Tiered approach to metabolite quantification: regional practices reviewed by Japan Bioanalysis Forum discussion group-Reference-Cited by-同舟云学术

Tiered approach to metabolite quantification: regional practices reviewed by Japan Bioanalysis Forum discussion group

Published:2015-05 Issue:8 Volume:7 Page:935-938
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Niwa Makoto¹,Uchimura Takahide²,Koseki Nozomu³,Satsukawa Masahiro⁴,Hashimoto Yoshitaka⁵,Mayumi Tsuyoshi⁶,Yasuda Yutaka⁷,Yokoi Hiroyuki⁸

Affiliation:

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

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

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

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

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

6. Mitsubishi Tanabe Pharma Corporation, 2–6–18 Kitahama, Chuo-ku, Osaka 541–8505 Japan

7. Toray Research Center, Inc., 6–10–1 Tebiro, Kamakura, Kanagawa 248–0036 Japan

8. 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.15.34

Reference14 articles.

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

2. Guideline on Bioanalytical Method Validation in Pharmaceutical Development. Notification No. 0711–1 issued by Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Government of Japan (2013). www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf.

3. Tiered Approaches to Chromatographic Bioanalytical Method Performance Evaluation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

4. Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation

5. 5th JBF Symposium: 'Bridging for a Global Harmonization'

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