Milton M - Search Results

1

The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies.

Muller PY, Milton M, Lloyd P, Sims J, Brennan FR. Muller PY, et al. Among authors: milton m. Curr Opin Biotechnol. 2009 Dec;20(6):722-9. doi: 10.1016/j.copbio.2009.10.013. Epub 2009 Nov 5. Curr Opin Biotechnol. 2009. PMID: 19896825 Review.

2

The determination and interpretation of the therapeutic index in drug development.

Muller PY, Milton MN. Muller PY, et al. Nat Rev Drug Discov. 2012 Oct;11(10):751-61. doi: 10.1038/nrd3801. Epub 2012 Aug 31. Nat Rev Drug Discov. 2012. PMID: 22935759 Review.

3

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.

Brennan FR, Baumann A, Blaich G, de Haan L, Fagg R, Kiessling A, Kronenberg S, Locher M, Milton M, Tibbitts J, Ulrich P, Weir L. Brennan FR, et al. Among authors: milton m. Regul Toxicol Pharmacol. 2015 Oct;73(1):265-75. doi: 10.1016/j.yrtph.2015.07.019. Epub 2015 Jul 26. Regul Toxicol Pharmacol. 2015. PMID: 26219199

4

Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.

Brennan FR, Andrews L, Arulanandam AR, Blumel J, Fikes J, Grimaldi C, Lansita J, Loberg LI, MacLachlan T, Milton M, Parker S, Tibbitts J, Wolf J, Allamneni KP. Brennan FR, et al. Among authors: milton m. Regul Toxicol Pharmacol. 2018 Oct;98:98-107. doi: 10.1016/j.yrtph.2018.07.009. Epub 2018 Jul 17. Regul Toxicol Pharmacol. 2018. PMID: 30026135

5

Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial.

Horvath C, Andrews L, Baumann A, Black L, Blanset D, Cavagnaro J, Hastings KL, Hutto DL, MacLachlan TK, Milton M, Reynolds T, Roberts S, Rogge M, Sims J, Treacy G, Warner G, Green JD. Horvath C, et al. Among authors: milton m. Nat Rev Immunol. 2012 Oct;12(10):740; author reply 740. doi: 10.1038/nri3192-c1. Epub 2012 Aug 31. Nat Rev Immunol. 2012. PMID: 22941443 No abstract available.

6

Two Case Studies on How Study Designs Can Be Made More Informative Using Modeling and Simulation Approaches.

Lowe PJ, Fink M, Milton MN. Lowe PJ, et al. Among authors: milton mn. Clin Pharmacol Ther. 2017 Dec;102(6):908-911. doi: 10.1002/cpt.867. Epub 2017 Sep 25. Clin Pharmacol Ther. 2017. PMID: 28944961

7

Models and Approaches Describing the Metabolism, Transport, and Toxicity of Drugs Administered by the Ocular Route.

Dumouchel JL, Chemuturi N, Milton MN, Camenisch G, Chastain J, Walles M, Sasseville V, Gunduz M, Iyer GR, Argikar UA. Dumouchel JL, et al. Among authors: milton mn. Drug Metab Dispos. 2018 Nov;46(11):1670-1683. doi: 10.1124/dmd.118.082974. Epub 2018 Aug 15. Drug Metab Dispos. 2018. PMID: 30111625 Review.

8

Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics.

de Zafra CLZ, Sasseville VG, Matsumoto S, Freichel C, Milton M, MacLachlan TK, Farman C, Raymond I, Gupta S, Newton R, Atzpodien EA, Thackaberry EA. de Zafra CLZ, et al. Among authors: milton m. Regul Toxicol Pharmacol. 2017 Jun;86:221-230. doi: 10.1016/j.yrtph.2017.03.013. Epub 2017 Mar 16. Regul Toxicol Pharmacol. 2017. PMID: 28322894

9

The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development.

Milton MN, Horvath CJ. Milton MN, et al. Toxicol Pathol. 2009 Apr;37(3):363-71. doi: 10.1177/0192623309332997. Epub 2009 Feb 26. Toxicol Pathol. 2009. PMID: 19246571 No abstract available.

10

The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event?

Horvath CJ, Milton MN. Horvath CJ, et al. Toxicol Pathol. 2009 Apr;37(3):372-83. doi: 10.1177/0192623309332986. Epub 2009 Feb 24. Toxicol Pathol. 2009. PMID: 19244218 No abstract available.

Save citations to file

Email citations

Send citations to clipboard

Add to Collections

Add to My Bibliography

Create a file for external citation management software

Your saved search

Your RSS Feed

My NCBI Filters

Text availability

Article attribute

Article type

Publication date

152 results

Search Page