Bioequivalence model for evaluation of Losartan in human plasma with special reference to drug–metabolite ratio

References

• Timmermans PBMWM, Wong PC, Chiu AT, Herblin WF, Benfield P, Carini DJ, Lee RJ, Wexler RR, Saye JAM, Smith RD. Angiotensin II receptors and angiotensin II receptor antagonists. Pharmacol Rev 1993;45:205–251.
   PubMed Web of Science ®Google Scholar
• Munafo A, Christen Y, Nussberger J, Shum LY, Borland RM, Lee RJ, Waeber B, Biollaz J, Brunner HR. Drug concentration response relationship in normal volunteers after oral administration of losartan, an angiotensin II receptor antagonist. Clin Pharmacol Ther 1992;51:513–521.
   PubMed Web of Science ®Google Scholar
• Lo MW, Goldberg MR, McCrea JB, Lu H, Furtek CI, Bjornsson TD. Pharmacokinetics of losartan, an angiotensin II receptor antagonist, and its active metabolite EXP3174 in humans. Clin Pharmacol Ther 1995;58:641–649.
   PubMed Web of Science ®Google Scholar
• Sica DA, Gehr TW, Ghosh S. Clinical pharmacokinetics of losartan. Clin Pharmacokinet 2005;44:797–814.
   PubMed Web of Science ®Google Scholar
• Munafo A, Christen Y, Nussberger J, Shum LY, Borland RM, Lee RJ, Waeber B, Biollaz J, Brunner HR Drug concentration response relationship in normal volunteers after oral administration of losartan, an angiotensin II receptor antagonist. Clin Pharmacol Ther 1992;51:513–521.
   PubMed Web of Science ®Google Scholar
• Ohtawal M, Takayama F, Saitoh K, Yoshinaga T, Nakashima M. Pharmacokinetics and biochemical efficacy after single and multiple oral administration of losartan, an orally active nonpeptide angiotensin II receptor antagonist, in humans. Br J Clin Pharm 1993;35:290–297.
   PubMed Web of Science ®Google Scholar
• Kolocouri F, Dotsikas Y, Apostolou C, Kousoulos C, Loukas YL. Simultaneous determination of losartan, EXP-3174 and hydrochlorothiazide in plasma via fully automated 96-well-format-based solid-phase extraction and liquid chromatography–negative electrospray tandem mass spectrometry. Anal Bioanal Chem 2007;387:593–601.
   PubMed Web of Science ®Google Scholar
• Tamimi JJI, Salema II, Alamb SM, Zamanb Q, Dhamb R. Comparative pharmacokinetics of two tablet formulations of Losartan: bioequivalence assessment. Biopharm Drug Dispos 2005;26: 205–210.
   PubMed Web of Science ®Google Scholar
• Prasaja B, Sasongko L, Harahap Y, Hardiyanti Lusthom W, Grigg M. Simultaneous quantification of losartan and active metabolite in human plasma by liquid chromatography—tandem mass spectrometry using irbesartan as internal standard. J Pharm Biomed Anal 2009;49:862–867.
   PubMed Web of Science ®Google Scholar
• Dickson TZ, Zagrobelny JA, Lin CC, Ritter MA, Snavely D, Ramjit D, Shahinfar S, Lo MWJ. Pharmacokinetics, safety, and antihypertensive efficacy of losartan in combination with hydrochlorothiazide in hypertensive patients with renal impairment. Clin Pharmacol 2003;43:591.
   Google Scholar
• Sandwall P, Lo MW, Jonzon B, Furtek PDC, Ritter MA, AlvanG, McCrea J, Sjoqvist F. Lack of polymorphism of the conversion of losartan to its active metabolite E-3174 in extensive and poor metabolizers of debrisoquine (cytochrome P450 2D6) and mephenytoin (cytochrome P450 2C19). Eur J Clin Pharmacol 1999;55:279–283.
   PubMed Web of Science ®Google Scholar
• Agnieszka B, Rafal B, Edyta S, Vitali D, Edmund G, Stanislaw D, Leon D, Anna W, Magdalena OR. Bioequivalence study of two losartan formulations administered orally in healthy male volunteers. Arzneimittel-Forschung (Arzneimittelforschung) 2006;56:723–728.
   PubMed Web of Science ®Google Scholar
• Neves R, Almeida S, Filipe A, Spínola AC, Abolfathi Z, Yritia M, Ortuño J. Bioequivalence study of two different film-coated tablet formulations of losartan-hydrochlorothiazide in healthy volunteers. Arzneimittelforschung 2008;58:369–375.
   PubMed Web of Science ®Google Scholar
• Goswami D, Kumar A, Khuroo AH, Monif T, Thudi NR, Shrivastav VK, Dubey SK, Shingla AK, Prakash M, Mehra S. Pharmacokinetic estimation of losartan, losartan carboxylic acid and hydrochlorothiazide in human plasma by LC/MS/MS validated method. Clin Res Regul Affairs 2008;25:235–258.
   Google Scholar
• Schuirmann DJ. A comparison of two one-sided test procedure and the power approach for assessing the equivalence of the average bioavailability. J Pharmacokinet Biopharm 1987;15:657–680.
   PubMedGoogle Scholar
• Chow CS, Liu JP. Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker; 1992.
   Google Scholar
• Food and Drug Administration. Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products—General considerations. March, 2003. Available online at: www.fda.gov/cder/guidance/5356fnl.pdf, accessed February 22, 2009.
   Google Scholar
• Validation of analytical procedures: Methodology, ICH-Q2B, International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Geneva, Switzerland; 1996. Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology; 1996. http://www.fda.gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/ucm. 073384.pdf
   Google Scholar
• Raghavan K, Dwivedi A, Campbell Jr GC, Johnston E, Levorse D, McCauley J, Hussian MA. Spectroscopic investigation of losartan polymorphs. Pharm Res 1993;6:900–904.
   Google Scholar
• Patočka J, Dvořák A. Biomedical aspects of chiral molecules. J Appl Biomed 2004;2:95–100.
   Google Scholar
• Caldwell J. Do single enantiomers have something special to offer? Hum Psycopharmacol Clin Exp 2001;16:S67–S71.
   PubMed Web of Science ®Google Scholar
• Lin Y, Lu P, Tang C, Mei Q, Sandig G, Rodrigues AD, Rushmore TH, Shou M. Substrate inhibition kinetics for cytochrome P-450-catalyzed reactions. Drug Metab Dispos 2001;29:368–374.
   PubMed Web of Science ®Google Scholar