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Results: 1 to 20 of 98

1.

Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models.

Dixit R, Iciek LA, McKeever K, Ryan PC.

Expert Opin Drug Discov. 2010 Jan;5(1):79-94. doi: 10.1517/17460440903443410.

PMID:
22823973
[PubMed]
2.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Serabian MA, Pilaro AM.

Toxicol Pathol. 1999 Jan-Feb;27(1):27-31. Review.

PMID:
10367669
[PubMed - indexed for MEDLINE]
Free Article
3.

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

EFSA GMO Panel Working Group on Animal Feeding Trials.

Food Chem Toxicol. 2008 Mar;46 Suppl 1:S2-70. doi: 10.1016/j.fct.2008.02.008. Epub 2008 Feb 13. Review.

PMID:
18328408
[PubMed - indexed for MEDLINE]
4.

Use of animal models of human disease for nonclinical safety assessment of novel pharmaceuticals.

Morgan SJ, Elangbam CS, Berens S, Janovitz E, Vitsky A, Zabka T, Conour L.

Toxicol Pathol. 2013;41(3):508-18. doi: 10.1177/0192623312457273. Epub 2012 Sep 11.

PMID:
22968286
[PubMed - indexed for MEDLINE]
Free Article
5.

New challenges and opportunities in nonclinical safety testing of biologics.

Baumann A, Flagella K, Forster R, de Haan L, Kronenberg S, Locher M, Richter WF, Theil FP, Todd M.

Regul Toxicol Pharmacol. 2014 Jul;69(2):226-33. doi: 10.1016/j.yrtph.2014.04.005. Epub 2014 Apr 19.

PMID:
24755365
[PubMed - in process]
6.

Preclinical cardiovascular safety evaluations of biologics: optimizing the approach and follow-up.

Hondeghem L, De Clerck F.

BioDrugs. 2012 Oct 1;26(5):275-82. doi: 10.2165/11633490-000000000-00000.

PMID:
22909102
[PubMed - indexed for MEDLINE]
7.

Nonclinical development of biopharmaceuticals.

Baumann A.

Drug Discov Today. 2009 Dec;14(23-24):1112-22. doi: 10.1016/j.drudis.2009.09.013. Epub 2009 Oct 21. Review.

PMID:
19853058
[PubMed - indexed for MEDLINE]
8.

Case study 5. Deconvoluting hyperbilirubinemia: differentiating between hepatotoxicity and reversible inhibition of UGT1A1, MRP2, or OATP1B1 in drug development.

Templeton I, Eichenbaum G, Sane R, Zhou J.

Methods Mol Biol. 2014;1113:471-83. doi: 10.1007/978-1-62703-758-7_22.

PMID:
24523126
[PubMed - in process]
9.

Early development of therapeutic biologics--pharmacokinetics.

Baumann A.

Curr Drug Metab. 2006 Jan;7(1):15-21. Review.

PMID:
16454690
[PubMed - indexed for MEDLINE]
10.

The yin and yang of immunomodulatory biologics: assessing the delicate balance between benefit and risk.

Danilenko DM, Wang H.

Toxicol Pathol. 2012;40(2):272-87. doi: 10.1177/0192623311430237. Epub 2012 Jan 5. Review.

PMID:
22222884
[PubMed - indexed for MEDLINE]
Free Article
11.

The emerging role of pharmacogenomics in biologics.

LacanĂ¡ E, Amur S, Mummanneni P, Zhao H, Frueh FW.

Clin Pharmacol Ther. 2007 Oct;82(4):466-71. Epub 2007 Aug 22. Review.

PMID:
17713469
[PubMed - indexed for MEDLINE]
12.

Nonclinical safety evaluation of biotechnologically derived pharmaceuticals.

Dempster AM.

Biotechnol Annu Rev. 2000;5:221-58. Review.

PMID:
10875002
[PubMed - indexed for MEDLINE]
13.

Metabolites in safety testing.

Robison TW, Jacobs A.

Bioanalysis. 2009 Oct;1(7):1193-200. doi: 10.4155/bio.09.98.

PMID:
21083045
[PubMed - indexed for MEDLINE]
14.

Disposition of biologics.

Brady K, Webster R.

Adv Pharmacol. 2012;63:257-77. doi: 10.1016/B978-0-12-398339-8.00007-0. Review.

PMID:
22776644
[PubMed - indexed for MEDLINE]
15.

Current challenges and opportunities in nonclinical safety testing of biologics.

Kronenberg S, Baumann A, de Haan L, Hinton HJ, Moggs J, Theil FP, Wakefield I, Singer T.

Drug Discov Today. 2013 Dec;18(23-24):1138-43. doi: 10.1016/j.drudis.2013.08.003. Epub 2013 Aug 11.

PMID:
23942260
[PubMed - in process]
16.

Preclinical development strategies for novel gene therapeutic products.

Pilaro AM, Serabian MA.

Toxicol Pathol. 1999 Jan-Feb;27(1):4-7. Review.

PMID:
10367665
[PubMed - indexed for MEDLINE]
Free Article
17.

Macromolecular crowding: chemistry and physics meet biology (Ascona, Switzerland, 10-14 June 2012).

Foffi G, Pastore A, Piazza F, Temussi PA.

Phys Biol. 2013 Aug 2;10(4):040301. [Epub ahead of print]

PMID:
23912807
[PubMed - as supplied by publisher]
18.

Preclinical development of therapeutic biologics.

Baumann A.

Expert Opin Drug Discov. 2008 Mar;3(3):289-97. doi: 10.1517/17460441.3.3.289.

PMID:
23480264
[PubMed]
19.

Challenges and opportunities in absorption, distribution, metabolism, and excretion studies of therapeutic biologics.

Xu X, Vugmeyster Y.

AAPS J. 2012 Dec;14(4):781-91. doi: 10.1208/s12248-012-9388-8. Epub 2012 Aug 4. Review.

PMID:
22864668
[PubMed - indexed for MEDLINE]
Free PMC Article
20.

A clinical development paradigm for cancer vaccines and related biologics.

Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G; Cancer Vaccine Clinical Trial Working Group.

J Immunother. 2007 Jan;30(1):1-15. Review.

PMID:
17198079
[PubMed - indexed for MEDLINE]

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