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Items: 1 to 20 of 132

1.

Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies.

Chapman K, Chivers S, Gliddon D, Mitchell D, Robinson S, Sangster T, Sparrow S, Spooner N, Wilson A.

Drug Discov Today. 2014 May;19(5):528-32. doi: 10.1016/j.drudis.2014.01.002. Epub 2014 Jan 18. Review.

2.

Exploratory toxicology as an integrated part of drug discovery. Part II: Screening strategies.

Hornberg JJ, Laursen M, Brenden N, Persson M, Thougaard AV, Toft DB, Mow T.

Drug Discov Today. 2014 Aug;19(8):1137-44. doi: 10.1016/j.drudis.2013.12.009. Epub 2013 Dec 25. Review.

PMID:
24374152
3.

Exploratory toxicology as an integrated part of drug discovery. Part I: Why and how.

Hornberg JJ, Laursen M, Brenden N, Persson M, Thougaard AV, Toft DB, Mow T.

Drug Discov Today. 2014 Aug;19(8):1131-6. doi: 10.1016/j.drudis.2013.12.008. Epub 2013 Dec 22. Review.

PMID:
24368175
4.

Meeting report: metabolites in safety testing (MIST) symposium-safety assessment of human metabolites: what's REALLY necessary to ascertain exposure coverage in safety tests?

Gao H, Jacobs A, White RE, Booth BP, Obach RS.

AAPS J. 2013 Oct;15(4):970-3. doi: 10.1208/s12248-013-9502-6. Epub 2013 Jul 3.

5.

Drug development and nonclinical to clinical translational databases: past and current efforts.

Monticello TM.

Toxicol Pathol. 2015 Jan;43(1):57-61. doi: 10.1177/0192623314557189. Epub 2014 Nov 10. Review.

PMID:
25389276
6.

Nonclinical Safety and Toxicology.

Stark C, Steger-Hartmann T.

Handb Exp Pharmacol. 2016;232:261-83. Review.

PMID:
26489827
7.

Validation of a bioanalytical method using capillary microsampling of 8 µl plasma samples: application to a toxicokinetic study in mice.

Jonsson O, Villar RP, Nilsson LB, Eriksson M, Königsson K.

Bioanalysis. 2012 Aug;4(16):1989-98. doi: 10.4155/bio.12.177.

PMID:
22946915
8.

The application of capillary microsampling in GLP toxicology studies.

Verhaeghe T, Dillen L, Stieltjes H, Zwart L, Feyen B, Diels L, Vroman A, Timmerman P.

Bioanalysis. 2017 Apr;9(7):531-540. doi: 10.4155/bio-2016-0297. Epub 2017 Mar 16.

PMID:
28300424
9.

Beyond the safety assessment of drug-mediated changes in the QT interval... what's next?

Pugsley MK, Authier S, Towart R, Gallacher DJ, Curtis MJ.

J Pharmacol Toxicol Methods. 2009 Jul-Aug;60(1):24-7. doi: 10.1016/j.vascn.2009.07.001. Epub 2009 Jul 15.

PMID:
19616107
10.

Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals.

Buckley LA, Chapman K, Burns-Naas LA, Todd MD, Martin PL, Lansita JA.

Int J Toxicol. 2011 Oct;30(5):583-90. doi: 10.1177/1091581811415875. Review.

PMID:
22013138
11.

Regulatory affairs issues and legal ontologies in drug development.

Munteanu CR, Dorado J, Matei-Ilfoveanu I, Nita SA.

Front Biosci (Elite Ed). 2013 Jan 1;5:446-60. Review.

PMID:
23277001
12.

The development of therapeutic monoclonal antibodies: overview of the nonclinical safety assessment.

Lansita JA, Mounho-Zamora B.

Curr Pain Headache Rep. 2015;19(2):2. doi: 10.1007/s11916-014-0472-x. Review.

PMID:
25681157
13.

Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective.

Coleman D, Smith G, Lawrence R, McManus D, Diaram S, Edwards J.

Bioanalysis. 2017 May;9(10):787-798. doi: 10.4155/bio-2017-0032. Epub 2017 May 19.

PMID:
28524734
14.

Safety biomarkers in preclinical development: translational potential.

Sasseville VG, Mansfield KG, Brees DJ.

Vet Pathol. 2014 Jan;51(1):281-91. doi: 10.1177/0300985813505117. Epub 2013 Oct 3. Review.

PMID:
24091814
15.

Exploiting pluripotent stem cell technology for drug discovery, screening, safety, and toxicology assessments.

McGivern JV, Ebert AD.

Adv Drug Deliv Rev. 2014 Apr;69-70:170-8. doi: 10.1016/j.addr.2013.11.012. Epub 2013 Dec 2. Review.

PMID:
24309014
16.

Drug induced shortening of the QT/QTc interval: an emerging safety issue warranting further modelling and evaluation in drug research and development?

Holbrook M, Malik M, Shah RR, Valentin JP.

J Pharmacol Toxicol Methods. 2009 Jan-Feb;59(1):21-8. doi: 10.1016/j.vascn.2008.09.001. Epub 2008 Sep 17.

PMID:
18834945
17.

Toxicology in the drug discovery and development process.

Dorato MA, Buckley LA.

Curr Protoc Pharmacol. 2006 Apr;Chapter 10:Unit10.3. doi: 10.1002/0471141755.ph1003s32.

PMID:
22294168
18.

PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development.

Ivens IA, Achanzar W, Baumann A, Brändli-Baiocco A, Cavagnaro J, Dempster M, Depelchin BO, Rovira AR, Dill-Morton L, Lane JH, Reipert BM, Salcedo T, Schweighardt B, Tsuruda LS, Turecek PL, Sims J.

Toxicol Pathol. 2015 Oct;43(7):959-83. doi: 10.1177/0192623315591171. Epub 2015 Aug 3. Review.

PMID:
26239651
19.

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

Roberts SA, Andrews PA, Blanset D, Flagella KM, Gorovits B, Lynch CM, Martin PL, Kramer-Stickland K, Thibault S, Warner G.

Regul Toxicol Pharmacol. 2013 Dec;67(3):382-91. doi: 10.1016/j.yrtph.2013.08.017. Epub 2013 Sep 5.

PMID:
24012707
20.

Drug discovery through stem cell-based organoid models.

Ranga A, Gjorevski N, Lutolf MP.

Adv Drug Deliv Rev. 2014 Apr;69-70:19-28. doi: 10.1016/j.addr.2014.02.006. Epub 2014 Feb 26. Review.

PMID:
24582599

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