Finch GL - Search Results

1

Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop.

Buckley LA, Benson K, Davis-Bruno K, Dempster M, Finch GL, Harlow P, Haggerty HG, Hart T, Kinter L, Leighton JK, McNulty J, Roskos L, Saber H, Stauber A, Tabrizi M. Buckley LA, et al. Among authors: finch gl. Int J Toxicol. 2008 Jul-Aug;27(4):303-12. doi: 10.1080/10915810802367016. Int J Toxicol. 2008. PMID: 18821393

2

Carcinogenicity assessments of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations.

Vahle JL, Finch GL, Heidel SM, Hovland DN Jr, Ivens I, Parker S, Ponce RA, Sachs C, Steigerwalt R, Short B, Todd MD. Vahle JL, et al. Among authors: finch gl. Toxicol Pathol. 2010 Jun;38(4):522-53. doi: 10.1177/0192623310368984. Epub 2010 May 14. Toxicol Pathol. 2010. PMID: 20472697 Review.

3

Two-year carcinogenicity study in rats with a nonnucleoside reverse transcriptase inhibitor.

Nambiar PR, Morton D, Dochterman LW, Houle C, Thomford PJ, Fate G, Bailey SA, Finch GL. Nambiar PR, et al. Among authors: finch gl. Toxicol Pathol. 2015 Apr;43(3):354-65. doi: 10.1177/0192623314544381. Epub 2014 Aug 13. Toxicol Pathol. 2015. PMID: 25122632

4

Effects of lersivirine on canine and rodent thyroid function.

Houle CD, Finch GL, Mauthe RJ, Potter DM, Walisser JA, Gardner IB, DeWit RH. Houle CD, et al. Among authors: finch gl. Toxicol Pathol. 2014 Jul;42(5):897-912. doi: 10.1177/0192623313503516. Epub 2013 Oct 16. Toxicol Pathol. 2014. PMID: 24135463

5

Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®).

Ryan AM, Sokolowski SA, Ng CK, Shirai N, Collinge M, Shen AC, Arrington J, Radi Z, Cummings TR, Ploch SA, Stephenson SA, Tripathi NK, Hurst SI, Finch GL, Leach MW. Ryan AM, et al. Among authors: finch gl. Toxicol Pathol. 2014 Oct;42(7):1069-81. doi: 10.1177/0192623313520351. Epub 2014 Mar 6. Toxicol Pathol. 2014. PMID: 24604381

6

Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin(®)).

Hurst S, Ryan AM, Ng CK, McNally JM, Lorello LG, Finch GL, Leach MW, Ploch SA, Fohey JA, Smolarek TA. Hurst S, et al. Among authors: finch gl. BioDrugs. 2014 Oct;28(5):451-9. doi: 10.1007/s40259-014-0103-4. BioDrugs. 2014. PMID: 25001079 Free PMC article.

7

Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab.

Derzi M, Shoieb AM, Ripp SL, Finch GL, Lorello LG, O'Neil SP, Radi Z, Syed J, Thompson MS, Leach MW. Derzi M, et al. Among authors: finch gl. Regul Toxicol Pharmacol. 2020 Apr;112:104587. doi: 10.1016/j.yrtph.2020.104587. Epub 2020 Jan 30. Regul Toxicol Pharmacol. 2020. PMID: 32006671 Free article.

8

Key considerations in the preclinical development of biosimilars.

Bui LA, Hurst S, Finch GL, Ingram B, Jacobs IA, Kirchhoff CF, Ng CK, Ryan AM. Bui LA, et al. Among authors: finch gl. Drug Discov Today. 2015 May;20 Suppl 1:3-15. doi: 10.1016/j.drudis.2015.03.011. Epub 2015 Apr 23. Drug Discov Today. 2015. PMID: 25912284 Review.

9

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.

Jacobs I, Petersel D, Shane LG, Ng CK, Kirchhoff C, Finch G, Lula S. Jacobs I, et al. BioDrugs. 2016 Dec;30(6):489-523. doi: 10.1007/s40259-016-0199-9. BioDrugs. 2016. PMID: 27807766 Free PMC article. Review.

10

Developmental toxicity study of lersivirine in mice.

Cappon GD, Bowman CJ, Campion SN, Chmielewski G, Hurtt ME, Finch GL, Lewis EM. Cappon GD, et al. Among authors: finch gl. Birth Defects Res B Dev Reprod Toxicol. 2012 Jun;95(3):225-30. doi: 10.1002/bdrb.21008. Epub 2012 Mar 22. Birth Defects Res B Dev Reprod Toxicol. 2012. PMID: 22447726

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