How is the safety of Cremophor EL assessed in drug formulations?
The safety of Cremophor EL in drug formulations is evaluated through extensive preclinical and clinical testing. This includes assessing the potential for hypersensitivity, cardiovascular effects, and other adverse reactions. Regulatory agencies require comprehensive data on the toxicology, pharmacokinetics, and pharmacodynamics of formulations containing Cremophor EL to ensure patient safety.