Elham, Ghasemian; Sima, Sadrai; Javad, Shokri; Shahram, Sayadi published the artcile< Analytical method validation, pharmacokinetics and bioequivalence study of dimethyl fumarate in healthy Iranian volunteers>, SDS of cas: 112-63-0, the main research area is validation pharmacokinetics bioequivalence dimethyl fumarate.
Pharmacokinetic evaluation of Di-Me Fumarate (DMF) in the Iranian population wasn’t studied. So, the aim of this research is the validation of the anal. method and evaluation of the pharmacokinetic properties and bioequivalence of the generic form of this drug vs. the reference product. 2 Single-dose, test, and reference DMF products were orally administered to 24 healthy volunteers. The washout period was 28 d between the treatments. Monomethyl fumarate as the metabolite of DMF was analyzed by liquid chromatog.-tandem mass spectrometry (LC-MS/MS) and the method was validated. Also, the pharmacokinetic parameters were calculated for bioequivalence evaluation. The anal. method was validated and linear over the range of 31.25-4000 ng/mL (R2 = 0.997). In addition, the method was precise and accurate in the low, medium, and high concentrations The results indicated that the 2 products had similar pharmacokinetics. Further, the 90% CI of the mean ratios of the test vs. the reference products of the log-transformed area under the concentration-time curve over 10 h (0.99 to 1.02) and peak concentration (0.98 to 1.03) were within the acceptable range of 0.8 to 1.25 and the generic product of DMF could be similar to that of the reference product. The applied anal. method is selective, accurate, precise, and repeatable for the anal. of monomethyl fumarate (MMF) in plasma. Also, the bioequivalence study showed no significant difference between the pharmacokinetic parameters of these 2 products. So, the DMF test product can be claimed to be bioequivalent with the reference product.
International Journal of Pharmacy and Pharmaceutical Sciences published new progress about Drug bioequivalence. 112-63-0 belongs to class esters-buliding-blocks, and the molecular formula is C19H34O2, SDS of cas: 112-63-0.
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