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Alternatives for skin sensitisation: Hazard identification and potency categorisation: Report from an EPAA/CEFIC LRI/Cosmetics Europe cross sector workshop, ECHA Helsinki, April 23rd and 24th 2015.

https://arctichealth.org/en/permalink/ahliterature275417
Source
Regul Toxicol Pharmacol. 2015 Nov;73(2):660-6
Publication Type
Conference/Meeting Material
Date
Nov-2015
Author
David Basketter
Takao Ashikaga
Silvia Casati
Bruno Hubesch
Joanna Jaworska
Joop de Knecht
Robert Landsiedel
Irene Manou
Annette Mehling
Dirk Petersohn
Emiel Rorije
Laura H Rossi
Winfried Steiling
Silvia Teissier
Andrew Worth
Source
Regul Toxicol Pharmacol. 2015 Nov;73(2):660-6
Date
Nov-2015
Language
English
Publication Type
Conference/Meeting Material
Keywords
Animal Testing Alternatives - methods - trends
Animals
Cosmetics - administration & dosage - pharmacokinetics - toxicity
Dermatitis, Allergic Contact - metabolism - pathology
Education - methods - trends
Europe
Finland
Humans
Research Report - trends
Risk Assessment - methods - trends
Skin - drug effects - metabolism - pathology
Abstract
In the two years since the last workshop report, the environment surrounding the prediction of skin sensitisation hazards has experienced major change. Validated non-animal tests are now OECD Test Guidelines. Accordingly, the recent cross sector workshop focused on how to use in vitro data for regulatory decision-making. After a review of general approaches and six case studies, there was broad consensus that a simple, transparent stepwise process involving non-animal methods was an opportunity waiting to be seized. There was also strong feeling the approach should not be so rigidly defined that assay variations/additional tests are locked out. Neither should it preclude more complex integrated approaches being used for other purposes, e.g. potency estimation. All agreed the ultimate goal is a high level of protection of human health. Thus, experience in the population will be the final arbiter of whether toxicological predictions are fit for purpose. Central to this is the reflection that none of the existing animal assays is perfect; the non-animal methods should not be expected to be so either, but by integrated use of methods and all other relevant information, including clinical feedback, we have the opportunity to continue to improve toxicology whilst avoiding animal use.
PubMed ID
26456663 View in PubMed
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Cohorts and consortia conference: a summary report (Banff, Canada, June 17-19, 2009).

https://arctichealth.org/en/permalink/ahliterature138153
Source
Cancer Causes Control. 2011 Mar;22(3):463-8
Publication Type
Article
Conference/Meeting Material
Date
Mar-2011
Author
Paolo Boffetta
Graham A Colditz
John D Potter
Laurence Kolonel
Paula J Robson
Reza Malekzadeh
Daniela Seminara
Ellen L Goode
Keun-Young Yoo
Paul Demers
Richard Gallagher
Ross Prentice
Yutaka Yasui
Kieran O'Doherty
Gloria M Petersen
Cornelia M Ulrich
Ilona Csizmadi
Ernest K Amankwah
Nigel T Brockton
Karen Kopciuk
S Elizabeth McGregor
Linda E Kelemen
Author Affiliation
The Tisch Cancer Institute, Mount Sinai School of Medicine, One Gustave L. Levy Place, New York, NY 10029, USA. paolo.boffetta@i-pri.org
Source
Cancer Causes Control. 2011 Mar;22(3):463-8
Date
Mar-2011
Language
English
Publication Type
Article
Conference/Meeting Material
Keywords
Canada
Case-Control Studies
Clinical Trials as Topic - methods
Cohort Studies
Environmental Exposure - analysis
Humans
Research Report
Risk Assessment - methods
Sample Size
Abstract
Epidemiologic studies have adapted to the genomics era by forming large international consortia to overcome issues of large data volume and small sample size. Whereas both cohort and well-conducted case-control studies can inform disease risk from genetic susceptibility, cohort studies offer the additional advantages of assessing lifestyle and environmental exposure-disease time sequences often over a life course. Consortium involvement poses several logistical and ethical issues to investigators, some of which are unique to cohort studies, including the challenge to harmonize prospectively collected lifestyle and environmental exposures validly across individual studies. An open forum to discuss the opportunities and challenges of large-scale cohorts and their consortia was held in June 2009 in Banff, Canada, and is summarized in this report.
PubMed ID
21203821 View in PubMed
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