Detalles de la búsqueda
1.
Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection.
Regul Toxicol Pharmacol
; 107: 104413, 2019 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-31229519
2.
Analysis of exposure margins in developmental toxicity studies for detection of human teratogens.
Regul Toxicol Pharmacol
; 105: 62-68, 2019 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-30981719
3.
Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in guinea pigs and rhesus monkeys.
Hepatology
; 64(5): 1430-1441, 2016 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-27474787
4.
Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective.
Regul Toxicol Pharmacol
; 87 Suppl 3: S1-S15, 2017 Jul 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-28483710
5.
Interaction between amiodarone and hepatitis-C virus nucleotide inhibitors in human induced pluripotent stem cell-derived cardiomyocytes and HEK-293 Cav1.2 over-expressing cells.
Toxicol Appl Pharmacol
; 308: 66-76, 2016 10 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27520758
6.
An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors.
Birth Defects Res B Dev Reprod Toxicol
; 107(2): 108-19, 2016 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-27062127
7.
Role of chronic toxicology studies in revealing new toxicities.
Regul Toxicol Pharmacol
; 82: 94-98, 2016 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-27769827
8.
Regulatory Forum Commentary* Counterpoint: Dose Selection for Tg.rasH2 Mouse Carcinogenicity Studies.
Toxicol Pathol
; 43(5): 621-7, 2015 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-26047967
9.
Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.
Regul Toxicol Pharmacol
; 70(1): 413-29, 2014 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25078890
10.
Phenazin-5-ium hydrogen sulfate monohydrate.
Acta Crystallogr Sect E Struct Rep Online
; 69(Pt 4): o471, 2013 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-23634029
11.
Importance of halogen···halogen contacts for the structural and magnetic properties of CuX2(pyrazine-N,N'-dioxide)(H2O)2 (X = Cl and Br).
Inorg Chem
; 51(4): 2121-9, 2012 Feb 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-22296451
12.
An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.
Toxicol Pathol
; 39(4): 716-44, 2011 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-21666103
13.
A Brief History of Use of Animals in Biomedical Research and Perspective on Non-Animal Alternatives.
ILAR J
; 62(1-2): 7-16, 2021 12 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-34181728
14.
Fit for Purpose Assessment: A New Direction for IACUCs.
ILAR J
; 62(3): 314-331, 2021 12 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-35512294
15.
An industry perspective on the utility of short-term carcinogenicity testing in transgenic mice in pharmaceutical development.
Toxicol Pathol
; 38(1): 51-61, 2010 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-19893055
16.
Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s.
Chem Res Toxicol
; 22(2): 257-62, 2009 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-19170595
17.
Applications of toxicogenomics to nonclinical drug development: regulatory science considerations.
Methods Mol Biol
; 460: 239-61, 2008.
Artículo
en Inglés
| MEDLINE | ID: mdl-18449491
18.
An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials.
Clin Pharmacol Ther
; 103(4): 566-569, 2018 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-29285748
19.
Cardiac drug-drug interaction between HCV-NS5B pronucleotide inhibitors and amiodarone is determined by their specific diastereochemistry.
Sci Rep
; 7: 44820, 2017 03 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-28327633
20.
Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.
ILAR J
; 57(2): 101-108, 2016 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-28053064