The Pathology Community's Interpretation of Settiagounder’s Proposals on GLP Process as Applied to Pathology Peer Review

Authors

  • Bindu Bennet Janssen Rsearch and Development

DOI:

https://doi.org/10.21423/JRS-V06N01PV

Keywords:

athology, peer review, GLP, toxicologic pathology, nonclinical toxicology, safety asessment

Abstract

https://doi.org/10.21423/jrs-v06n01pv (DOI assigned 1/24/2019)

References

Crissman, J. W., Goodman, D. G., Hildebrandt, P. K., Maronpot, R. R., Prater, D. A., Riley, J. H., Seaman, W. J., and Thake, D. C. (2004). Best practices guideline: Toxicologic histopathology. Toxicol Pathol 32, 126–31.

Fikes, J. D., Patrick, D. J., Francke, S., Frazier, K. S., Reindel, J. F., Romeike, A., Spaet, R. H., Tomlinson, L., and Schafer, K. A. (2015). Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology. Toxicol Pathol, 43, 907-914.

Mann, P. C., and Hardisty, J. F. (2013). Peer review and pathology working groups. In Handbook of Toxicologic Pathology (W. M. Haschek, C. G. Rousseaux, M. A. Wallig, B. Bolon, R. Ochoa, and B. W. Mahler, eds.), 3rd ed., pp. 551–64. Elsevier, New York.

Morton, D., Sellers, R., Barale-Thomas, E., Bolon, B., George, C., Hardisty, J., Irizarry, A., McKay, J. S., Odin, M., and Teranishi, M. (2010). Recommendations for pathology peer review. Toxicol Pathol 38, 1118–27.

Organisation for Economic Co-operation and Development. (2014) OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 16. Advisory Document of the Working Group on Good Laboratory Practice, Guidance on the GLP Requirements for Peer Review of Histopathology, ENV/JM/MONO (2014)30, 1-11. Retrieved from http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2014)30&doclanguage=en

Organisation for Economic Co-operation and Development Good Laboratory Practice: Frequently asked questions (FAQ), posted 27 March, 2017. Retrieved from http://www.oecd.org/chemicalsafety/testing/glp-frequently-asked-questions.htm

Settiagounder, N. Histopathology Evaluation and Peer Review for Nonclinical Studies: Raw Data Compliance to GLP Quality Systems. Journal of Regulatory Science 5(2) (2017a) 45–55

Settiagounder, N: Histopathology Peer Review for Nonclinical Studies – GLP Processes and Conditions. Journal of Regulatory Science 5(2) (2017b) 56–66

U.S. Food and Drug Administration. (1987). Good Laboratory Practice Regulations; Final Rule, Federal Register 52, 33768–82. Retrieved from https://www.fda.gov/ICECI/Inspections/NonclinicalLaboratoriesInspectedunderGoodLaboratoryPractices/ucm072706.htm

U.S. Food and Drug Administration. (2016). Good Laboratory Practice for Nonclinical Laboratory Studies; Proposed Rule, 21 CFR § 16 & 58. Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2016-08- 24/pdf/2016-19875.pdf

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Published

2018-03-30

Issue

Vol 6, No 1 (2018)

Section

Letter to the Editor

License

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