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Approximately 68 brands of azithromycin capsule formulations are available in Pakistan; however, published data on their bioequivalence in the Pakistani population are not available.
Several generic formulations of tramadol are available in Brazil; however, published information regarding their bioequivalence in the Brazilian population is not available.
Compared with Zentrip®, MH OTF successfully overcome the weakness of mechanical strength, possessed faster dissolution profile and showed bioequivalence in pharmacokinetics, deserving to a further development.
Both the US Food and Drug Administration FDA and EMAMA have provided definitions of bioequivalence in comparing two products containing the same active compounds, and have also provided guidance regarding the parameters that should be employed in measuring bioequivalence.
The ROI values of the bioequivalence-indicating parameters were 61.90%, 84.6%, and 76.0% for Cmax, AUC0→12, and AUC0→∞, respectively, which are indicative for bioequivalence in all the cases.
Testing bioequivalence in the way presented above has become the general, standard procedure.
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In the study of bioequivalence conducted in Brazil, healthy volunteers received two ethinylestradiol 0.035 mg tablet formulations using an open, randomized, two-period crossover design with a 2-week washout interval.
In general, participating physicians showed a low level of trust in bioequivalence tests conducted in South Korea between generic and branded drugs.
It, therefore, becomes apparent that the dissolution data derived from the physico-chemically and hydro-dynamically defined conditions is required in order to compare various in vitro dissolution data and to be able to use such results as a surrogate for possible in vivo bioequivalence testing and in vitro- in vivo correlations (IVIVC) [ 1, 2].
It remains unclear if Neoral and generic cyclosporine are bioequivalent based on EMA and Health Canada criteria and if bioequivalence exists in recipients of a non-renal solid organ transplant.
As a direct fallout, our formalism opens a new path toward the bioequivalence evaluation in terms of PK and PD, which associates the in vivo drug concentration and the in vitro drug effect.
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