Discussion on Partial Validation in Small Molecule Regulated Bioanalysis: Change in Analytical Instruments-Reference-Cited by-同舟云学术

Discussion on Partial Validation in Small Molecule Regulated Bioanalysis: Change in Analytical Instruments

Published:2015 Issue:11 Volume:135 Page:1317-1324
ISSN:0031-6903
Container-title:YAKUGAKU ZASSHI
language:en
Short-container-title:YAKUGAKU ZASSHI

Author:

Nakai Keiko¹,Kamimori Hiroshi²,Nagao Akemi³,Nakayama Akira⁴

Affiliation:

1. Bioanalysis Department, Advanced Technology Center, LSI Medience Corporation

2. Applied Chemistry & Analysis, Research Laboratory for Development, Shionogi & Co., Ltd.

3. Drug Metabolism & Pharmacokinetics Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc.

4. Research Institute, Ajinomoto Pharmaceuticals Co., Ltd.

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology

Link

https://www.jstage.jst.go.jp/article/yakushi/135/11/135_15-00084/_pdf

Reference16 articles.

1. 1) Shah V. P., Midha K. K., Dighe S. V., Pharm. Res., 9, 588-592 (1992).

2. 2) U.S. Food and Drug Administration. “Guidance for Industry: Bioanalytical Method Validation.”: 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf〉, cited 5 September, 2014.

3. 3) European Medicines Agency. “Guideline on Bioanalytical Method Validation.”: 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf〉, cited 5 September, 2014.

4. 4) Ministry of Health, Labour and Welfare. “Guideline on Bioanalytical Method Validation in Pharmaceutical Development.”: 〈http://www.nihs.go.jp/drug/BMV/250711_BMV-GL.pdf〉, National Institute of Health Sciences Web, cited 5 September, 2014.

5. 5) Briggs R. J., Nicholson R., Vazvaei F., Busch J., Mabuchi M., Mahesh K. S., Brudny-Kloeppel M., Weng N., Galvinas P. A. R., Duchene P., Hu P., Abbott R. W., AAPS J., 16, 1143-1148 (2014).