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Modification to improve efficiency of sampling schedules for BA/BE testing of FDC anti-tuberculosis drugs.
Int J Tuberc Lung Dis. 2007 Feb; 11(2):181-8.IJ

Abstract

SETTING

The assessment of rifampicin (RMP) containing fixed-dose combination (FDC) formulations using in vivo bioequivalence testing is widely accepted. It would be advantageous for both the drug regulatory authorities and drug manufacturers, for optimum minimum blood testing time intervals that encompass all anti-tuberculosis active constituents in the FDC to be established.

OBJECTIVE

To determine the optimum blood sampling schedule for testing novel FDC anti-tuberculosis drugs, isoniazid, RMP, pyrazinamide and ethambutol

DESIGN

The results of 12 different single-dose, two-way cross-over designs are presented. The studies determined the bioavailability and bioequivalence of RMP-containing FDCs, and conformed with the requirements of the South African national drug regulatory authority for each of the active constituents.

RESULTS

The pharmacokinetic parameters to determine bioavailability and the Hauschke method to determine bioequivalence revealed that a six-point time protocol, namely 0, 1, 2, 4, 6 and 8 h, provides a good approximation of the area under the curve, and that an 11-point time protocol of 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h provided information comparable to the conventional 15 time-points for FDCs containing up to four drugs.

CONCLUSION

The findings provide concrete economic benefit and convenience for quality assurance testing of existing and novel FDCs.

Authors+Show Affiliations

Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Rondebosch, South Africa. ggabriel@uctgsh1.uct.ac.zaNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17263289

Citation

Gabriels, G A., et al. "Modification to Improve Efficiency of Sampling Schedules for BA/BE Testing of FDC Anti-tuberculosis Drugs." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 11, no. 2, 2007, pp. 181-8.
Gabriels GA, McIlleron H, Smith PJ, et al. Modification to improve efficiency of sampling schedules for BA/BE testing of FDC anti-tuberculosis drugs. Int J Tuberc Lung Dis. 2007;11(2):181-8.
Gabriels, G. A., McIlleron, H., Smith, P. J., Folb, P. I., & Fourie, P. B. (2007). Modification to improve efficiency of sampling schedules for BA/BE testing of FDC anti-tuberculosis drugs. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 11(2), 181-8.
Gabriels GA, et al. Modification to Improve Efficiency of Sampling Schedules for BA/BE Testing of FDC Anti-tuberculosis Drugs. Int J Tuberc Lung Dis. 2007;11(2):181-8. PubMed PMID: 17263289.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Modification to improve efficiency of sampling schedules for BA/BE testing of FDC anti-tuberculosis drugs. AU - Gabriels,G A, AU - McIlleron,H, AU - Smith,P J, AU - Folb,P I, AU - Fourie,P B, PY - 2007/2/1/pubmed PY - 2007/3/7/medline PY - 2007/2/1/entrez SP - 181 EP - 8 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 - 11 IS - 2 N2 - SETTING: The assessment of rifampicin (RMP) containing fixed-dose combination (FDC) formulations using in vivo bioequivalence testing is widely accepted. It would be advantageous for both the drug regulatory authorities and drug manufacturers, for optimum minimum blood testing time intervals that encompass all anti-tuberculosis active constituents in the FDC to be established. OBJECTIVE: To determine the optimum blood sampling schedule for testing novel FDC anti-tuberculosis drugs, isoniazid, RMP, pyrazinamide and ethambutol DESIGN: The results of 12 different single-dose, two-way cross-over designs are presented. The studies determined the bioavailability and bioequivalence of RMP-containing FDCs, and conformed with the requirements of the South African national drug regulatory authority for each of the active constituents. RESULTS: The pharmacokinetic parameters to determine bioavailability and the Hauschke method to determine bioequivalence revealed that a six-point time protocol, namely 0, 1, 2, 4, 6 and 8 h, provides a good approximation of the area under the curve, and that an 11-point time protocol of 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h provided information comparable to the conventional 15 time-points for FDCs containing up to four drugs. CONCLUSION: The findings provide concrete economic benefit and convenience for quality assurance testing of existing and novel FDCs. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/17263289/Modification_to_improve_efficiency_of_sampling_schedules_for_BA/BE_testing_of_FDC_anti_tuberculosis_drugs_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=11&issue=2&spage=181&aulast=Gabriels DB - PRIME DP - Unbound Medicine ER -