Detalhe da pesquisa
1.
Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
Regul Toxicol Pharmacol
; 115: 104697, 2020 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-32590049
2.
Safety Pharmacology Evaluation of Biopharmaceuticals.
Handb Exp Pharmacol
; 229: 385-404, 2015.
Artigo
Inglês
| MEDLINE | ID: mdl-26091648
3.
Evaluation of levocetirizine in beagle dog and cynomolgus monkey telemetry assays: Defining the no QTc effect profile by timepoint and concentration-QTc analysis.
Clin Transl Sci
; 16(3): 436-446, 2023 03.
Artigo
Inglês
| MEDLINE | ID: mdl-36369797
4.
Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As.
J Pharmacol Toxicol Methods
; 123: 107270, 2023.
Artigo
Inglês
| MEDLINE | ID: mdl-37164235
5.
The in vivo QTc core assay: An evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies.
J Pharmacol Toxicol Methods
; 109: 107067, 2021.
Artigo
Inglês
| MEDLINE | ID: mdl-33857614
6.
The Effects of Repeat-Dose Doxorubicin on Cardiovascular Functional Endpoints and Biomarkers in the Telemetry-Equipped Cynomolgus Monkey.
Front Cardiovasc Med
; 8: 587149, 2021.
Artigo
Inglês
| MEDLINE | ID: mdl-33708802
7.
Evaluation of moxifloxacin in canine and non-human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration-QTc analysis.
Clin Transl Sci
; 14(6): 2379-2390, 2021 11.
Artigo
Inglês
| MEDLINE | ID: mdl-34173339
8.
Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
Clin Pharmacol Ther
; 109(2): 310-318, 2021 02.
Artigo
Inglês
| MEDLINE | ID: mdl-32866317
9.
Clinical Implications and Translation of an Off-Target Pharmacology Profiling Hit: Adenosine Uptake Inhibition In Vitro.
Transl Oncol
; 12(10): 1296-1304, 2019 Oct.
Artigo
Inglês
| MEDLINE | ID: mdl-31330495
10.
Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms.
Front Pharmacol
; 10: 884, 2019.
Artigo
Inglês
| MEDLINE | ID: mdl-31447679
11.
Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes.
Front Pharmacol
; 10: 934, 2019.
Artigo
Inglês
| MEDLINE | ID: mdl-31555128
12.
The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs.
J Pharmacol Toxicol Methods
; 92: 43-51, 2018.
Artigo
Inglês
| MEDLINE | ID: mdl-29505899
13.
ILSI-HESI cardiovascular safety subcommittee dataset: an analysis of the statistical properties of QT interval and rate-corrected QT interval (QTc).
J Pharmacol Toxicol Methods
; 56(2): 95-102, 2007.
Artigo
Inglês
| MEDLINE | ID: mdl-17588780
14.
An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs.
J Pharmacol Toxicol Methods
; 85: 1-21, 2017.
Artigo
Inglês
| MEDLINE | ID: mdl-28065821
15.
Corrigendum to "The in vivo QTc core assay: An evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies" [Journal of Pharmacological and Toxicological Methods 109 (2021) 107067].
J Pharmacol Toxicol Methods
; 112: 107104, 2021.
Artigo
Inglês
| MEDLINE | ID: mdl-34334315
16.
QT prolongation and proarrhythmia by moxifloxacin: concordance of preclinical models in relation to clinical outcome.
Br J Pharmacol
; 146(6): 792-9, 2005 Nov.
Artigo
Inglês
| MEDLINE | ID: mdl-16158069
17.
The evaluation of drug-induced changes in cardiac inotropy in dogs: Results from a HESI-sponsored consortium.
J Pharmacol Toxicol Methods
; 75: 70-90, 2015.
Artigo
Inglês
| MEDLINE | ID: mdl-25843226
18.
Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals.
Expert Opin Drug Saf
; 12(1): 91-102, 2013 Jan.
Artigo
Inglês
| MEDLINE | ID: mdl-23170873
19.
Inhibition of casein kinase I epsilon/delta produces phase shifts in the circadian rhythms of Cynomolgus monkeys.
Psychopharmacology (Berl)
; 204(4): 735-42, 2009 Jul.
Artigo
Inglês
| MEDLINE | ID: mdl-19277609