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

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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.

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Valverde-Garcia, P., Springer, T., Kramer, V., Foudoulakis, M., & Wheeler, J. R. (2018). An avian reproduction study historical control database: A tool for data interpretation. Regulatory Toxicology and Pharmacology, 92, 295–302.

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