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Plasma pooling methodology as a faster and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs.
Pharmacol Res. 2003 Dec; 48(6):655-63.PR

Abstract

Rifampicin is one of the most important first line drugs used in fixed dose combinations (FDCs) of antitubercular drugs. The chances of reduced bioavailability of rifampicin from FDCs necessitated its evaluation against standard formulations of individual drugs in bioequivalence studies. This study was undertaken to evaluate the importance of plasma pooling methodology as a rapid and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs. Plasma samples of volunteers obtained from bioequivalence studies were pooled according to volunteer and time-wise pooling. Area under the plasma concentration versus time curves (AUCs) of rifampicin was reduced in the pooled plasma samples when compared to the individual samples. However, the ratio of AUCs of FDCs to that of separate formulations was found to be comparable for both the individual samples and pooled samples data. Concentration-time profiles of rifampicin obtained after time-wise pooling were subjected to non-compartmental analysis for determination of pharmacokinetic parameters. Whereas bioequivalence estimates were determined using individual AUC values obtained from volunteer-wise pooling. Results indicated the possibility of using plasma pooling methodology in bioequivalence estimation of rifampicin to simplify and accelerate the registration process.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, Phase-X, Mohali, Punjab 160062, India. panchagnula@yahoo.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

14527833

Citation

Panchagnula, Ramesh, et al. "Plasma Pooling Methodology as a Faster and Cheaper Tool to Evaluate Bioequivalence of Rifampicin Component of FDCs of Antitubercular Drugs." Pharmacological Research, vol. 48, no. 6, 2003, pp. 655-63.
Panchagnula R, Sharma A, Agrawal S. Plasma pooling methodology as a faster and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs. Pharmacol Res. 2003;48(6):655-63.
Panchagnula, R., Sharma, A., & Agrawal, S. (2003). Plasma pooling methodology as a faster and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs. Pharmacological Research, 48(6), 655-63.
Panchagnula R, Sharma A, Agrawal S. Plasma Pooling Methodology as a Faster and Cheaper Tool to Evaluate Bioequivalence of Rifampicin Component of FDCs of Antitubercular Drugs. Pharmacol Res. 2003;48(6):655-63. PubMed PMID: 14527833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Plasma pooling methodology as a faster and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs. AU - Panchagnula,Ramesh, AU - Sharma,Ajay, AU - Agrawal,Shrutidevi, PY - 2003/10/7/pubmed PY - 2004/8/13/medline PY - 2003/10/7/entrez SP - 655 EP - 63 JF - Pharmacological research JO - Pharmacol Res VL - 48 IS - 6 N2 - Rifampicin is one of the most important first line drugs used in fixed dose combinations (FDCs) of antitubercular drugs. The chances of reduced bioavailability of rifampicin from FDCs necessitated its evaluation against standard formulations of individual drugs in bioequivalence studies. This study was undertaken to evaluate the importance of plasma pooling methodology as a rapid and cheaper tool to evaluate bioequivalence of rifampicin component of FDCs of antitubercular drugs. Plasma samples of volunteers obtained from bioequivalence studies were pooled according to volunteer and time-wise pooling. Area under the plasma concentration versus time curves (AUCs) of rifampicin was reduced in the pooled plasma samples when compared to the individual samples. However, the ratio of AUCs of FDCs to that of separate formulations was found to be comparable for both the individual samples and pooled samples data. Concentration-time profiles of rifampicin obtained after time-wise pooling were subjected to non-compartmental analysis for determination of pharmacokinetic parameters. Whereas bioequivalence estimates were determined using individual AUC values obtained from volunteer-wise pooling. Results indicated the possibility of using plasma pooling methodology in bioequivalence estimation of rifampicin to simplify and accelerate the registration process. SN - 1043-6618 UR - https://www.unboundmedicine.com/medline/citation/14527833/Plasma_pooling_methodology_as_a_faster_and_cheaper_tool_to_evaluate_bioequivalence_of_rifampicin_component_of_FDCs_of_antitubercular_drugs_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1043661803002433 DB - PRIME DP - Unbound Medicine ER -