animals; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000592:standards; D004353:Drug Evaluation, Preclinical / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004355:Drug Stability; D006801:Humans; D007564:Japan; D015203:Reproducibility of Results