Giving consideration to scientific validation in Japanese drug application by Japan Bioanalysis Forum discussion group-Reference-Cited by-同舟云学术

Giving consideration to scientific validation in Japanese drug application by Japan Bioanalysis Forum discussion group

Published:2017-07 Issue:13 Volume:9 Page:963-968
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Koseki Nozomu¹,Ashizawa Hiroko²,Ishii Takuho³,Uchimura Takahide⁴,Ono Keita⁵,Kuriyama Saori⁶,Toda Akiko⁷,Soejima Kuretake⁸,Nakai Naoko⁹,Nishimura Naohiro¹⁰,Mayumi Tsuyoshi¹¹,Yasuda Yutaka¹²,Yamakawa Tatsuya¹³,Niwa Makoto¹⁴

Affiliation:

1. Kyorin Pharmaceutical Co., Ltd., DMPK Research Laboratory, Watarase Research Center, 1848, Nogi, Nogi-machi, Shimotsuga-gun, Tochigi, 329–0114, Japan

2. Kaken Pharmaceutical Co., Ltd., Pharmacokinetics and Safety Department, Drug Research Center, 301 Gensuke, Fujieda-shi, Shizuoka, 426-8646, Japan

3. Sunplanet Co., Ltd., DMPK&Bioanalysis Unit, Tsukuba R&D Supporting Division, 5-1-3 Tokodai, Tsukuba-shi, Ibaraki, 300-2635, Japan

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

5. Taiho Phamaceutical Co., Ltd., Bioanalytical Research & Development, Pharmacokinetics research Laboratories, Discovery and Preclinical Research Division, 3 Ohkubo, Tsukuba-shi, Ibaraki, 300-2611, Japan

6. Nippon Shinyaku Co., Ltd., Pharmacokinetics and Safety Assessment Department. Discovery Research Laboratories, 14 Nishinosho-monguchi-cho, Kisshoin, Minami-ku, Kyoto, 601-8550, Japan

7. Shin Nippon Biomedical Laboratories, Ltd., Analysis Research Department, Drug Safety Research Laboratories, 2438 Miyanoura, Kagoshima, 891-1394, Japan

8. Meiji Seika Pharma Co., Ltd., Pharmacokinetics and Analysis Laboratory, Pharmaceutical Research Center, 760 Morooka-cho, Kohoku-ku, Yokohama 222-8567, Japan

9. Daiichi Sankyo Co., Ltd., Clinical Pharmacology Department, R&D Division, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan

10. Sumika Chemical Analysis Service, Ltd., Chemicals Compliance Division,22-5 Hongo 3-chome, Bunkyo-ku, Tokyo, 113-0033, Japan

11. Zensei Pharmaceutical Co., Ltd., Analytical Research & Development Section, 380 Mita-cho, Kishiwada-shi, Osaka, 596-0808, Japan

12. Toray Research Center, Inc., Biomedecal Analysis Labolatories, Research Division, 6-10-1 Tebiro, Kamakura, Kanagawa, 248-0036, Japan

13. Fujifilm Corporation, Pharmaceutical & Healthcare Research Laboratories, Research & Development Management Headquarters, 2-4-1 Shimookui, Toyama, 930-8508, Japan

14. Nippon Kayaku Co., Ltd., Pharmaceutical Research Laboratories, Research & Development Group, 3-31-12 Shimo, Kita-ku, Tokyo,115-8588, 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-2017-0092

Reference10 articles.

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

2. Regulated bioanalysis in Japan: where do we come from and where are we going?

3. 7th Japan Bioanalysis Forum symposium: regulated bioanalysis, to a new stage

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

5. Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis