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Explain Lipid Formulations
Three lipid formulations of amphotericin B are marketed in the US: amphotericin B lipid complex (ABLC, Abelcet), liposomal amphotericin B (L-AmB, AmBisome), and amphotericin B colloidal dispersion (ABCD, Amphotec). In clinical trials, these formulations have been at least as effective as amphotericin B deoxycholate.
Compared to conventional amphotericin B, acute infusion-related reactions are worse with Amphotec, less with Abelcet, and least with AmBisome. Nephrotoxicity is less common with lipid-based products and, when it occurs, less severe than with amphotericin B deoxycholate. Liver toxicity, which is generally not associated with amphotericin B deoxycholate, has been reported with the lipid formulations
Why it was necessary to develop regulations on the preparation and sale?
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