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  • Title: Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations.
    Author: Ashokraj Y, Singh I, Kaur KJ, Kohli G, Bhade SR, Varma MV, Kaul CL, Panchagnula R.
    Journal: Int J Tuberc Lung Dis; 2005 Jun; 9(6):697-9. PubMed ID: 15971401.
    Abstract:
    To improve the rapidity of the registration process of rifampicin (RMP) containing fixed-dose combination (FDC) formulations, a plasma pooling methodology was used to increase the throughput of bioanalysis of plasma samples from bioequivalence trials of FDCs. Plasma samples of a biostudy were analysed for RMP using traditional analysis methods as well as a plasma pooling method (volunteer and time pooling). Both methods produced similar results, with less than 15% variability in both volunteer and time pooling. The plasma pooling method for bioanalysis was validated. Further studies are required to identify and reduce the percentage variability.
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