Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays-Reference-Cited by-同舟云学术

Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays

Published:2015-05 Issue:9 Volume:7 Page:1151-1156
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Imazato-Hirano Mami¹,Taniguchi Yoshitaka²,Kakehi Masaaki³,Kuze Yoji³,Nakamura Takahiro⁴,Minamide Yoshiyuki⁵,Miya Kazuhiro⁶,Hosogi Jun⁷,Katashima Masataka⁸⁹,Maekawa Kotaro⁹¹⁰,Okuda Haruhiro¹¹,Niimi Shingo¹¹,Kawasaki Nana¹¹,Ishii-Watabe Akiko¹¹,Katori Noriko¹¹

Affiliation:

1. Novartis Pharma, Toranomon Hills Mori Tower, 23–1, Toranomon 1-chome, Minato-ku, Tokyo 105–6333, Japan

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

3. Takeda Pharmaceutical, 26–21, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251–8555, Japan

4. Shin Nippon Biomedical Laboratories, 2438 Miyanoura, Kagoshima 891–1394, Japan

5. Shimadzu Techno-Research, 1, Nishinokyo-Shimoaicho, Nakagyo-ku, Kyoto 604–8436, Japan

6. Chugai Pharmaceutical, 200 Kajiwara, Kamakura, Kanagawa 247–8530, Japan

7. Kyowa Hakko Kirin, 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411–8731, Japan

8. Astellas Pharma, 2–5–1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103–8411, Japan

9. Japan Pharmaceutical Manufacturers Association (JPMA), Drug Evaluation Committee, Torii Nihonbashi Building, 3–4–1 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103–0023, Japan

10. Hisamitsu Pharmaceutical, 2–4–1, Marunouchi, Chiyoda-ku, Tokyo 100–6330, Japan

11. National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, 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.15.43

Reference19 articles.

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

2. Japanese Ministry of Internal Affairs and Communications. Answers to public opinions about “The Draft Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development” (in Japanese only). http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495130226&Mode=2.

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