PubMed · 7717711
[Phase II study].
Abstract
It is 4 years since the Ministry of Health and Welfare of Japan introduced "The Guidelines on Clinical Evaluation for Anti-tumor Drugs" in February 1991. From the stand point that I have conducted several clinical studies on new anti-tumor drugs according to the Guidelines, this review pointed out some practical problems in the process to develop Phase II study based on the Guidelines.
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H Niitani. 1995. [Phase II study].. https://pubmed.ncbi.nlm.nih.gov/7717711/
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