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Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol.
Int J Tuberc Lung Dis. 2000 Dec; 4(12):1169-72.IJ

Abstract

For an accurate assessment of rifampicin bioequivalence from fixed-dose combinations (FDCs), and to reduce the time and cost constraints associated with bioequivalence studies, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have developed a simplified screening protocol. This study was undertaken with the objective of testing the applicability of this protocol for all types of FDCs. Data were obtained for volunteers common to three studies, and pharmacokinetic parameters were evaluated by different statistical tests. From the results, it has been demonstrated that the simplified screening protocol is suitable for evaluating the bioequivalence of rifampicin in all the types of FDCs available on the market.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article

Language

eng

PubMed ID

11144460

Citation

Panchagnula, R, et al. "Evaluation of Rifampicin Bioequivalence in Fixed-dose Combinations Using the WHO/IUATLD Recommended Protocol." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 4, no. 12, 2000, pp. 1169-72.
Panchagnula R, Agrawal S, Kaur KJ, et al. Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol. Int J Tuberc Lung Dis. 2000;4(12):1169-72.
Panchagnula, R., Agrawal, S., Kaur, K. J., Singh, I., & Kaul, C. L. (2000). Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 4(12), 1169-72.
Panchagnula R, et al. Evaluation of Rifampicin Bioequivalence in Fixed-dose Combinations Using the WHO/IUATLD Recommended Protocol. Int J Tuberc Lung Dis. 2000;4(12):1169-72. PubMed PMID: 11144460.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of rifampicin bioequivalence in fixed-dose combinations using the WHO/IUATLD recommended protocol. AU - Panchagnula,R, AU - Agrawal,S, AU - Kaur,K J, AU - Singh,I, AU - Kaul,C L, PY - 2001/1/6/pubmed PY - 2001/3/7/medline PY - 2001/1/6/entrez SP - 1169 EP - 72 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 - 4 IS - 12 N2 - For an accurate assessment of rifampicin bioequivalence from fixed-dose combinations (FDCs), and to reduce the time and cost constraints associated with bioequivalence studies, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have developed a simplified screening protocol. This study was undertaken with the objective of testing the applicability of this protocol for all types of FDCs. Data were obtained for volunteers common to three studies, and pharmacokinetic parameters were evaluated by different statistical tests. From the results, it has been demonstrated that the simplified screening protocol is suitable for evaluating the bioequivalence of rifampicin in all the types of FDCs available on the market. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/11144460/Evaluation_of_rifampicin_bioequivalence_in_fixed_dose_combinations_using_the_WHO/IUATLD_recommended_protocol_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=4&issue=12&spage=1169&aulast=Panchagnula DB - PRIME DP - Unbound Medicine ER -