Heidel SM - Search Results

1

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: heidel sm. Toxicol Pathol. 2010 Jun;38(4):522-53. doi: 10.1177/0192623310368984. Epub 2010 May 14. Toxicol Pathol. 2010. PMID: 20472697 Review.

2

Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?

Clarke J, Hurst C, Martin P, Vahle J, Ponce R, Mounho B, Heidel S, Andrews L, Reynolds T, Cavagnaro J. Clarke J, et al. Regul Toxicol Pharmacol. 2008 Feb;50(1):2-22. doi: 10.1016/j.yrtph.2007.08.001. Epub 2007 Aug 24. Regul Toxicol Pharmacol. 2008. PMID: 17998153 Review.

3

High molecular weight polyethylene glycol cellular distribution and PEG-associated cytoplasmic vacuolation is molecular weight dependent and does not require conjugation to proteins.

Rudmann DG, Alston JT, Hanson JC, Heidel S. Rudmann DG, et al. Toxicol Pathol. 2013;41(7):970-83. doi: 10.1177/0192623312474726. Epub 2013 Jun 20. Toxicol Pathol. 2013. PMID: 23788571

4

Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use.

Sewell F, Chapman K, Couch J, Dempster M, Heidel S, Loberg L, Maier C, Maclachlan TK, Todd M, van der Laan JW. Sewell F, et al. MAbs. 2017 Jul;9(5):742-755. doi: 10.1080/19420862.2017.1324376. Epub 2017 May 5. MAbs. 2017. PMID: 28475417 Free PMC article.

5

Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance.

Nakazawa T, Kurokawa M, Kimura K, Wakata A, Hisada S, Inoue T, Sagami F, Heidel SM, Kawakami K, Shinoda K, Onodera H, Kumagai Y, Ohno Y, Kawamura N, Yamazaki T, Inoue T. Nakazawa T, et al. Among authors: heidel sm. J Toxicol Sci. 2008 Aug;33(3):277-82. doi: 10.2131/jts.33.277. J Toxicol Sci. 2008. PMID: 18670158 Free article. Review.

6

A 6-month inhalation study to characterize the toxicity, pharmacokinetics, and pharmacodynamics of human insulin inhalation powder (HIIP) in beagle dogs.

Vick A, Wolff R, Koester A, Reams R, Deaver DR, Heidel S. Vick A, et al. J Aerosol Med. 2007 Summer;20(2):112-26. doi: 10.1089/jam.2007.0586. J Aerosol Med. 2007. PMID: 17536950 Clinical Trial.

7

Cytochrome P4501B1 mediates induction of bone marrow cytotoxicity and preleukemia cells in mice treated with 7,12-dimethylbenz[a]anthracene.

Heidel SM, MacWilliams PS, Baird WM, Dashwood WM, Buters JT, Gonzalez FJ, Larsen MC, Czuprynski CJ, Jefcoate CR. Heidel SM, et al. Cancer Res. 2000 Jul 1;60(13):3454-60. Cancer Res. 2000. PMID: 10910056

8

Bone marrow stromal cell cytochrome P4501B1 is required for pre-B cell apoptosis induced by 7,12-dimethylbenz[a]anthracene.

Heidel SM, Holston K, Buters JT, Gonzalez FJ, Jefcoate CR, Czupyrynski CJ. Heidel SM, et al. Mol Pharmacol. 1999 Dec;56(6):1317-23. doi: 10.1124/mol.56.6.1317. Mol Pharmacol. 1999. PMID: 10570060

9

Bone marrow stromal cells constitutively express high levels of cytochrome P4501B1 that metabolize 7,12-dimethylbenz[a]anthracene.

Heidel SM, Czuprynski CJ, Jefcoate CR. Heidel SM, et al. Mol Pharmacol. 1998 Dec;54(6):1000-6. doi: 10.1124/mol.54.6.1000. Mol Pharmacol. 1998. PMID: 9855628

10

Expression of human chromosome 2 ornithine decarboxylase gene in ornithine decarboxylase-deficient Chinese hamster ovary cells.

Hsieh JT, Denning MF, Heidel SM, Verma AK. Hsieh JT, et al. Among authors: heidel sm. Cancer Res. 1990 Apr 15;50(8):2239-44. Cancer Res. 1990. PMID: 2317811

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