Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations. |
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Authors: | Y Ashokraj I Singh K J Kaur G Kohli S R Bhade M V S Varma C L Kaul R Panchagnula |
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Institution: | Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, India. |
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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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