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Best Practices & Points to Consider Papers

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Best Practices Card

Data Interpretation/Management

  • 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


  • 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
Study Design

  • Bregman, C. L., Adler, R. R., Morton, D. G., Regan, K. S., & Yano, B. L. (2003).
    Recommended Tissue List for Histopathologic Examination in Repeat-Dose Toxicity and Carcinogenicity Studies: A Proposal of the Society of Toxicologic Pathology (STP). Toxicologic Pathology, 31(2), 252–253. doi:10.1080/01926230390183751

  • Crissman, J. W., Goodman, D. G., Hildebrandt, P. K., Maronpot, R. R., Prater, D. A., Riley, J. H., Seaman, W. J., & Thake, D. C. (2004).
    Best Practices Guideline: Toxicologic Histopathology. Toxicologic Pathology, 32(1), 126–131. doi:10.1080/01926230490268756

  • Everds, N. E., Snyder, P. W., Bailey, K. L., Bolon, B., Creasy, D. M., Foley, G. L., Rosol, T. J., & Sellers, T. (2013).
    Interpreting Stress Responses during Routine Toxicity Studies: A Review of the Biology, Impact, and Assessment. Toxicologic Pathology, 41(4), 560–614. doi:10.1177/0192623312466452

  • Halpern, W. G., Ameri, M., Bowman, C. J., Elwell, M. R., Mirsky, M. L., Oliver, J., Regan, K. S., Remick, A. K., Sutherland, V. L., Thompson, K. E., Tremblay, C., Yoshida, M., & Tomlinson, L. (2016).
    Scientific and Regulatory Policy Committee Points to Consider Review:Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development. Toxicologic Pathology, 44(6), 789–809. doi:10.1177/0192623316650052

  • Hukkanen, R. R., Dybdal, N., Tripathi, N., Turner, P. V., & Troth, S. P. (2019).
    Scientific and Regulatory Policy Committee Points to Consider*: The Toxicologic Pathologist’s Role in the 3Rs. Toxicologic Pathology, 47(7), 789–798. doi:10.1177/0192623319859261

  • Long, R. E., Smith, A., Machotka, S. V., Chlipala, E., Cann, J., Knight, B., Kawano, Y., Ellin, J., & Lowe, A. (2013).
    Scientific and Regulatory Policy Committee (SRPC) Paper: Validation of Digital Pathology Systems in the Regulated Nonclinical Environment. Toxicologic Pathology, 41(1), 115–124. doi:10.1177/0192623312451162

  • Morgan, S. J., Elangbam, C. S., Berens, S., Janovitz, E., Vitsky, A., Zabka, T., & Laura Conour (2013).
    Use of Animal Models of Human Disease for Nonclinical Safety Assessment of Novel Pharmaceuticals. Toxicologic Pathology, 41(3), 508–518. doi:10.1177/0192623312457273

  • Nold, J. B., Keenan, K. P., Nyska, A., & Cartwright, M. E. (2001).
    Society of Toxicologic Pathology Position Paper: Diet as a Variable in Rodent Toxicology and Carcinogenicity Studies. Toxicologic Pathology, 29(5), 585–586. doi:10.1080/019262301317226393

  • Perry, R., Farris, G., Bienvenu, J., Dean, Jr, C., Foley, G., Mahrt, C., & Short, B. (2013).
    Society of Toxicologic Pathology Position Paper on Best Practices on Recovery Studies: The Role of the Anatomic Pathologist. Toxicologic Pathology, 41(8), 1159–1169. doi:10.1177/0192623313481513

  • Sellers, R. S., Morton, D., Michael, B., Roome, N., Johnson, J . K., Yano, B. Y., Perry, R., & Schafer, K. (2007).
    Society of Toxicologic Pathology Position Paper: Organ Weight Recommendations for Toxicology Studies. Toxicologic Pathology, 35(5), 751–755. doi:10.1080/01926230701595300

  • Sellers, R. S., Nelson, K., Bennet, B., Wolf, J., Tripathi, N., Chamanza, R., Lepage, M. P., Adkins, K., Laurent, S., & Troth, S. P. (2020).
    Scientific and Regulatory Policy Committee Points to Consider*: Approaches to the Conduct and Interpretation of Vaccine Safety Studies for Clinical and Anatomic Pathologists. Toxicologic Pathology, 48(2), 257–276. doi:10.1177/0192623319875085

  • Tomlinson, L., Boone, L. I., Ramaiah, L., Penraat, K. A., von Beust, B. R., Ameri, M., Poitout‐Belissent, F. M., Weingand, K., Workman, H. C., Aulbach, A. D., Meyer, D. J., Brown, D. E., MacNeill, A. L., Bolliger, A. P., & Bounous, D. L. (2013).
    Best Practices for Veterinary Toxicologic Clinical Pathology, with Emphasis on the Pharmaceutical and Biotechnology Industries. Veterinary Clinical Pathology, 42(3), 252–269. doi:10.1111/vcp.12059

  • Best practice paper from ASVCP/STP Clinical Pathology in Carcinogenicity Studies Working Group
    Young, J. K., Hall, R. L., O’Brien, P., Strauss, V., & Vahle, J. L. (2011).
    Best Practices for Clinical Pathology Testing in Carcinogenicity Studies. Toxicologic Pathology, 39(2), 429-434. doi:10.1177/0192623310396512
Study Reports/Peer Review

  • Fikes, J. D., Patrick, D. J., Francke, S., Frazier, K. S., Reindel, J. F., Romeike, A., Spaet, R. H., Tomlinson, L., 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. Toxicologic Pathology, 43(7), 907–914. doi:10.1177/0192623315596382

  • Morton, D., Kemp, R. K., Francke-Carroll, S., Jensen*, K., McCartney, J., Monticello, T. M., Perry, R., Pulido, O., Roome, N., Schafer, K., Sellers, R., & Snyder, P. W. (2006).
    Best Practices for Reporting Pathology Interpretations within GLP Toxicology Studies. Toxicologic Pathology, 34(6), 1118–1127. doi:10.1080/01926230601034624

  • Morton, D., Sellers, R. S., Barale-Thomas, E., Bolon, B., George, C., Hardisty, J. F., Irizarry, A., McKay, J. S., Odin, M., & Teranishi, M.F. (2010).
    Recommendations for Pathology Peer Review. Toxicologic Pathology, 38(7), 1118–1127. doi:10.1177/0192623310383991

  • STP Regulatory Affairs Committee. (1997).
    Documentation of Pathology Peer Review. Toxicologic Pathology, 25(6), 655–655. doi:10.1177/019262339702500624
System⁄Organ Specific

  • Andersson, H., Rehm, S., Stanislaus, D., & Wood, C. E. (2013).
    Scientific and Regulatory Policy Committee (SRPC) Paper: Assessment of Circulating Hormones in Nonclinical Toxicity Studies III. Female Reproductive Hormones. Toxicologic Pathology, 41(6), 921–934. doi:10.1177/0192623312466959

  • Ad Hoc Working Group of the STP Scientific and Regulatory Policy Committee
    Bolon, B., Garman, R., Jensen, K., Krinke, G., & Stuart, B. (2006).
    STP Position Paper: A ‘Best Practices’ Approach to Neuropathologic Assessment in Developmental Neurotoxicity Testing—for Today. Toxicologic Pathology, 34(3), 296–313. doi:10.1080/01926230600713269

  • Bolon, B., Garman, R. H., Pardo, I. D., Jensen, K., Sills, R. C., Roulois, A., Radovsky, A., Bradley, A., Andrews-Jones, L., Butt, M., & Gumprecht, L. (2013).
    STP Position Paper: Recommended Practices for Sampling and Processing the Nervous System (Brain, Spinal Cord, Nerve, and Eye) during Nonclinical General Toxicity Studies. Toxicologic Pathology, 41(7), 1028–1048. doi:10.1177/0192623312474865

  • Bolon, B., Krinke, G., Butt, M., Rao, D. B., Pardo, I. D., Jortner, B. S., Garman, R. H., Jensen, K., Andrews-Jones, L., Morrison, J. P., Sharma, A. K., & Thibodeau, M. S. (2008).
    STP Position Paper: Recommended Best Practices for Sampling, Processing, and Analysis of the Peripheral Nervous System (Nerves and Somatic and Autonomic Ganglia) during Nonclinical Toxicity Studies. Toxicologic Pathology, 46(4), 372–402. doi:10.1177/0192623318772484

  • Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology
    Boone, L., Meyer, D., Cusick, P., Ennualt, D., Bolliger, A. P., Everds, N., Meador, V., Elliott, D., Honor, D., Bounous, D., & Jordan, H. (2008).
    Selection and Interpretation of Clinical Pathology Indicators of Hepatic Injury in Preclinical Studies. Veterinary Clinical Pathology, 34(3), 182–188. doi:10.1111/j.1939-165X.2005.tb00041.x

  • Chapin, R. E., & Creasy, D. M. (2012).
    Assessment of Circulating Hormones in Regulatory Toxicity Studies II. Male Reproductive Hormones. Toxicologic Pathology, 40(7), 1063–1078. doi:10.1177/0192623312443321

  • STP Immunotoxicology Working Group
    Haley, P., Perry, R., Ennulat, D., Frame, S., Johnson, C., Lapointe, J. M., Nyska, A., Snyder, P. W., Walker, D. & Walter, G. (2005).
    STP Position Paper: Best Practice Guideline for the Routine Pathology Evaluation of the Immune System. Toxicologic Pathology, 33(3), 404–407. doi:10.1080/01926230590934304

  • Lanning, L. L., Creasy, D. M., Chapin, R. E., Mann, P. C., Barlow, N. J., Regan, K. S., & Goodman, D. G. (2002).
    Recommended Approaches for the Evaluation of Testicular and Epididymal Toxicity. Toxicologic Pathology, 30(4), 507–520. doi:10.1080/01926230290105695

  • Nikula, K. J., McCartney, J. E., McGovern, T., Miller, G. K., Odin, M. Pino, M. V., & Reed, M. D. (2014).
    STP Position Paper: Interpreting the Significance of Increased Alveolar Macrophages in Rodents Following Inhalation of Pharmaceutical Materials. Toxicologic Pathology, 42(3), 472–486. doi:10.1177/0192623313507003

  • STP Ovary Evaluation Working Group
    Regan, K., Cline, J. M., Creasy, D., Davis, B., Foley, G. L., Lanning, L., Latendresse, J. R., Makris, S., Morton, D., Rehm, S., & Stebbins, K. (2005).
    STP Position Paper: Ovarian Follicular Counting in the Assessment of Rodent Reproductive Toxicity. Toxicologic Pathology, 33(3), 409–412. doi:10.1080/01926230490515355

  • Schafer, K. A., Eighmy, J., Fikes, J. D., Halpern, W. G., Hukkanen, R. R., Long, G. G., Meseck, E. K., Patrick, D. J., Thibodeau, M. S., Wood, C. E., & Francke, S. (2008).
    Use of Severity Grades to Characterize Histopathologic Changes. Toxicologic Pathology, 46(3), 256–265. doi:10.1177/0192623318761348

  • Stanislaus, D., Andersson, H., Chapin, R., Creasy, D., Ferguson, D., Gilbert, M., Rosol, T. J., Boyce, R. W., & Wood, C. E. (2012).
    Society of Toxicologic Pathology Position Paper: Review Series: Assessment of Circulating Hormones in Nonclinical Toxicity Studies: General Concepts and Considerations. Toxicologic Pathology, 40(6), 943–950. doi:10.1177/0192623312444622
Training

  • International Federation of Societies of Toxicologic Pathologists (IFSTP)
    Bolon, B., Barale-Thomas, E., Bradley, A., Ettlin, R. A., Franchi, C. A. S., George, C., Giusti, A. M., Hall, R., Jacobsen, M., Konishi, Y., Ledieu, D., Morton, D., Park, J. H., Scudamore, C. L., Tsuda, H., Vijayasarathi, S. K., & Wijnands, M. V. W. (2010).
    International Recommendations for Training Future Toxicologic Pathologists Participating in Regulatory-type, Nonclinical Toxicity Studies. Toxicologic Pathology, 38(6), 984–992. doi:10.1177/0192623310378137

Draft position papers can be reviewed by STP members on the STP Members’ site.

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