Current status of quality in Japanese clinical trials-Reference-Cited by-同舟云学术

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Current status of quality in Japanese clinical trials

Published:2005-08 Issue:4 Volume:26 Page:503-509
ISSN:1551-7144
Container-title:Contemporary Clinical Trials
language:en
Short-container-title:Contemporary Clinical Trials

Author:

Saito Kazuyuki,Kodama Yasuo,Ono Shunsuke,Mutoh Mizue,Kawashima Susumu,Fujimura Akio

Publisher

Elsevier BV

Subject

Pharmacology (medical),General Medicine

Reference21 articles.

1. Guideline for good clinical practice;International Conference on Harmonization (ICH) Harmonized tripartite guidelines (Step4),1996

2. MHLW Ordinance No.28. March 27, 1997.

3. MHLW Pharmaceutical Affairs Bureau Notification No.874. Guideline for good clinical practice (GCP). October 2, 1989.

4. Current status of GCP inspection;Kodama,2002

5. Current status of GCP inspection and the inspection of first notice of clinical trials;Onishi;Iyakuhin Kenkyu,2003

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1. A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan;Contemporary Clinical Trials Communications;2019-09

2. Surveillance of protocol deviations in Japanese oncology registration trials: a single institute experience;Investigational New Drugs;2017-02-01

3. An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital;BMC Medical Research Methodology;2013-10-25

4. An international regulatory clinical trial comparative;International Journal of Pharmaceutical and Healthcare Marketing;2013-06-21

5. Compliance with Good Clinical Practice in oncology registration trials in Japan;Annals of Oncology;2011-06

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