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

Author:

Katori Noriko1

Affiliation:

1. Project Team for Pharmacogenetics, National Institute of Health Sciences,1-18-1 Kamiyoga, 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

Reference17 articles.

1. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

2. Conference Report: International harmonization of bioanalysis regulation: discussion in Global Bioanalysis Consortium harmonization teams

3. Ministry of Health, Labor and Welfare.Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies. PAB/ELD Notification No. 443, 2 July 1996, MHLW, Japan.

4. Ministry of Health, Labor and Welfare.Note on Clinical Pharmacokinetic Studies of Pharmaceuticals. PFSB/ELD Notification No. 796 1 June 2001, MHLW, Japan.

5. Ministry of Health, Labor and Welfare.Guideline on Nonclinical Pharmacokinetics. PNSB/ELD Notification No. 496. 26 June 1998, MHLW, Japan.

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