Development of a Practical HPLC Method for In-hospital Quantitation of Various Medicinal Drugs at Blood Levels

Author:

MORIKAWA Go1,SORIMACHI Miho2,TAMURA Kazuki2,MORIIWA Yukiko2,SHOJI Atsushi2,OKAZAWA Katsuko1,YANAGIDA Akio2

Affiliation:

1. Department of Pharmacy, Hokushin General Hospital

2. Department of Biomedical Analysis, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences

Publisher

Japan Society for Analytical Chemistry

Subject

Analytical Chemistry

Reference4 articles.

1. 1) B. H. Dvorchik, E. S. Vessell : Clin. Chem., 22, 868 (1976).

2. 6) FDA, CDER and CMV (in U.S.A) : Bioanalytical method validation : Guidance for industry, 24 May 2018, <https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf>.

3. 7) European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) : Guideline on bioanalytical method validation, 21 July 2011, <https://www.ema.europa.eu/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf>.

4. 11) G. Maine, P. Taylor, G. Veen, P. Wallemacq : Clin. Chem., 58, 821 (2012).

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