Detalhe da pesquisa
1.
Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations.
Int J Toxicol
; : 10915818241255885, 2024 May 31.
Artigo
em Inglês
| MEDLINE | ID: mdl-38822557
2.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Regul Toxicol Pharmacol
; 138: 105329, 2023 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-36592682
3.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Regul Toxicol Pharmacol
; 138: 105339, 2023 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-36649820
4.
Exploring the Definition of "Similar Toxicities": Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species.
Int J Toxicol
; 41(3): 171-181, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-35435047
5.
Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice.
Regul Toxicol Pharmacol
; 126: 105029, 2021 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-34455009
6.
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Regul Toxicol Pharmacol
; 113: 104624, 2020 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-32126256
7.
Reflections on the progress towards non-animal methods for acute toxicity testing of chemicals.
Regul Toxicol Pharmacol
; 102: 30-33, 2019 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-30578838
8.
Integration of Consortia Recommendations for Justification of Animal Use Within Current and Future Drug Development Paradigms.
Int J Toxicol
; 38(4): 319-325, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31220983
9.
Incorporation of capillary microsampling into whole body plethysmography and modified Irwin safety pharmacology studies in rats.
Regul Toxicol Pharmacol
; 73(1): 19-26, 2015 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-26111604
10.
Refinement of the charcoal meal study by reduction of the fasting period.
Altern Lab Anim
; 40(2): 99-107, 2012 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-22762194
11.
Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents.
J Pharmacol Toxicol Methods
; 108: 106959, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33684597
12.
Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data.
Animals (Basel)
; 11(11)2021 Oct 26.
Artigo
em Inglês
| MEDLINE | ID: mdl-34827789
13.
Justification for species selection for pharmaceutical toxicity studies.
Toxicol Res (Camb)
; 9(6): 758-770, 2020 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-33442468
14.
INSPIRE: A European training network to foster research and training in cardiovascular safety pharmacology.
J Pharmacol Toxicol Methods
; 105: 106889, 2020 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-32565326
15.
Social-housing and use of double-decker cages in rat telemetry studies.
J Pharmacol Toxicol Methods
; 96: 87-94, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-30779962
16.
Neurofunctional test batteries in safety pharmacology - Current and emerging considerations for the drug development process.
J Pharmacol Toxicol Methods
; 100: 106602, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31238094
17.
The functional observational battery and modified Irwin test as global neurobehavioral assessments in the rat: Pharmacological validation data and a comparison of methods.
J Pharmacol Toxicol Methods
; 98: 106591, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31146025
18.
The use of human tissue in safety assessment.
J Pharmacol Toxicol Methods
; 93: 29-34, 2018.
Artigo
em Inglês
| MEDLINE | ID: mdl-29753134
19.
Provision of food and water in rodent whole body plethysmography safety pharmacology respiratory studies - Impact on animal welfare and data quality.
J Pharmacol Toxicol Methods
; 88(Pt 1): 79-84, 2017 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-28780373
20.
An Analysis of the Relationship Between Preclinical and Clinical QT Interval-Related Data.
Toxicol Sci
; 159(1): 94-101, 2017 09 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28903488