{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T13:29:31Z","timestamp":1778592571662,"version":"3.51.4"},"reference-count":37,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2016,11,11]],"date-time":"2016-11-11T00:00:00Z","timestamp":1478822400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Toxicol Pathol"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:p>A number of factors related to study design have the potential to impact clinical pathology test results during the conduct of nonclinical safety studies. A thorough understanding of these factors is paramount in drawing accurate conclusions from clinical pathology data generated during such studies, particularly when attempting to make the distinction between test article and nontest article\u2013related effects. Study design and conduct variables with potential to impact clinical pathology data discussed in this overview include those related to species and test system, animal age, animal care and husbandry practices, fasting, acclimatization periods, effects of transportation and stressors, route of administration, effects of in-life and surgical procedures, influence of study length, timing of blood collections, impact of vehicle\/formulation composition, and some general concepts related to drug class. The material presented here is a summary based on information presented at the 35th Annual Symposium of the Society of Toxicologic Pathology (June 2016), during Symposium Session 2 titled \u201cDeciphering Sources of Variability in Clinical Pathology\u2014It\u2019s Not Just about the Numbers.\u201d<\/jats:p>","DOI":"10.1177\/0192623316677066","type":"journal-article","created":{"date-parts":[[2016,11,11]],"date-time":"2016-11-11T10:32:14Z","timestamp":1478860334000},"page":"288-295","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":24,"title":["Influence of Study Design Variables on Clinical Pathology Data"],"prefix":"10.1177","volume":"45","author":[{"given":"Adam","family":"Aulbach","sequence":"first","affiliation":[{"name":"MPI Research, Mattawan, Michigan, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Provencher","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Sherbrooke, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niraj","family":"Tripathi","sequence":"additional","affiliation":[{"name":"Covance, Madison, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,11,11]]},"reference":[{"key":"bibr1-0192623316677066","volume-title":"Society of Toxicologic Pathology 31st Annual Symposium","author":"Aulbach A.","year":"2012"},{"key":"bibr2-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1111\/j.1939-165X.1992.tb00576.x"},{"key":"bibr3-0192623316677066","first-page":"981","volume-title":"Kirk\u2019s Current Veterinary Therapy XI ed","author":"Chandler M.","year":"1992"},{"key":"bibr4-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623315625330"},{"key":"bibr5-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1038\/cti.2015.14"},{"key":"bibr6-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623312466452"},{"key":"bibr7-0192623316677066","unstructured":"Food and Drug Administration. (2003). Guidance for Industry and Other Stakeholders. Toxicological Principles for the Safety Assessment of Food Ingredients. Redbook 2000: IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies: Center for Food Safety and Applied Nutrition. Accessed October 17, 2016. http:\/\/www.fda.gov\/downloads\/Food\/GuidanceRegulation\/UCM222779."},{"key":"bibr8-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aei160"},{"key":"bibr9-0192623316677066","volume-title":"Society of Toxicology Annual Meeting","author":"Gariepy S.","year":"2015"},{"key":"bibr10-0192623316677066","first-page":"1001","volume-title":"Principles and Methods of Toxicology","author":"Hall R.","year":"2001","edition":"4"},{"key":"bibr11-0192623316677066","doi-asserted-by":"crossref","unstructured":"Harper E. J., Hackett R. M., Wilkinson J., Heaton P. R. (2003). Age-related variations in hematology and plasma biochemical test results in Beagles and Labrador retrievers. J Am Vet Med Assoc 223, 1436\u201342.","DOI":"10.2460\/javma.2003.223.1436"},{"key":"bibr12-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623314522559"},{"key":"bibr13-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2013.05.004"},{"key":"bibr14-0192623316677066","first-page":"66","volume-title":"Canine and Feline Theriogenology","author":"Johnston S. D.","year":"2001"},{"key":"bibr15-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623313510987"},{"key":"bibr16-0192623316677066","doi-asserted-by":"publisher","DOI":"10.2131\/jts.33.537"},{"key":"bibr17-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1093\/ilar.47.4.364"},{"key":"bibr18-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1292\/jvms.15-0502"},{"key":"bibr19-0192623316677066","unstructured":"Organization for Economic Cooperation and Development. (1995). Guidelines for Testing of Chemicals, No. 407\u2013409. Section 4: Health Effects. OECD, Paris, France."},{"key":"bibr20-0192623316677066","first-page":"87","volume-title":"Williams Hematology","author":"Palis J.","year":"2010","edition":"8"},{"key":"bibr21-0192623316677066","first-page":"852","volume-title":"Schalm\u2019s Veterinary Hematology","author":"Provencher Bolliger A.","year":"2010","edition":"6"},{"key":"bibr22-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623314526475"},{"key":"bibr23-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1111\/vcp.12220"},{"key":"bibr24-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1111\/j.1939-165X.2012.00415.x"},{"key":"bibr25-0192623316677066","volume-title":"Society of Toxicology Annual Meeting","author":"Sakai A.","year":"2016"},{"key":"bibr26-0192623316677066","first-page":"2","volume-title":"Nonclinical Vascular Infusion Technology Volume II: The Techniques","author":"Sheehan J.","year":"2014"},{"key":"bibr27-0192623316677066","first-page":"639","volume-title":"Fundamentals of Veterinary Clinical Pathology","author":"Stockham S.","year":"2008","edition":"2"},{"key":"bibr28-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1016\/j.fct.2014.06.028"},{"key":"bibr29-0192623316677066","doi-asserted-by":"publisher","DOI":"10.5402\/2012\/623139"},{"key":"bibr30-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1016\/j.tox.2005.07.023"},{"key":"bibr31-0192623316677066","volume-title":"Society of Toxicology Annual Meeting","author":"Voyer C.","year":"2016"},{"key":"bibr32-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1111\/j.1939-165X.1994.tb00683.x"},{"key":"bibr33-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623392020003217"},{"key":"bibr34-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1538\/expanim.14-0104"},{"key":"bibr35-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1016\/0272-0590(87)90102-3"},{"key":"bibr36-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1111\/j.1939-165X.1988.tb00488.x"},{"key":"bibr37-0192623316677066","doi-asserted-by":"publisher","DOI":"10.1177\/0192623310396512"}],"container-title":["Toxicologic Pathology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0192623316677066","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0192623316677066","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0192623316677066","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T16:38:22Z","timestamp":1777653502000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0192623316677066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,11,11]]},"references-count":37,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,2]]}},"alternative-id":["10.1177\/0192623316677066"],"URL":"https:\/\/doi.org\/10.1177\/0192623316677066","relation":{},"ISSN":["0192-6233","1533-1601"],"issn-type":[{"value":"0192-6233","type":"print"},{"value":"1533-1601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,11,11]]}}}