作者
Thomas H Hutchinson, Sarah Barrett, Mary Buzby, David Constable, Andreas Hartmann, Eileen Hayes, Duane Huggett, Reinhard Laenge, Adam D Lillicrap, Jürg Oliver Straub, Roy S Thompson
发表日期
2003/12
期刊
Environmental Toxicology and Chemistry: An International Journal
卷号
22
期号
12
页码范围
3031-3036
出版商
Wiley Periodicals, Inc.
简介
The pharmaceutical industry gives high priority to animal welfare in the process of drug discovery and safety assessment. In the context of environmental assessments of active pharmaceutical ingredients (APIs), existing U.S. Food and Drug Administration and draft European regulations may require testing of APIs for acute ecotoxicity to algae, daphnids, and fish (base‐set ecotoxicity data used to derive the predicted no‐effect concentration [PNECwater] from the most sensitive of three species). Subject to regulatory approval, it is proposed that testing can be moved from fish median lethal concentration (LC50) testing (typically using ⩾42 fish/API) to acute threshold tests using fewer fish (typically 10 fish/API). To support this strategy, we have collated base‐set ecotoxicity data from regulatory studies of 91 APIs (names coded for commercial reasons). For 73 of the 91 APIs, the algal median effect concentration (EC50 …
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