International harmonization of bioanalytical guidance
2010; Future Science Ltd; Volume: 2; Issue: 4 Linguagem: Inglês
10.4155/bio.10.39
ISSN1757-6199
AutoresSurendra K. Bansal, Mark E. Arnold, Fabio Garofolo,
Tópico(s)Metabolomics and Mass Spectrometry Studies
ResumoBioanalysisVol. 2, No. 4 EditorialFree AccessInternational harmonization of bioanalytical guidanceSurendra K Bansal, Mark Arnold & Fabio GarofoloSurendra K Bansal† Author for correspondenceHoffmann-La Roche Inc., Nutley, NJ, USA. , Mark ArnoldBristol-Myers Squibb Company, Princeton, NJ, USA. & Fabio GarofoloAlgorithme Pharma Inc., Laval, QC, Canada. Published Online:13 Apr 2010https://doi.org/10.4155/bio.10.39AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Science and regulations both have their place and importance in bioanalysis. We may not know the exact timing of their origin, but bioanalysts know that they have co-existed for many years, and that both have progressed with controlled but constant transformation. One has influenced the other but, by and large, science and regulations have had their individual developmental pathways.When we talk of scientific development, bioanalysis has seen some excellent progress in multiple areas, for example speed, specificity, sensitivity, sample size and data volume. As both our technologies and knowledge of the implications of endogenous sample matrices have improved, we can now develop highly sensitive and specific bioanalytical methods for analysis of drugs and metabolites in complex matrices in a matter of days using LC–MS/MS, whereas it used to take months to develop even a method with several orders of magnitude lower sensitivity. LC–MS/MS has revolutionized the bioanalytical field, just as the internet has revolutionized the information field. We can no longer imagine getting information without internet searches. Similarly, we cannot imagine developing bioanalytical methods of adequate sensitivity and specificity using LC–UV. Equally impactful has been the explosive growth in immunoassay technology for biologic therapeutics with its improvements in sample volume requirements, specificity, multiplexing capabilities and speed. Automation, speed of analysis, data capture and archive have all but replaced the classical approaches of bioanalysis.Parallel to this dramatic scientific progress in the bioanalytical field, rules and regulations have also been revised or new ones have been introduced. However, the regulatory rules and guidance revision/additions have taken their own course. In the old days, we had regulations, but no specific guidance on how to perform the bioanalytical work. The regulations required that bioanalytical methods should be demonstrated to be accurate and of sufficient sensitivity to measure drugs and metabolites with appropriate precision. It was left to the scientist to develop and present sufficient scientific evidence that the bioanalytical work followed and conformed to the regulations. Then came the first joint conference/workshop of scientists and regulators in 1990, popularly known as the 'Crystal City Bioanalytical Conference.' The workshop had global participation and developed essential parameters for bioanalytical methods validation. The workshop recommendations were documented in a scientific White Paper [1].The first Crystal City White Paper provided detailed procedures and requirements on how to validate and use the bioanalytical methods to measure drug and metabolite concentrations in biological matrices. The requirements, procedures and interpretations were equally acceptable to both the practitioners and regulators of bioanalysis. The paper rapidly grew in popularity around the world, as it provided a harmonized framework for bioanalytical processes to meet the expectations of regulatory review and inspections. It minimized individual interpretations or long explanations on how a scientist would quantitatively determine parameters of an assay to measure its sensitivity, accuracy and precision. Scientists loved it because it established a clear set of expectations and they did not have to individually devise and develop ways to fulfill the regulatory requirements for bioanalysis. A decade later there was another 'Crystal City Bioanalytical Conference/Workshop' and the US FDA issued regulatory guidance on bioanalysis [2]. It was issued as guidance, and not as new regulation (law). Not following the guidance is considered acceptable, as long as you justify the alternative approach. Questions lingered with bioanalysts on how to make sure that the alternative approach(es) would be considered equivalent to providing the essential parameters to prove the accuracy, precision and sensitivity of the assay. Therefore, bioanalysts started to follow the guidance and subsequent White Papers to the tee.Bioanalytical science for both large and small molecules continued progression at an unprecedented rate. Further conferences and workshops with regulators' participation were held around the world, and the FDA guidance was supplemented by additional White Papers. In this rapidly developing era of bioanalysis, it is no longer sufficient to perform the work according to the FDA guidance; one must also conform to the new requirements provided in White Papers. Recently, the European Medicines Agency (EMA) issued a draft guideline [3] on the validation of bioanalytical methods. This draft guideline is very similar to the FDA Guidance and Crystal City conference reports, and keeps the legacy of bioanalytical practice that has been in use for the last two decades. However, it does contain a few differences. The FDA is also revising its 2001 guidance [2]. It is very reassuring to see that the regulatory agencies are providing guidance that is changing with the continuous evolution of bioanalytical science. It is in the best interests of everyone to adopt simple guidance whose interpretations would be equally acceptable to both the practitioners and regulators of bioanalysis.In this global economy, many pharmaceutical companies and contract research organizations generate bioanalytical data that are submitted to regulatory agencies around the world. Studies are conducted globally with the samples analyzed in one country and the results submitted to regulatory agencies in other countries. Multiple guidance and regulations create additional burden to performing quality science in a global work place and create potential conflicts with each other in substance and/or interpretation. It would be of great benefit to the industry and regulatory agencies if bioanalytical guidelines were harmonized among major regulatory agencies such as the EMA, FDA, Japanese MHLW, Canadian HC-TPD, Brazilian ANVISA and Australian TGA. Does a system exist for creating a joint regulatory guidance that could be accepted globally? We are not aware of any such system or document of agreement that would be universally acceptable to the regulatory agencies around the world. So what is the solution? One solution could be going back to the 1990s, when there were regulations for performing bioanalytical work but the scientific guidance was provided through White Papers accepted by both bioanalysts and regulatory agencies. As the scientific development continues at a rapid pace, this hybrid process of the 1990s may provide a solution where good science and compliance would co-exist and thrive to provide necessary regulatory data to drive new medicines to patients globally. As was neccessary in the past, this system would require a commitment from regulatory agencies and practitioners of bioanalysis to join forces in extended global bioanalytical workshops. Already, the major conferences have global participation. All we need is an increased participation of representatives from more regulatory agencies. Such a 'World Congress of Bioanalysis' equivalent to an extended 'Crystal City Bioanalytical Conference/Workshop' could tie up the loose ends of bioanalytical differences by providing consensus reports acceptable to both the practitioners and regulators of bioanalysis.Additionally, or alternatively, if OECD guidelines or consensus documents could be accepted by worldwide regulatory agencies, the bioanalytical guidance created under the auspices of the OECD with active participation/comments from the global bioanalytical community, would achieve the desired global harmonization. Keeping pace with high-quality science, harmonized scientific guidance would be the key to providing uniform procedures meeting global regulatory expectations. To the extent that such a document would foster improved scientific quality and compliance, the results would benefit both the regulatory agencies and the pharmaceutical industry. Ultimately, the patients using pharmaceutical products would be the winners through the consistent generation of high-quality data and faster and more consistent review practices.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.Bibliography1 Shah VP, Midha KK, Dighe S et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Phar. Res.9(4),588–592 (1992).Crossref, Google Scholar2 US FDA. Guidance for industry: bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (2001).Google Scholar3 European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on Validation of Bioanalytical Methods (Draft), EMA/CHMP/EWP/192217/2009.Google ScholarFiguresReferencesRelatedDetailsCited BySimultaneous Determination of Four Tanshinones by UPLC-TQ/MS and Their Pharmacokinetic Application after Administration of Single Ethanol Extract of Danshen Combined with Water Extract in Normal and Adenine-Induced Chronic Renal Failure Rats28 November 2016 | Molecules, Vol. 21, No. 12Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team2 October 2014 | The AAPS Journal, Vol. 16, No. 6Bioanalytical method validation and bioanalysis in regulated settingsInternational Regulations and Quality Standards of Bioanalysis30 August 2013Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy30 August 2013What are the challenges of stability investigations and sample stabilization in regulated bioanalysis?Katja Heinig, Elke Zwanziger & 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13 April 2010 Published in print April 2010 Information© Future Science LtdFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download
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