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"Bulk Drug Substances Nominated for Use in Compounding Under Section 503A." FDA.gov, April 2026.

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Body size scalers and age factors were the most commonly identified covariates impacting busulfan PK in pediatric patients ( c standardized to 70-kg adult patient were 9.57 L/h and 28.2 L, respectively, which is consistent with previous studies ( To characterize developmental pharmacology, age-dependent physiological maturation functions were applied to describe changes in CL with age

Most studies were conducted in Europe and Asia, and most reported outcomes after 6 months of treatment