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Table of Contents
CONTENTS
FOREWORD
(1) PMSB Director-General Notification No. 739 dated August 11, 1998: "On the Handling of Clinical Data on Pharmaceuticals Generated in Foreign Countries"/ 1
(2) PMSB／ELD Notification No. 672 dated August 11, 1998: "On Ethnic Factors in the Acceptability of Foreign Clinical Data"/ 3
(3) ICH E5 (Step 5): Guideline for Ethnic Factors in the Acceptability of Foreign Clinical Data/ 4
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- Material Type
- 図書
- ISBN
- 4-8408-0526-1
- Volume
- 1999
- Author/Editor
- Review Assessing Group, Evaluation and Licensing Division, Pharmaceuticals and Medical Safety Bureau, Japanese Ministry of Health and Welfare [監修]
- Author Heading
- 厚生省医薬安全局 コウセイショウ イヤク アンゼンキョク ( 00661679 )Authorities
- Publication, Distribution, etc.
- Publication Date
- c1999
- Publication Date (W3CDTF)
- 1999
- Extent
- 65p