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3. De novo lipogenesis is essential for platelet production in humans

Author

Kelly, Kenneth L., Reagan, William J., Sonnenberg, Gabriele E., Clasquin, Michelle, Hales, Katherine, Asano, Shoh, Amor, Paul A., Carvajal-Gonzalez, Santos, Shirai, Norimitsu, Matthews, Marcy D., Li, Kelvin W., Hellerstein, Marc K., Vera, Nicholas B., Ross, Trenton T., Cappon, Gregg, Bergman, Arthur, Buckeridge, Clare, Sun, Zhongyuan, Qejvanaj, Enida Ziso, Schmahai, Theodore, Beebe, David, Pfefferkorn, Jeffrey A., and Esler, William P.

Published
2020
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6. Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid™

Author

Sathish, Jean G., primary, Bhatt, Siddhartha, additional, DaSilva, Jamie K., additional, Flynn, Declan, additional, Jenkinson, Stephen, additional, Kalgutkar, Amit S., additional, Liu, Maggie, additional, Manickam, Balasubramanian, additional, Pinkstaff, Jason, additional, Reagan, William J., additional, Shirai, Norimitsu, additional, Shoieb, Ahmed M., additional, Sirivelu, Madhu, additional, Vispute, Saurabh, additional, Vitsky, Allison, additional, Walters, Karen, additional, Wisialowski, Todd A., additional, and Updyke, Lawrence W., additional

Published
2022
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7. sj-pdf-2-ijt-10.1177_10915818221095489 – Supplemental Material for Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid™

Author

Sathish, Jean G., Bhatt, Siddhartha, DaSilva, Jamie K., Flynn, Declan, Jenkinson, Stephen, Kalgutkar, Amit S., Liu, Maggie, Manickam, Balasubramanian, Pinkstaff, Jason, Reagan, William J., Shirai, Norimitsu, Shoieb, Ahmed M., Sirivelu, Madhu, Vispute, Saurabh, Vitsky, Allison, Walters, Karen, Wisialowski, Todd A., and Updyke, Lawrence W.

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-pdf-2-ijt-10.1177_10915818221095489 for Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid™ by Jean G. Sathish, Siddhartha Bhatt, Jamie K. DaSilva, Declan Flynn, Stephen Jenkinson, Amit S. Kalgutkar, Maggie Liu, Balasubramanian Manickam, Jason Pinkstaff, William J. Reagan, Norimitsu Shirai, Ahmed M. Shoieb, Madhu Sirivelu, Saurabh Vispute, Allison Vitsky, Karen Walters, Todd A. Wisialowski and Lawrence W. Updyke in International Journal of Toxicology

Published
2022
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23. Supplemental Material, DS1_TPX_10.1177_0192623318772501 - Effects of Monoclonal Antibodies against Nerve Growth Factor on Healthy Bone and Joint Tissues in Mice, Rats, and Monkeys: Histopathologic, Biomarker, and Microcomputed Tomographic Assessments

Author

Gropp, Kathryn E., Carlson, Cathy S., Evans, Mark G., Cedo M. Bagi, Reagan, William J., Hurst, Susan I., Shelton, David L., and Zorbas, Mark A.

Subjects
FOS: Clinical medicine, humanities, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, DS1_TPX_10.1177_0192623318772501 for Effects of Monoclonal Antibodies against Nerve Growth Factor on Healthy Bone and Joint Tissues in Mice, Rats, and Monkeys: Histopathologic, Biomarker, and Microcomputed Tomographic Assessments by Kathryn E. Gropp, Cathy S. Carlson, Mark G. Evans, Cedo M. Bagi, William J. Reagan, Susan I. Hurst, David L. Shelton, and Mark A. Zorbas in Toxicologic Pathology

Published
2018
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29. Assessment of Cardiac Troponin I Responses in Nonhuman Primates during Restraint, Blood Collection, and Dosing in Preclinical Safety Studies.

Author

Reagan, William J., Barnes, Robert, Harris, Peter, Summers, Sandy, Lopes, Sarah, Stubbs, Makeida, Blackwell, David, and Steidl-Nichols, Jill

Subjects
*TROPONIN I, *BIOMARKERS, *KRA
Abstract

Limited information has been published on the use of cardiac troponin I (cTnI) as a biomarker of cardiac injury in monkeys. The purpose of these studies was to characterize the cTnI response seen in cynomolgus macaques during routine dosing and blood collection procedures typically used in preclinical safety studies and to better understand the pathogenesis of this response. We measured cTnI using two different methods, the Siemens Immulite cTnI assay and the more sensitive Siemens Troponin I-Ultra assay. We were able to demonstrate that after oral, subcutaneous, or intravenous dosing of common vehicles, as well as serial chair restraint for venipuncture blood collection, that minimal to mild transient increases in cTnI could be detected in monkeys with both assays. cTnI values typically peaked at 2, 3, 4, or 6 hr after sham dosing and returned to baseline at 22 or 24 hr. In addition, marked increases in heart rate (HR) and blood pressure (BP) occurred in monkeys during the restraint procedures, which likely initiated the cTnI release in these animals. Monkeys that were very well acclimated to the chairing procedures and had vascular access ports for blood sampling did not have marked increases in HRs and BP or increases in cTnI. [ABSTRACT FROM AUTHOR]

Published
2017
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31. Summary of the HESI Consortium Studies Exploring Circulating Inhibin B as a Potential Biomarker of Testis Damage in the Rat

Author

Chapin, Robert, primary, Weinbauer, Gerhard, additional, Thibodeau, Michael S., additional, Sonee, Manisha, additional, Saldutti, Louise Parks, additional, Reagan, William J., additional, Potter, David, additional, Moffit, Jeffrey S., additional, Laffan, Susan, additional, Kim, James H., additional, Goldstein, Richard A., additional, Erdos, Zoltan, additional, Enright, Brian P., additional, Coulson, Michelle, additional, and Breslin, William J., additional

Published
2013
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32. Analytic Evaluation of a Human ELISA Kit for Measurement of Inhibin B in Rat Samples

Author

Coulson, Michelle, primary, Bickerton, Sue, additional, Betts, Catherine J, additional, Jacobsen, Matt, additional, Stewart, Jane, additional, Chapin, Robert E., additional, Reagan, William J., additional, Alvey, James, additional, Erdos, Zoltan, additional, Saldutti, Louise Parks, additional, Sonee, Manisha, additional, Bogdan, Nancy, additional, Singer, Monica, additional, Vinken, Petra, additional, Barlow, Valerie, additional, Czajkowski, Karen, additional, and Kim, James H., additional

Published
2013
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34. Response letter from Clinical Pathology Interest Group of the Society of Toxicologic Pathology (STP) for manuscript entitled International recommendations for training future toxicologic pathologists participating in regulatory-type, nonclinical toxicity studies by Bolon et al.

Author

Tripathi, Niraj K., primary, Schultze, A. Eric, additional, Pearson, Renee C., additional, Everds, Nancy E., additional, Elliott, Glenn S., additional, Ramaiah, Lila, additional, Wells, Monique Y., additional, Latimer, Kenneth S., additional, Walter, Gail L., additional, Katavolos, Paula, additional, Collins, Nathanial D., additional, Tarrant, Jacqueline, additional, Walker, Dana B., additional, Topper, Michael J., additional, Jordan, Holly L., additional, O’Rourke, Laurie G., additional, Guilpin, Valerie B., additional, Brockus, Charles W., additional, Wilcox, Angela L., additional, Clemo, Frances A., additional, Smith, Graham S., additional, Reagan, William J., additional, and McCartney, Jeffrey E., additional

Published
2013
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35. Evaluation of urinary corticosterone as a biomarker of stress in rats using fenitrothion as a chemical stressor.

Author

Lapointe, Jean-Martin, Snyder, Patricia A., and Reagan, William J.

Subjects
CORTICOSTERONE, BIOMARKERS, FENITROTHION, BODY weight, DRUG toxicity, IMMUNOSUPPRESSION
Abstract

Regulatory guidelines for pharmaceutical toxicity studies recommend using one dose near the maximum tolerated. At that level significant toxicities may occur, leading to systemic stress and secondary immune suppression which can be difficult to differentiate from a primary drug effect. Therefore, there is a need for a biomarker of stress applicable to toxicity studies. This study evaluated urinary corticosterone as a biomarker, using as a pharmacologic stressor fenitrothion, which was previously shown not to cause primary immune suppression. Rats were administered fenitrothion orally at 20 and 30 mg/kg daily for 2 or 8 days, with matched vehicle controls (n = 6/group). Urine was collected for 6 and 24 h, before treatment and on Day 2 and Day 8. Urine was assayed for corticosterone, separately for the first 6 h of collection and for the whole 24 h sample. Animals were euthanized on Day 3 or Day 9 and lymphoid tissue samples were collected, weighed and examined histologically. Treated rats showed neurologic signs following treatment. Findings also included time- and dose-dependent decreases in body weight and spleen and thymus weight decreases supra-proportional to body weight on Day 9. Histologic changes were mild at a dose of 20 mg/kg, but significant at 30 mg/kg, consisting of lymphocytolysis at Day 3 and lymphoid depletion at Day 9. Urine corticosterone levels were increased on Day 2 and Day 8, in the 6-h samples, but not the 24-h ones, at both dose levels. Based on the results, urine corticosterone appears to be a sensitive biomarker of systemic stress caused by fenitrothion. Other chemical stressors should be evaluated in a similar manner in order to fully validate urine corticosterone measurement as a stress biomarker. [ABSTRACT FROM PUBLISHER]

Published
2016
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