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Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations.
Int J Tuberc Lung Dis. 2005 Jun; 9(6):697-9.IJ

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.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15971401

Citation

Ashokraj, Y, et al. "Plasma Pooling: Utility in Expediting Bioequivalence Assessment of Rifampicin-containing Fixed-dose Combinations." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 9, no. 6, 2005, pp. 697-9.
Ashokraj Y, Singh I, Kaur KJ, et al. Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations. Int J Tuberc Lung Dis. 2005;9(6):697-9.
Ashokraj, Y., Singh, I., Kaur, K. J., Kohli, G., Bhade, S. R., Varma, M. V., Kaul, C. L., & Panchagnula, R. (2005). Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 9(6), 697-9.
Ashokraj Y, et al. Plasma Pooling: Utility in Expediting Bioequivalence Assessment of Rifampicin-containing Fixed-dose Combinations. Int J Tuberc Lung Dis. 2005;9(6):697-9. PubMed PMID: 15971401.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations. AU - Ashokraj,Y, AU - Singh,I, AU - Kaur,K J, AU - Kohli,G, AU - Bhade,S R, AU - Varma,M V S, AU - Kaul,C L, AU - Panchagnula,R, PY - 2005/6/24/pubmed PY - 2005/9/24/medline PY - 2005/6/24/entrez SP - 697 EP - 9 JF - The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease JO - Int. J. Tuberc. Lung Dis. VL - 9 IS - 6 N2 - 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. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/15971401/Plasma_pooling:_utility_in_expediting_bioequivalence_assessment_of_rifampicin_containing_fixed_dose_combinations_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=9&issue=6&spage=697&aulast=Ashokraj DB - PRIME DP - Unbound Medicine ER -