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FDA List of Bulk Drug Substances for Use in Compounding (503A)

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Leukemic progenitor cells (CFU-AML) show significantly greater sensitivity to heat, experiencing a four-log reduction in viability after 90 minutes at 43C, whereas normal progenitor cells exhibit less than a 50% reduction in viability under the same conditions

Body weight was measured at screening, randomization, and at regular intervals throughout the study (weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 32)