5.    バイオアナリシス：Bioanalysis (under construction)

5-0. 定義　Difinition:

Bioanalysis is one of the sub categories of Chemistry that helps in measuring Xenobiotics (unnatural concentration or location of drugs, Metabolites and biological molecules) in biological system. By Journal of Bioanalysis & Biomedicine

This difinition is also cited in Wikipedia with same modifications: Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems.. This article in Wiki is a good starting point to learn on Bioanalysis.

5-1. Guidelines on Bioanalysis Method Validation

Japan:

- 「医薬品開発における生体試料中薬物濃度分析法のバリデーションに関するガイドライン」について, 及びQ&A [薬食審査発0711第1号, Jul.11, 2013]:
　　Guideline on Bioanalytical Method Validation in Pharmaceutical Development (LC, small molecule) and Q&A;

- 「医薬品開発における生体試料中薬物濃度分析法（リガンド結合法）のバリデーションに関するガイドライン」について[薬食審査発0401第1号, Apr.1, 2014]
　　Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development: (English translation was issued on May 30, 2014)

USA:

- Bioanalytical Method Validation (PDF - 63KB) [Final Guidance 05/01/01]

- Bioanalytical Method Validation [Revised Final] (PDF - 526KB)[Draft Guidance　09/12/13]

EU:

- Guideline on Validation of Bioanalytical Methods (EMA draft 2009)

AAPS-FDA Workshop White Paper in 2007 : Workshop/Conference Report ? Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

5-2. Guidelines for Bioanalytical Labs.

Japan:

- 検体測定室に関するガイドラインに係る疑義解釈集（Q＆A）, Jun, 2014]:

- 検体測定室に関するガイドラインについて[医政発0409第４号, Apr.9, 2014]
　

5-3. Links

-   Japan Bioanalysis Forum: バイオアナリシスフォーラム

-     Bioanalysis.　January 2014, Vol. 6, No. 1, Pages 13-19 , DOI 10.4155/bio.13.298　(doi:10.4155/bio.13.298)  [Commentary] New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR. Dieter Zimmer:　

5-4. Educational materials

-  Mass Spectrometry and Biotechnology Resource Created and Edited by Andrew Guzzetta: Site with very links for mass spectrometry including tutorials, freeware

- MIT OPEN COURSEWARE : Chemistry : Multiple chemistry instrumentation courses

- The Virtual Mass Spectrometry Laboratory: Virtual mass spectrometry laboratory with tutorial and excellent case study examples. In-depth course materials for chemistry

(Homeへ戻る）

(The latest modification on Jul. 7, 2016.)