Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09-Reference-Cited by-同舟云学术

Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09

Published:2016-01 Issue:2 Volume:8 Page:93-98
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Niwa Makoto¹,Koseki Nozomu²,Hashimoto Yoshitaka³,Mayumi Tsuyoshi⁴,Nishimura Naohiro⁵,Satsukawa Masahiro⁶,Uchimura Takahide⁷,Yasuda Yutaka⁸,Yokoi Hiroyuki⁹

Affiliation:

1. Pharmacokinetics Team, Pharmaceutical Research Laboratories, Nippon Kayaku Co., Ltd. 3-31-12 Shimo, Kita-ku, Tokyo 115–8588, Japan

2. Kyorin Pharmaceutical Co., Ltd., 1848 Nogi, Nogi-machi, Shimotsuga-gun, Tochigi 329-0114, Japan

3. Ono Pharmaceutical Co., Ltd. 17-2 Wadai, Tsukuba-shi, Ibaraki 300-4247, Japan

4. Mitsubishi Tanabe Pharma Corporation 3-2-10, Dosho-machi, Chuo-ku, Osaka 541-8505, Japan

5. Sumika Chemical Analysis Service, Ltd., 1-135, Kasugade-Naka 3-chome, Konohana-ku, Osaka554-0022, Japan

6. Kaken Pharmaceutical Co., Ltd. 301 Gensuke, Fujieda-shi, Shizuoka 426-8646, Japan

7. Chugai Research Institute for Medical Science, Inc. 200 Kajiwara, Kamakura, Kanagawa 247-8530, Japan

8. Toray Research Center, Inc. 6-10-1 Tebiro, Kamakura, Kanagawa 248-0036, Japan

9. Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima 771-0192, Japan

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.15.236

Reference15 articles.

1. Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum

2. Ministry of Health, Labour and Welfare. Guideline on bioanalytical method validation in pharmaceutical development. (PFSB/ELD Notification No. 0711-1) (2013).www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf.

3. Tiered approach into practice: scientific validation for chromatography-based assays in early development – a recommendation from the European Bioanalysis Forum

4. Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Giving consideration to scientific validation in Japanese drug application by Japan Bioanalysis Forum discussion group;Bioanalysis;2017-07