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pro vyhledávání: '"Jim Saul"'
Discussion on statistical analysis of carcinogenicity studies with an early terminated treated group
Autor:
Jim Saul, Kelly Ashcroft-Hawley
Publikováno v:
Pharmaceutical Statistics. 19:326-334
High rates of mortality on long term carcinogenicity studies can often result in challenges when it comes to the statistical analysis of tumor incidence. The current regulatory advice often results in treated groups being terminated earlier than the
Autor:
Sarah Phillips, Julie Clements, Jim Saul, Robert Smith, Darren Kidd, Teresa Chirom, James Whitwell, Nicky Mason
Publikováno v:
Mutagenesis. 36:37-49
Implementation of the seventh amendment to the EU Cosmetics Directive has driven much research into suitable in vitro alternative assays to support satisfactory risk assessments. One such assay is the reconstructed skin micronucleus (RSMN) assay. Fir
Autor:
U. Hemmann, Jim Saul, James Whitwell, B.M. van der Leede, Stephen D. Dertinger, P. Escobar, Andreas Zeller, Julia Kenny, Robert Smith, David P. Lovell, R. Fiedler, Laura Custer, Mick D. Fellows
A database of micronuclei counts for historical negative control data from rat in vivo micronuclei tests performed in 10 different laboratories was established. Data were available from over 4000 negative control rats from 10 laboratories. The mean f
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https://explore.openaire.eu/search/publication?articleId=doi_dedup___::26ce64fec9cd31402b79b499b439c2ac
Autor:
Alain Dieterlen, F. Finot, Jim Saul, L. Morat, N. Prigent, J. Clements, I. Mouche, S. Négrault, N. Zaguia, M. El May, Laure Sabatier, D. Souverville, Radhia M'kacher, P. Lafouge, F. Paillard, Leonhard Heidingsfelder, William M. Hempel, Bruno Colicchio, Corina Cuceu, Olivier Cariou, Eric Jeandidier, M. Al Jawhari, A. Kaddour, A. Essahli
Publikováno v:
Journal of Applied Toxicology. 37:758-771
The ability of parabens to promote the appearance of multiple cancer hallmarks in breast epithelium cells provides grounds for regulatory review of the implication of the presence of parabens in human breast tissue. It is well documented that telomer
Publikováno v:
Toxicology in Vitro. 27:1312-1319
In vitro genotoxicity assays are often used to compare tobacco smoke particulate matter (PM) from different cigarettes. The quantitative aspect of the comparisons requires appropriate statistical methods and replication levels, to support the interpr
Publikováno v:
Pharmaceutical Statistics. 10:477-484
The Statisticians in the Pharmaceutical Industry Toxicology Special Interest Group has collated and compared statistical analysis methods for a number of toxicology study types including general toxicology, genetic toxicology, safety pharmacology and
Publikováno v:
Pharmaceutical Statistics. 10:236-249
In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are
Autor:
Philip Jarvis, Richardus Vonk, Helena Geys, Jim Saul, Mike Aylott, Jonathan Bright, Simon T. Bate
Publikováno v:
Pharmaceutical statistics. 10(6)
In 2010, the Statisticians in the Pharmaceutical Industry (PSI) Toxicology Special Interest Group met to discuss the design and analysis of the Comet assay. The Comet assay is one potential component of the package of safety studies required by regul