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An avian reproduction study historical control database: A tool for data interpretation.

Authors :
Valverde-Garcia P
Springer T
Kramer V
Foudoulakis M
Wheeler JR
Source :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2018 Feb; Vol. 92, pp. 295-302. Date of Electronic Publication: 2017 Dec 11.
Publication Year :
2018

Abstract

Avian reproduction studies are a regulatory requirement for pesticides in many regions. The data often require careful interpretation due to the nature of the study design. Here we present the historical control dataset for bobwhite quail and mallard duck reproduction studies performed at the Evans Analytical Group LLC avian toxicology laboratory over the period 1985-2016. The analysis demonstrates the stability of reproductive parameters over time and good agreement to normal control ranges as required by the regulatory test guidelines. The major source of variation is shown to be within study variation. Power analyses confirm the generally good power properties of the test design. Recommendations for the use of historical control data for the interpretation of avian reproduction studies are made. We believe the analysis and evaluation presented here can facilitate the development of practical guidance that can be implemented in regulatory programmes requiring this test.<br /> (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1096-0295
Volume :
92
Database :
MEDLINE
Journal :
Regulatory toxicology and pharmacology : RTP
Publication Type :
Academic Journal
Accession number :
29242156
Full Text :
https://doi.org/10.1016/j.yrtph.2017.12.004