Bioanalytical Method Validation

Jürgen Burhenne^*

Head of the Analytical Chemistry Lab, Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Germany

*Corresponding Author:

Jürgen Burhenne, Ph.D.
Head of the Analytical Chemistry Lab
Department of Clinical Pharmacology and Pharmacoepidemiology
University of Heidelberg
Im Neuenheimer Feld 410
69120 Heidelberg, Germany
Tel: +49 6221 56 36395
Fax: +49 6221 56 5832
E-mail: juergen.burhenne@med.uni-heidelberg.de

Received date: October 27, 2012; Accepted date: October 27, 2012; Published date: November 03, 2012

Citation: Burhenne J (2012) Bioanalytical Method Validation. J Anal Bioanal Tech 3:e111. doi: 10.4172/2155-9872.1000e111

Copyright: © 2012 Burhenne J. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Quantitative bioanalytics in the 1970s and 1980s was often accompanied by peak height determination by ruler, integration with paper and scissors, packed GC columns, and less resolving LC columns. Science and research was based on quantitative data, which was widely accepted as correct, although quality control testing was not generally implemented in university, clinical, or industry laboratories. During those years, doubts arose in particular regarding the correctness of ecological data of plant protection agents, insecticides, and highly chlorinated hydrocarbons, which led to the development of the stringent rules of Good Laboratory Practice (GLP). These rules were incorporated into federal law in many countries and still represent one main cornerstone in supervision for the registration of new chemical entities and in the pre-clinical stage of pharmaceutical drug development.

Aside from these developments, first discussions on how to prove analytical correctness within bioanalytical quantification resulted in famous conference reports [1,2]. During the 1990s, striking analytical developments in chromatography (e.g. 3 μm size particles, varying chemistry in stationary phases) and mass spectrometry (e.g. electrospray ionization, ion trap and tandem mass spectrometry) were achieved, and LC/MS/MS techniques began to enter university and clinical laboratories. The quantification of drugs and metabolites in all kinds of biological matrices gained more and more scientific value, driven by the possibility to answer further pharmacological questions using new LC/MS/MS techniques. To follow the progress in bioanalytical methodologies, an update of the validation procedures was necessary, resulting in another conference report [3] in 2000 and in the FDA Guidance for Industry: Bioanalytical Method Validation [4] in 2001. In recent years, further advances in analytical techniques (e.g. sub 2 μm particles (UHPLC), high-resolution tandem mass spectrometry (QTOF)) have been made, selectivity and sensitivity were significantly improved, and the FDA Guidance became established in the worldwide bioanalytical community. This year, the European Medicines Agency (EMA) put its own guideline on bioanalytical method validation [5] into force, which implemented some new aspects, but remained largely based on the established fundamentals of the FDA Guidance.

The development of bioanalytical method validation principles over the last two decades is an example of a well-accepted regulation within an area of science and scientific research. These validation procedures, defined as guidance, are not written into general law, but nevertheless describe the view of the registration authorities. Therefore, scientific journals publishing new bioanalytical methods should also put a main focus on the quality of applied method validation, and the reviewers should check manuscripts particularly for sufficient and appropriate validation procedures.

References

1. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, et al. (1991) Analytical methods validation: Bioavailability, Bioequivalence and pharmacokinetic studies. J Pharm Sci 81: 309-312.
2. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, et al. (1992) Analytical methods validation: Bioavailability, Bioequivalence and pharmacokinetic studies. Pharm Res 9: 588-592.
3. Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, et al. (2000) Bioanalytical Method Validation – A revisit with a decade of progress. Pharm Res 17: 1551-1557.
4. Food and drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research.
5. European Medicines Agency (2011) Guideline on Bioanalytical Method Validation. Committee for Medicinal Products for Human Use.