Bioanalysis Zone

CRO commentary on the importance of harmonization and the impact of the ICH M10

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Key words: bioanalysis, CRO, GCC, global, guidance, harmonization, ICH M10, validation

Global harmonization of best practices in bioanalysis has been a goal within the bioanalytical industry for quite a number of years, dating back as far as the first so-called ‘Crystal City’ meeting in 1990. That meeting, sponsored by the American Association of Pharmaceutical Scientists along with the US FDA, started the development of the initiative to introduce consistent guidelines across the regulated bioanalytical industry. These efforts ultimately lead to a White Paper summarizing the conference outcome and subsequent release of the 2001 FDA guidance document [1,2], which significantly harmonized bioanalytical validations industry wide. Subsequent guidance documents [3–9] have been generated and added to or clarified validation requirements, but also introduced minor but notable differences in study conduct. The release of the first draft global regulatory Guideline on Bioanalytical Method Validation from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in February of 2019 [10] will be able to further harmonize bioanalytical validations and sample analysis studies, and provide for a more consistent understanding of global regulatory expectations. The release of this draft guidance and ultimately its finalization will have tremendous positive implications across the regulated bioanalysis segment of the pharmaceutical industry. There are many stakeholders including Pharmaceutical Developers, Regulators and the Contract Research Organizations (CROs). Each has a unique perspective on their drivers for a globally harmonized, properly written and well understood global guideline.

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Several members of the GCC who led the ICH M10 discussion teams were happy to provide personal thoughts and commentary on the ICH M10 and participated in a featured series of interviews.

Click here to read the full series of expert interviews!

  1. Shah VP, Midha KK, Dighe S et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies: sponsored by the American Association of Pharmaceutical Chemists, U.S. Food and Drug Administration, Fédération Internationale Pharmaceutique, Health Protection Branch (Canada) and Association of Official Analytical Chemists. Int. J. Pharm. 82(1–2), 1–7 (1992).
  2. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry, bioanalytical method validation (2001). www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf
  3. EMA. Committee for medicinal products for human use (CHMP). Guideline on bioanalytical method validation (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
  4. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry, bioanalytical method validation (2018). www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry
  5. ANVISA. Resolution RDC 27 minimum requirements for bioanalytical method validation used in studies with the purpose of registration and post-registration of medicines. Agencia National de Vigilancia Sanitaria, Brazil (2012). http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jo rnal=1&pagina=93&data=22/05/2012
  6. Japanese Ministry of Helath, Labour & Welfare. Guideline on bioanalytical method validation in pharmaceutical development (2013). www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdf
  7. Japanese Ministry of Helath, Labour & Welfare. Guideline on bioanalytical method (ligand binding assay) validation in pharmaceutical development (2014). www.nihs.go.jp/drug/BMV/260530_LBA-GL_E.pdf
  8. Health Canada, Bureau of Pharmaceutical Sciences Therapeutic Products Directorate. Notice: clarification of bioanalytical method validation procedures (2015). www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-clarification-bioanalytical-method-validation-procedures.html
  9. Health Canada, Bureau of Pharmaceutical Sciences Therapeutic Products Directorate. Addendum to notice: clarification of bioanalytical method validation procedures (2016). www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-clarification-bioanalytical-method-validation-procedures.html#a1
  10. International Council for harmonisation of technical requirements for pharmaceuticals for human use. ICH harmonised guideline. Bioanalytical method validation M10 (2019). www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M10/M10EWG_Step2_DraftGuideline_2019_0226.pdf
  11. Premkumar N, Lowes S, Jersey J et al. Formation of a global contract research organization council for bioanalysis. Bioanalysis 2(11), 1797–1800 (2010).
  12. Lowes S, Jersey J, Shoup R et al. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. Bioanalysis 3(12), 1323–1332 (2011).
  13. Breda N, Garofolo F, Cruz Caturla M et al. The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis 3(24), 2721–2727 (2011).
  14. Boterman M, Doig M, Breda M et al. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis 4(6), 651–660 (2012).
  15. Lowes S, Jersey J, Shoup R et al. Conference report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and carryover. Bioanalysis 4(7), 763–768 (2012).
  16. Sangster T, Maltas J, Struwe P et al. Recommendations on ISR in multi-analyte assays, Qa/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC). Bioanalysis 4(14), 1723–1730 (2012).
  17. Lowes S, Boterman M, Doig M et al. GCC recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs. Bioanalysis 4(17), 2117–2126 (2012).
  18. Nicholson R, Lowes S, Caturla MC et al. Sixth GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis 4(19), 2335–2342 (2012).
  19. Hougton R, Gouty D, Allinson J et al. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis 4(20), 2439–2446 (2012).
  20. Lowes S, LeLacheur R, Shoup R et al. Recommendations on incurred sample stability (ISS) by GCC. Bioanalysis 6(18), 2385–2390 (2014).
  21. Rocci M, Lowes S, Shoup R et al. 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. Bioanalysis 6(20), 2713–2720 (2014).
  22. Bower J, Fast D, Garofolo F et al. Eighth GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation. Bioanalysis 6(22), 2957–2963 (2014).
  23. Hayes R, LeLacheur R, Dumont I et al. Ninth GCC Closed Forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks. Bioanalysis 8(6), 487–495 (2016).
  24. Cape S, Islam R, Nehls C et al. The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud. Bioanalysis 9(7), 505–516 (2017).
  25. Islam R, Briscoe C, Bower J et al. Eleventh GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation. Bioanalysis 10(7), 433–444 (2018).
  26. Islam R, Kar S, Ritzén H et al. Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis. Bioanalysis 11(7), 645–653 (2019).
  27. Nehls C, Buonarati M, Cape S et al. GCC consolidated feedback to ICH on the 2019 ICH M10 Bioanalytical method validation draft guideline. Bioanalysis 11(18), (2019).

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