Bioequivalence Study of Two Formulations Containing Bosutinib 500 mg Tablets in Healthy Colombian Volunteers
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To analyze the bioavailability of the Test product (Bosutinib 500 mg, made by Laboratorios Lafrancol S.A., Colombia) by correlating with the Reference product (Bosulif® made by Pfizer), the pharmacokinetic study of the two formulations were done. This study will affirm the bioequivalence between the same. A crossover study was carried out with 36 healthy volunteers where a single 500 mg dose was administered during fasting condition, having 15 days washout period and 12 plasma samples were collected within 0-72 h. The trial was open-label and two period and two sequence randomized earlier. High-resolution liquid chromatography method was used for analysis and mass spectrometry detector tandem HPLC MS/MS was done to identify and quantify the plasma Bosutinib. The parameters considered during the pharmacokinetic study are as follows: The statistical analysis of these parameters determines the confidence intervals to 90% as appealed by the FDA and EMA international and national regulatory agencies (INVIMA). As per the European and FDA guidelines for Bioequivalence research, the Confidence Interval is within the granted the Bioequivalence criteria affirmation and correlation of the Lafrancol S.A. product between the Reference product.
J Bioequiv Availab Volume 9(1): 299-301 (2016)
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- Facultad de Medicina