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Boorman, G., Dixon, D., Elwell, M., Kerlin, R., Morton, D., Peters, T., Regan, K., & Sullivan, J. (2003).
Assessment of Hyperplastic Lesions in Rodent Carcinogenicity Studies. Toxicologic Pathology, 31(6), 709–710. doi:10.1080/01926230390262276 -
Burkhardt, J. E., Pandher, K., Solter, P.F., Troth, S. P., Boyce, R. W., Zabka, T. S., & Ennulat, D. (2011).
Recommendations for the Evaluation of Pathology Data in Nonclinical Safety Biomarker Qualification Studies. Toxicologic Pathology, 39(7), 1129–1137. doi:10.1177/0192623311422082 -
Engelhardt, J. A., Fant, P., Guionaud, S., Henry, S. P., Leach, M. W., Louden, C., Scicchitano, M. S., Weaver, J. L., Zabka, T. S., & Frazier, K. S. (2015).
Scientific and Regulatory Policy Committee Points-to-consider Paper*:Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides. Toxicologic Pathology, 43(7), 935–944. doi:10.1177/0192623315570341 -
Frazier, K. S., Engelhardt, J. A., Fant, P., Guionaud, S., Henry, S. P., Leach, M. W., Louden, C., Scicchitano, M. S., Weaver, J. L., & Zabka, T. S. (2015).
Scientific and Regulatory Policy Committee Points-to-consider Paper*:Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics. Toxicologic Pathology, 43(7), 915–934. doi:10.1177/0192623315570340 -
Irizarry Rovira, A. R., Bennet, B. M., Bolon, B., Braendli-Baiocco, A., Chandra, S., Fleurance, R., Garman, R., Hutto, D., Lane, J., Romeike, A., Sargeant, A., & Zimmerman, B. (2018).
Scientific and Regulatory Policy Committee Points to Consider: Histopathologic Evaluation in Safety Assessment Studies for PEGylated Pharmaceutical Products. Toxicologic Pathology, 46(6), 616–635. doi:10.1177/0192623318791801 -
Keane, K. A., Parker, G. A., Regan, K. S., Picut, C., Dixon, D., Creasy, D., Giri, D., & Hukkanen, R. R. (2015).
Scientific and Regulatory Policy Committee (SRPC) Points to Consider:Histopathology Evaluation of the Pubertal Development and Thyroid Function Assay (OPPTS 890.1450, OPPTS 890.1500) in Rats to Screen for Endocrine Disruptors. Toxicologic Pathology, 43(8), 1047–1063. doi:10.1177/0192623315579943 -
Keenan, C., Elmore, S., Francke-Carroll, S., Kemp, R., Kerlin, R., Peddada, S., Pletcher, J., Rinke, M., Schmidt, S. P., Taylor, I., & Wolf, D. C. (2009).
Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions. Toxicologic Pathology, 37(5), 679–693. doi:10.1177/0192623309336154
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Elmore, S., & Peddada, S., (2009).
Points to Consider on the Statistical Analysis of Rodent Cancer Bioassay Data When Incorporating Historical Control Data. Toxicologic Pathology, 37(5), 672–676. doi:10.1177/0192623309339606
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Elmore, S., & Peddada, S., (2009).
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Keirstead, N. D., Janovitz, E. B., Meehan, J. T., LeRoy, B. E., Megill, J. R., Peterson, R. A., Masson, R. G., & Marxfeld, H. A. (2019).
Scientific and Regulatory Policy Committee Points to Consider*: Review of Scientific and Regulatory Policy Committee Points to Consider: Review of Current Practices for Ultrastructural Pathology Evaluations in Support of Nonclinical Toxicology Studies. Toxicologic Pathology, 47(4), 461–468. doi:10.1177/0192623319835170 -
Kerlin, R., Bolon, B., Burkhardt, J., Francke, S., Greaves, P., Meador, V., & Popp, J. (2016).
Scientific and Regulatory Policy Committee: Recommended (“Best”) Practices for Determining, Communicating, and Using Adverse Effect Data from Nonclinical Studies. Toxicologic Pathology, 44(2), 147–162. doi:10.1177/0192623315623265 -
Michael, B., Yano, B., Sellers, R. S., Perry, R., Morton, D., Roome, N., Johnson, J. K., & Schafer, K. (2007).
Evaluation of Organ Weights for Rodent and Non-Rodent Toxicity Studies: A Review of Regulatory Guidelines and a Survey of Current Practices. Toxicologic Pathology, 35(5), 742–750. doi:10.1177/01926230701595292 -
Morton, D. (2001).
The Society of Toxicologic Pathology's Position on Statistical Methods for Rodent Carcinogenicity Studies. Toxicologic Pathology, 29(6), 670–672. doi:10.1080/019262301753386004 -
PETO Analysis Working Group of STP. (2001).
Draft Recommendations on Classification of Rodent Neoplasms for Peto Analysis. Toxicologic Pathology, 29(2), 265–268. doi:10.1080/019262301317052558 -
Best practice paper from Bone Marrow Working Group of ASVCP/STP
Reagan, W. J., Irizarry-Rovira, A., Poitout-Belissent, F., Bolliger, A. P., Ramaiah, S. K., Travlos, G., Walker, D., Bounous, D., & Walter, G. (2011).
Best Practices for Evaluation of Bone Marrow in Nonclinical Toxicity Studies. Toxicologic Pathology, 39(2), 435–448. doi:10.1177/0192623310396907 -
Tomlinson, L., Ramaiah, L., Tripathi, N. K., Barlow, V. G., Vitsky, A., Poitout-Belissent, F. M., Bounous, D. L., & Ennulat, D. (2016).
STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies. Toxicologic Pathology, 44(2), 163–172. doi:10.1177/0192623315624165 -
Troth, S. P., Everds, N. E., Siska, W., Knight, B., Lamb, M., & Hutt, J. (2018).
Scientific and Regulatory Policy Committee Points to Consider: Data Visualization for Clinical and Anatomic Pathologists. Toxicologic Pathology, 46(5), 476–487. doi:10.1177/0192623318778733 -
Tuomari, D. L., Kemp, R. K., Sellers, R., Yarrington, J. T., Geoly, F. J., Fouillet, X. L. M., Dybdal, N., & Perry, R. (2007).
Society of Toxicologic Pathology Position Paper on Pathology Image Data: Compliance with 21 CFR Parts 58 and 11. Toxicologic Pathology, 35(3), 450–455. doi:10.1080/01926230701284509 -
Tuomari, D., Elliott, G., Kulwich, B., Yarrington, J., Fouillet, X., Geoly, F., & Long, P. (2004).
Society of Toxicologic Pathology Position on Histopathology Data Collection and Audit Trail: Compliance with 21 CFR Parts 58 and 11. Toxicologic Pathology, 32(1), 122–123. doi:10.1080/01926230490268710