Exploratory Analysis of Associations Between Postmarketing Safety Events and Approved Doses of New Drugs in Japan-Reference-Cited by-同舟云学术

Exploratory Analysis of Associations Between Postmarketing Safety Events and Approved Doses of New Drugs in Japan

Published:2017-03-31 Issue:4 Volume:10 Page:280-286
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Okubo TK¹,Ono S¹

Affiliation:

1. Laboratory of Pharmaceutical Regulatory Science; Graduate School of Pharmaceutical Sciences; University of Tokyo; Tokyo Japan

Funder

Ministry of Education, Culture, Sports, Science and Technology

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/cts.12462/fullpdf

Reference20 articles.

1. Industry perspectives on ICH guidelines;Rockhold;Stat. Med,2002

2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonized Tripartite Guideline: Ethnic factors in the acceptability of foreign clinical data 1998

3. Clinical data package of Japanese NDA (in Japanese);Yasuda;OPIR Research Paper Series 2008,2008

4. Ministry of Health, Labor and Welfare, Japan Basic Principles On Global Clinical Trials 2007

5. Clinical development and review time of Japanese NDA (in Japanese);Kagayama;OPIR Research Paper Series 2015,2015

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