PubMed · 7122605
Formulae for maximum valid dilution.
Abstract
The preparation of test specimens using the MVD calculation represents a reasonable approach to equating the sensitivity of the in vitro and in vivo tests for endotoxin. Labeling of LAL reagents and control standard endotoxins are a point of confusion for the parenterals industry. Government and reagent suppliers must work together expeditiously to provide test materials that are explicitly labeled as to reactivity in EU/ml and ng/ml. The relatively greater reactivity of LAL reagent to environmental endotoxin than the rabbit bioassay provides a greater margin of safety for the in vitro approach than previously anticipated, and suggests that rabbit retest of LAL failures may be appropriate for specific products.
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J F Cooper. 1982. Formulae for maximum valid dilution.. https://pubmed.ncbi.nlm.nih.gov/7122605/
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