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This overview of the study designs and requirements for complying with 21 CFR 558.15 regulations discusses the many problems, issues, and concerns that have surfaced during the years in which compliance has been attempted. Many details requiring specific attention in these studies are outlined. Through this presentation it becomes apparent that changes and renewed cooperative efforts towards defining requirements are needed from regulating agencies and researchers.
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FAGERBERG et al. (1986) studied this question.
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