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Plasma pooling to expedite bioequivalence estimation of rifampicin in fixed dose combinations.
Methods Find Exp Clin Pharmacol. 2006 Apr; 28(3):161-7.MF

Abstract

Rifampicin has been found to be one of the most important antitubercular drugs; however, variable bioavailability of rifampicin in some fixed dose combinations (FDCs) as well as separate formulations has been reported in the literature. This resulted in proper evaluation of FDCs with standard protocol for bioequivalence trials. Earlier, plasma pooling as a rapid method for bioequivalence assessment of rifampicin in FDCs was proposed from our laboratory. Results obtained after pooled plasma sample analysis were compared with those from the individual plasma sample analysis. Case studies from our laboratories further validate and support the use of plasma pooling method as a faster and cost effective tool for bioequivalence assessment of rifampicin in FDCs, which will be useful in order to speed up the registration and approval of good quality FDCs.

Authors+Show Affiliations

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar (Mohali), Punjab, India. panchagnula@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

16810342

Citation

Panchagnula, R, et al. "Plasma Pooling to Expedite Bioequivalence Estimation of Rifampicin in Fixed Dose Combinations." Methods and Findings in Experimental and Clinical Pharmacology, vol. 28, no. 3, 2006, pp. 161-7.
Panchagnula R, Parmar J, Kaur JK, et al. Plasma pooling to expedite bioequivalence estimation of rifampicin in fixed dose combinations. Methods Find Exp Clin Pharmacol. 2006;28(3):161-7.
Panchagnula, R., Parmar, J., Kaur, J. K., Singh, I., & Bhade, S. R. (2006). Plasma pooling to expedite bioequivalence estimation of rifampicin in fixed dose combinations. Methods and Findings in Experimental and Clinical Pharmacology, 28(3), 161-7.
Panchagnula R, et al. Plasma Pooling to Expedite Bioequivalence Estimation of Rifampicin in Fixed Dose Combinations. Methods Find Exp Clin Pharmacol. 2006;28(3):161-7. PubMed PMID: 16810342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Plasma pooling to expedite bioequivalence estimation of rifampicin in fixed dose combinations. AU - Panchagnula,R, AU - Parmar,J, AU - Kaur,J K, AU - Singh,I, AU - Bhade,S R, PY - 2006/7/1/pubmed PY - 2006/9/12/medline PY - 2006/7/1/entrez SP - 161 EP - 7 JF - Methods and findings in experimental and clinical pharmacology JO - Methods Find Exp Clin Pharmacol VL - 28 IS - 3 N2 - Rifampicin has been found to be one of the most important antitubercular drugs; however, variable bioavailability of rifampicin in some fixed dose combinations (FDCs) as well as separate formulations has been reported in the literature. This resulted in proper evaluation of FDCs with standard protocol for bioequivalence trials. Earlier, plasma pooling as a rapid method for bioequivalence assessment of rifampicin in FDCs was proposed from our laboratory. Results obtained after pooled plasma sample analysis were compared with those from the individual plasma sample analysis. Case studies from our laboratories further validate and support the use of plasma pooling method as a faster and cost effective tool for bioequivalence assessment of rifampicin in FDCs, which will be useful in order to speed up the registration and approval of good quality FDCs. SN - 0379-0355 UR - https://www.unboundmedicine.com/medline/citation/16810342/Plasma_pooling_to_expedite_bioequivalence_estimation_of_rifampicin_in_fixed_dose_combinations_ L2 - http://journals.prous.com/journals/servlet/xmlxsl/pk_journals.xml_summaryn_pr?p_JournalId=6&p_RefId=985228 DB - PRIME DP - Unbound Medicine ER -