臨床薬実践の試み（第３版） Good practice of clinical drug trials （3rd, rev. and exp. ed. 2004. VIII, 271 p. w. figs. 25 cm）

臨床薬実践の試み（第３版）<br>Good practice of clinical drug trials （3rd, rev. and exp. ed. 2004. VIII, 271 p. w. figs. 25 cm）

臨床薬実践の試み（第３版）
Good practice of clinical drug trials （3rd, rev. and exp. ed. 2004. VIII, 271 p. w. figs. 25 cm）

Spriet, Alain/ Dupin-Spriet, Therese

KARGER（2004発売）

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製本 Hardcover:ハードカバー版／ページ数 274 p.
商品コード 9783805577243

Full Description

This new edition of 'Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: rationale for each rule presented; safety of data in clinical trials; protection of personal data; conflicts of interest; and, measures to be taken in case of suspected fraud.