Plasma pooling: Utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations

International Journal of Tuberculosis and Lung Disease

Volumn 9, Issue 6, 2005, Pages 697-699

  Ashokraj, Y ^a   Singh, I ^a   Kaur, K J ^a   Kohli, G ^a   Bhade, S R ^a   Varma, M V S ^a   Kaul, C L ^a   Panchagnula, Ramesh ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Bioequivalence; FDC; Plasma pooling; Rifampicin

Indexed keywords

ETHAMBUTOL; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN; TUBERCULOSTATIC AGENT;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DRUG BLOOD LEVEL; DRUG DOSAGE FORM; DRUG FORMULATION; HUMAN; PLASMA POOLING; PRIORITY JOURNAL;

ANTIBIOTICS, ANTITUBERCULAR; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; DRUG COMBINATIONS; HUMANS; RIFAMPIN; THERAPEUTIC EQUIVALENCY;

EID: 20444488107     PISSN: 10273719     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. Fourie B, Pillai G, Mclleron H, et al. Establishing the bioequivalence of rifampicin in fixed dose formulations containing isoniazid with or without pyrazinamide and/or ethambutol compared to single drug reference preparations administered in loose combination (Model Protocol). WHO/CDS/TB/99.274,1999. Geneva, Switzerland: World Health Organization, 1999.
2. Agrawal S, Kaur K J, Singh I, Bhade S R, Kaul C L, Panchagnula R. Determination of rifampicin bioequivalence in a three-drug FDC by WHO and Indian protocols: effect of sampling schedule and size. Int J Tuberc Lung Dis 2005; 9: 75-80.
3. 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: 655-663.
4. Ashokraj Y, Singh I, Kaur K J, et al. Establishment of reference formulation for bioequivalence assessment of rifampicin containing fixed dose combinations: an essential step towards improvement in the treatment of tuberculosis. Int J Tuberc Lung Dis 2005; (in press).
5. Panchagnula R, Sood A, Sharda N, Kaur K, Kaul C L. Determination of rifampicin and its main metabolite in presence of pyrazinamide and isoniazid in plasma and urine samples by HPLC method. J Pharm Biomed Analysis 1999; 18: 1013-1020.