Medical Writing Non-Clinical Health Writing Writing bioanalytical reports

Volume 23, Issue 3 - Non-Clinical Health Writing

Writing bioanalytical reports

Abstract

Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article covers essential aspects of reporting bioanalytical results, including the key parameters of bioanalysis, regulatory requirements, and the content and structure of bioanalytical reports. It will also be of interest to medical writers who deal with bioequivalence and other pharmacokinetic trials.

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References

  1. Verhaeghe T, Barton HH, Hara H, Hucker R, Kelley M, Picard F, et al. Recommendations from the Global Bioanalysis Consortium Team A8: documentation. AAPS J 2014;16(2):240–5.
  2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation. May 2001.
  3. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009). July 2011.
  4. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Workshop/conference report – quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J 2007;9(1):E30–42.
  5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation. Draft guidance. September 2013.
  6. European Medicines Agency, Committee for Human Medicinal Products. Questions & answers: positions on specific questions addressed to the pharmacokinetics working party (EMA/618604/2008 Rev. 9). May 2014.
  7. Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J 2007;9(1):E43–7.
  8. van Amsterdam P, Companjen A, Brudny-Kloeppel M, Golob M, Luedtke S, Timmerman P. The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on bioanalytical method validation. Bioanalysis 2013;5(6):645–59.
  9. Brazilian Health Surveillance Agency. Guide for validation of analytical and bioanalytical methods. RE n. 899. May 2003.
  10. Fast DM, Kelley M, Viswanathan CT, O'Shaughnessy J, King SP, Chaudhary A, et al. Workshop report and follow-up – AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples – implications of Crystal City recommendations. AAPS J 2009;11(2):238–41.
  11. European Bioanalysis Forum. Publications: regulatory documents [accessed 2014 May 07]. Available from: http://www.europeanbioanalysisforum.eu/publications_regulatory.php
  12. Global Bioanalysis Consortium. Bibliography: regulatory [accessed 2014 May 07]. Available from: http://www.globalbioanalysisconsortium.org/Regulatory
  13. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations. Revision 1. March 2003.
  14. European Medicines Agency, Committee for Human Medicinal Products. Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr**). January 2010.
  15. European Medicines Agency, Committee for Human Medicinal Products. Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (CHMP/EWP/89249/2004). January 2007.
  16. Jones AB. Bioanalytical quality assurance: concepts and concerns. Qual Assur J 2006;10:101–6.
  17. European Medicines Agency, GCP Inspectors Working Group. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010). February 2012.
  18. Huntsinger DW. OECD and USA GLP applications. Ann Ist Super Sanita 2008;44(4):403–6.
  19. European Medicines Agency. Overview of comments received on draft guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1 (EMA/CHMP/EWP/26817/2010). January 2010.
  20. European Medicines Agency, GCP Inspectors Working Group. Annex VII to procedure for conducting GCP inspections requested by the EMEA: bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (EMEA/INS/GCP/97987/2008). May 2008.
  21. World Health Organization. Good clinical laboratory practice. March 2009.
  22. Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. PLoS Med 2009;6(5):e1000067.
  23. European Medicines Agency, Committee for Human Medicinal Products. Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): presentation of biopharmaceutical and bioanalytical data in Module 2.7.1 (EMA/CHMP/600958/2010/Corr). November 2011.
  24. European Commission, Enterprise and Industry Directorate-General. Questions and answers concerning the implementation of Directives 2004/9/EC and 2004/10/EC on good laboratory practice (GLP). April 2013.
  25. Health Canada. Draft comprehensive summary – bioequivalence (CS-BE). May 2004.

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