Bioequivalence evaluation of two brands of furosemide 40 mg tablets (Salurin and Lasix) in healthy human volunteers

Biopharmaceutics and Drug Disposition

Volumn 24, Issue 6, 2003, Pages 245-249

  Najib, Naji ^a   Idkaidek, Nasir ^a   Beshtawi, M ^a   Bader, Mohammed ^a   Admour, Isra' ^a   Alam, S Mahmood ^a   Zaman, Q ^b   Dham, Ruwayda ^b  

^a International Pharmaceutical Research Center Amman   (Jordan)

^b Gulf Pharmaceutical Industries   (United Arab Emirates)

Author keywords

Bioequivalence; Furosemide; HPLC; Julphar; Pharmacokinetics

Indexed keywords

FUROSEMIDE; MERSALYL; NAPROXEN;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG TOLERABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; TABLET FORMULATION; VALIDATION PROCESS; VOLUNTEER;

ADMINISTRATION, ORAL; AREA UNDER CURVE; CROSS-OVER STUDIES; DIURETICS; FUROSEMIDE; HALF-LIFE; HUMANS; JORDAN; MALE; TABLETS; THERAPEUTIC EQUIVALENCY; TIME FACTORS;

EID: 0141704300     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.361     Document Type: Article

References (18)

1. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1990; 28: 72-78.
2. Schulz HU, Steinijans VW. Striving for standards in bioequivalence assessment: a review. Int J Clin Pharmacol Ther Toxicol 1992; 30(Suppl. 1): S1-S6.
3. © 2000. medpharm Scientific Publishers, Stuttgart, Germany, Micromedex, Inc, Denver, CO, Vol. 104 expires 6/2002.
4. Jackson EK. Diuretics. In Goodman and Gilman's The Pharmacologic Basis of Therapeutics, 8th edn. Gilman AG, Hardman JG, Limbird Le, Mollinoff PB, Ruddon RW (eds). McGraw-Hill: New York, 1996; 706-709.
5. Boles Ponto LL, Schoenwald RD. Furosemide (frusemide): a pharmacokinetic/pharmacody-namic review (Part I). Clin Pharmacokinet 1990; 18: 381-408.
6. Wells TG. The pharmacology and therapeutics of diuretics in the pediatric patient. Pediatr Clin North Am 1990; 37: 463-504.
7. Greger R, Wangemann P. Loop diuretics. Renal Physiol 1987; 10: 174-183.
8. Product Information: Lasix(R), furosemide. Hoechst-Marion-Roussel Pharmaceuticals, Somerville, NJ, USA, (PI revised 1/96) reviewed 1/2000; Micromedex, Inc, Denver, CO, Vol. 104 expires 6/2002.
9. Gilman AG, Rall TW, Nies AS et al. (eds). Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th edn. Pergamon Press: New York, NY, 1990.
10. AMA Department of Drugs. Drug Evaluations Subscription. American Medical Association: Chicago, IL, 1990.
11. Cutler RE, Forrey AW, Christopher TG et al. Pharmacokinetics of furosemide in normal subjects and functionally anephric patipnts. Clin Pharmacol Ther 1974; 15: 588-596.
12. Vrhovac B, Sarapa N, Bakran I et al. Pharmacokinetic changes in patients with edema. Clin Pharmacokinet 1995; 28: 405-418.
13. Knoben JE, Anderson PO (eds). Handbook of Clinical Drug Data, 6th edn. Drug Intelligence Publications, Inc: Hamilton, IL, 1988.
14. Verbeeck RK, Patwardhan RB, Villeneuve JP et al. Furosemide disposition in cirrhosis. Clin Pharmacol Ther 1982; 31: 719-725.
15. Shah VP, Midha KK, Dighe S et al. Analytical method validation: bioavailability, bioequivalence and pharmacokinetic studies. Eur J Drug Metab Pharmacokin 1992; 16: 249-255.
16. KineticaTM 2000. Version 3.0, Innaphase, User Manual, 1999.
17. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Consideration. US Department of Health and Human Service, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), October 2000.
18. Chow CS, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker: New York, 1992.