LOAEL associated with this NOAEL
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چکیده
Barium and Compounds Substance File (IRIS Ba File). The influential information contained in this file fails to comply with the OMB " Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies ". The information disseminated in EPA's IRIS Barium and Compounds file directly contradicts the information published by EPA in the January 3, 1997 Federal Register and, therefore, cannot represent an EPA consensus position. The IRIS Ba File was revised in 1998 and 1999, yet it contains no mention of the toxicological evaluation conducted by EPA's Office of Pollution, Pesticides, and Toxic Substances reported in 62 FR 366-372 (No. 2, January 3, 1997). There is no explanation of how a radically different interpretation of the same data could be justified. The NOAEL employed to calculate the Oral Reference Dose in the IRIS Ba File is 0.21 mg/kg/day; there is no
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A New Way in Deciding NOAEL Based on the Findings from GLP-Toxicity Test
The FDA guidance focuses on the use of the NOAEL to establish the maximum recommended starting dose. The majority of NOAEL has been described inaccurately or incompletely in final reports for 90-days repeated dose toxicity test based on GLP (good laboratory practice) regulation. This is the most serious one of reasons for why most pharmaceutical companies targeting global markets have disregard...
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