Halpern W - Search Results

1

Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies.

Vidal JD, Colman K, Bhaskaran M, de Rijk E, Fegley D, Halpern W, Jacob B, Kandori H, Manickam B, McKeag S, Parker GA, Regan KS, Sefing B, Thibodeau M, Vemireddi V, Werner J, Zalewska A. Vidal JD, et al. Among authors: halpern w. Toxicol Pathol. 2021 Jul;49(5):977-989. doi: 10.1177/0192623321990631. Epub 2021 Mar 4. Toxicol Pathol. 2021. PMID: 33661059 Review.

2

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.

Halpern WG, Ameri M, Bowman CJ, Elwell MR, Mirsky ML, Oliver J, Regan KS, Remick AK, Sutherland VL, Thompson KE, Tremblay C, Yoshida M, Tomlinson L. Halpern WG, et al. Toxicol Pathol. 2016 Aug;44(6):789-809. doi: 10.1177/0192623316650052. Epub 2016 May 27. Toxicol Pathol. 2016. PMID: 27235322 Free PMC article.

3

Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.

Hukkanen RR, Halpern WG, Vidal JD. Hukkanen RR, et al. Toxicol Pathol. 2016 Oct;44(7):927-30. doi: 10.1177/0192623316656416. Epub 2016 Jun 29. Toxicol Pathol. 2016. PMID: 27357192

4

Use of Severity Grades to Characterize Histopathologic Changes.

Schafer KA, Eighmy J, Fikes JD, Halpern WG, Hukkanen RR, Long GG, Meseck EK, Patrick DJ, Thibodeau MS, Wood CE, Francke S. Schafer KA, et al. Toxicol Pathol. 2018 Apr;46(3):256-265. doi: 10.1177/0192623318761348. Epub 2018 Mar 12. Toxicol Pathol. 2018. PMID: 29529947

5

Atypical presentation and pathogenesis of a macaque lymphocryptoviral-associated B-cell lymphoma in a cynomolgus monkey.

Adedeji AO, Vemireddi V, Tripathi N, Durinck S, Maher JM, Vucic D, Halpern W. Adedeji AO, et al. Among authors: halpern w. Vet Clin Pathol. 2020 Mar;49(1):130-136. doi: 10.1111/vcp.12822. Epub 2020 Feb 3. Vet Clin Pathol. 2020. PMID: 32009251

6

Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices.

Morford LL, Bowman CJ, Blanset DL, Bøgh IB, Chellman GJ, Halpern WG, Weinbauer GF, Coogan TP. Morford LL, et al. Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):359-80. doi: 10.1002/bdrb.20305. Epub 2011 Jul 18. Birth Defects Res B Dev Reprod Toxicol. 2011. PMID: 21770023 Review.

7

Current Trends of Practices in Nonclinical Toxicology: An Industry Survey.

Authier S, Brock WJ, Halpern W, Harris SN, Jones D, McGovern T, McGovern PD, Pugsley MK. Authier S, et al. Among authors: halpern w. Int J Toxicol. 2021 Dec;40(6):487-505. doi: 10.1177/10915818211043435. Epub 2021 Sep 25. Int J Toxicol. 2021. PMID: 34569357

8

Neutropenia in Cynomolgus Monkeys With Anti-Drug Antibodies Associated With Administration of Afucosylated Humanized Monoclonal Antibodies.

Adedeji AO, Zhong F, Getz JA, Zhong Z, Halpern W. Adedeji AO, et al. Among authors: halpern w. Toxicol Pathol. 2022 Dec;50(8):910-919. doi: 10.1177/01926233221131510. Epub 2022 Nov 3. Toxicol Pathol. 2022. PMID: 36329562 Free PMC article.

9

Use of tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: history, experience, methodology, and future directions.

Leach MW, Halpern WG, Johnson CW, Rojko JL, MacLachlan TK, Chan CM, Galbreath EJ, Ndifor AM, Blanset DL, Polack E, Cavagnaro JA. Leach MW, et al. Among authors: halpern wg. Toxicol Pathol. 2010 Dec;38(7):1138-66. doi: 10.1177/0192623310382559. Epub 2010 Oct 6. Toxicol Pathol. 2010. PMID: 20926828

10

Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals.

Rocca M, Morford LL, Blanset DL, Halpern WG, Cavagnaro J, Bowman CJ. Rocca M, et al. Regul Toxicol Pharmacol. 2018 Oct;98:69-79. doi: 10.1016/j.yrtph.2018.07.006. Epub 2018 Jul 24. Regul Toxicol Pharmacol. 2018. PMID: 30009863 Review.

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