Evaluation of the bioequivalence of two faropenem formulations in healthy indian subjects

Arzneimittel-Forschung/Drug Research

Volumn 58, Issue 12, 2008, Pages 681-685

  Bhaumik, Uttam ^a   Ghosh, Animesh ^a   Chakrabarty, Uday S ^a   Mandal, Uttam ^a   Bose, Anirbandeep ^a   Das, Ayan ^a   Ray, Kamala Kanta ^a   Pal, Tapan K ^a  

^a JADAVPUR UNIVERSITY   (India)

Author keywords

Antimicrobials, lactam; CAS 106560 14 9; Faropenem, bioequivalence, pharmacokinetics

Indexed keywords

FROPENEM; HYDROCHLOROTHIAZIDE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE TIME EFFECT RELATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; INDIA; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; TIME TO MAXIMUM PLASMA CONCENTRATION; ULTRAVIOLET SPECTROSCOPY;

EID: 58149236839     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296571     Document Type: Article

References (15)

1. Wise R, Ballard RC. Review of the in-vitro evaluation of FCE 22101. J Antimicrob Chemother. 1989;23:7-16.
2. Woodcock JM, Andrews JM, Brenwald NP, Ashby JP, Wise R. The in-vitro activity of faropenem, a novel oral penem. J Antimicrob Chemother. 1987;39:35-43.
3. Nirogi RV, Kandikere VN, Shrivastava W, Mudigonda K. Quantification of faropenem in human plasma by high-performance liquid chromatography. Arzneimittel-Forschung (Drug Research). 2005;55(12):762-766.
4. Shouhong G, Wansheng C, Xia T, Haijun M, Shaoin Y, Rong W. Determination of faropenem in human plasma and urine by liquid chromatography-tandem mass spectrometry. Biomed Chrom. 2008;22:5-12.
5. Hauschke D, Steinijans V Diletti E. A distribution free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990;30:37-43.
6. Schulz HU, Steinijans VW. Striving for standards in bioequivalence assessment: a review. Int J Clin Pharmacol Ther Toxicol. 1992;30:51-56.
7. Farolfi M, Power JD, Rescigno A. On the determination of bioequivalence. Pharmacol Res. 1999;39:1-4.
8. Mandal U, Musmade P, Chakraborty M, Rajan DS, Chakravarti M, Pal TK, et al. Bioequivalence Study of Sildenafil citrate tablets in healthy human volunteers. Boll Chim Farm. 2004a;143:345-349.
9. Mandal U, Ganesan M, Pal TK, Jayakumar M, Chattaraj TK, Ray K, et al. Bioequivalence Study of Rabeprazole Sodium on Healthy Human Volunteers. J Indian Med Assoc. 2004b;102(1):26-30.
10. Gowda KV, Rajan DS, Mandal U, Selvan PS, Solomon WDS, Bose A, et al. Evaluation of bioequivalence of two formulations containing 100 miligrams of aceclofenac. Drug Dev Ind Pharm. 2006;32:1219-1225.
11. U. S. Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for orally Administered Drug Products- General Considerations. Rockville, MD: Center for Drug Evaluation and Research. 2000.
12. European Agency for the Evaluation of Medicinal Products. Note for guidance on the investigation of bioavailability and bioequivalence CPMP/EWP/QWP/1401/98. 2002.
13. Committee for Proprietary Medicinal Products (CPMP). Note for Guidance: Investigation of Bioavailability and Bioequivalence. London: Working Party on the Efficacy of the Medicinal Products. 1991.
14. Nation RL, Sansom LN. Bioequivalence requirements for generic products. Pharmacol Ther. 1994;62:41-55.
15. Shah VP, Midha KK, Sighe S. Analytical method validation: bioavailability, bioequivalence and Pharmacokinetic studies. Eur J Drug Metab Pharmacokinet. 1992;16: 249-255.