LEXICON
No.97 January 9, 2012

Exploratory study
探索的試験
Confirmatory study
検証的試験
Superiority study
優越性試験
Non-inferiority study
非劣性試験
Equivalence study
同等性試験
Bioequivalence study
生物学的同等性試験
Parallel-group comparative study
併行群間比較試験
Active placebo-controlled study
実薬対照試験

Clinical studies conducted to explore the characteristics of drugs (investigational drugs: 治験薬) are called exploratory clinical studies (探索的試験). PII clinical trials, which are conducted for preliminary evaluation of the safety, efficacy and pharmacokinetic profile (薬物動態) in a limited number of...

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