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Volumn 32, Issue 3, 2010, Pages 588-596

Pharmacokinetics and bioequivalence study of three oral formulations of valsartan 160 mg: A single-dose, randomized, open-label, three-period crossover comparison in healthy Indian male volunteers

Author keywords

Bioequivalence; HPLC method; Pharmacokinetics; Valsartan

Indexed keywords

GENERIC DRUG; UNCLASSIFIED DRUG; VALENT; VALSARTAN; VALZAAR;

EID: 77951950634     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.03.004     Document Type: Article
Times cited : (23)

References (24)
  • 1
    • 20344361935 scopus 로고    scopus 로고
    • Potential savings from substituting generic drugs for brand-name drugs: Medical expenditure panel survey, 1997-2000
    • Haas JS, Phillips KA, Gerstenberger EP, Seger AC Potential savings from substituting generic drugs for brand-name drugs: Medical expenditure panel survey, 1997-2000. Ann Intern Med. 2005, 142:891-897.
    • (2005) Ann Intern Med. , vol.142 , pp. 891-897
    • Haas, J.S.1    Phillips, K.A.2    Gerstenberger, E.P.3    Seger, A.C.4
  • 2
    • 3242805997 scopus 로고    scopus 로고
    • Generic drugs in cardiology: Will they reduce health care costs?
    • Pitt B Generic drugs in cardiology: Will they reduce health care costs?. J Am Coll Cardiol. 2004, 44:10-13.
    • (2004) J Am Coll Cardiol. , vol.44 , pp. 10-13
    • Pitt, B.1
  • 3
    • 0009863479 scopus 로고    scopus 로고
    • BNF recommendations of substitution: Are they followed in practice?
    • Marriott JF BNF recommendations of substitution: Are they followed in practice?. Pharm J. 1999, 263:289-292.
    • (1999) Pharm J. , vol.263 , pp. 289-292
    • Marriott, J.F.1
  • 4
    • 35048880552 scopus 로고    scopus 로고
    • Maximising generic utilisation: The power of pharmacy benefit management
    • Snow Jr DB Maximising generic utilisation: The power of pharmacy benefit management. J Gen Med. 2007, 5:27-38.
    • (2007) J Gen Med. , vol.5 , pp. 27-38
    • Snow Jr, D.B.1
  • 5
    • 0029861308 scopus 로고    scopus 로고
    • Generic drugs. Therapeutic equivalence
    • Meredith PA Generic drugs. Therapeutic equivalence. Drug Saf. 1996, 15:223-242.
    • (1996) Drug Saf. , vol.15 , pp. 223-242
    • Meredith, P.A.1
  • 6
    • 0033810627 scopus 로고    scopus 로고
    • Dissolution and in vivo evidence of differences in reference products: Impact on development of generic drugs
    • Spino M, Tsang Y, Pop R Dissolution and in vivo evidence of differences in reference products: Impact on development of generic drugs. Eur J Drug Metab Pharmacokinet. 2000, 25:18-24.
    • (2000) Eur J Drug Metab Pharmacokinet. , vol.25 , pp. 18-24
    • Spino, M.1    Tsang, Y.2    Pop, R.3
  • 7
    • 0642275657 scopus 로고    scopus 로고
    • WHO tries to tackle problem of counterfeit medicines in Asia
    • Pincock S WHO tries to tackle problem of counterfeit medicines in Asia. BMJ. 2003, 327:1126.
    • (2003) BMJ. , vol.327 , pp. 1126
    • Pincock, S.1
  • 8
    • 35549003151 scopus 로고    scopus 로고
    • Counterfeit and substandard quality of drugs: The need for an effective and stringent regulatory control in India and other developing countries
    • Khan AY, Ghilzai NM Counterfeit and substandard quality of drugs: The need for an effective and stringent regulatory control in India and other developing countries. Ind J Pharmacol. 2007, 39:206-207.
    • (2007) Ind J Pharmacol. , vol.39 , pp. 206-207
    • Khan, A.Y.1    Ghilzai, N.M.2
  • 9
    • 44849114302 scopus 로고    scopus 로고
    • Bioequivalence and pharmacokinetics of two zidovudine formulations in healthy Brazilian volunteers: An openlabel, randomized, single-dose, two-way crossover study
    • Dos Reis Serra CH, Mori Koono EE, Kano EK, et al. Bioequivalence and pharmacokinetics of two zidovudine formulations in healthy Brazilian volunteers: An openlabel, randomized, single-dose, two-way crossover study. Clin Ther. 2008, 30:902-908.
    • (2008) Clin Ther. , vol.30 , pp. 902-908
    • Dos Reis Serra, C.H.1    Mori Koono, E.E.2    Kano, E.K.3
  • 10
    • 0003455042 scopus 로고    scopus 로고
    • US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Accessed November 13, 2008
    • Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Accessed November 13, 2008. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsar eDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplication ANDAGenerics/UCM154838.pdf.
    • Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations
  • 11
    • 85028350802 scopus 로고    scopus 로고
    • Central Drugs Standard Control Organization, Directorate General of Health ServicesDirectorate General of Health Services, Ministry of Health & Family WelfareMinistry of Health & Family Welfare, Accessed November 13, 2008
    • Guidelines for bioavailability & bioequivalence studies Central Drugs Standard Control Organization, Directorate General of Health ServicesDirectorate General of Health Services, Ministry of Health & Family WelfareMinistry of Health & Family Welfare, Accessed November 13, 2008. http://www.cdsco.nic.in/htmL/BE%20Guidelines%20Draft%20Ver10%20March%201 6,%2005.pdf.
    • Guidelines for bioavailability & bioequivalence studies
  • 13
    • 0033662758 scopus 로고    scopus 로고
    • International harmonisation of bioequivalence studies and issues shared in common
    • Nakai K, Fujita M, Ogata H International harmonisation of bioequivalence studies and issues shared in common. Yakugaku Zasshi. 2000, 120:1193-1200.
    • (2000) Yakugaku Zasshi. , vol.120 , pp. 1193-1200
    • Nakai, K.1    Fujita, M.2    Ogata, H.3
  • 14
    • 0030750293 scopus 로고    scopus 로고
    • Valsartan. A review of its pharmacology and therapeutic use in essential hypertension
    • Markham A, Goa KL Valsartan. A review of its pharmacology and therapeutic use in essential hypertension. Drugs. 1997, 54:299-311.
    • (1997) Drugs. , vol.54 , pp. 299-311
    • Markham, A.1    Goa, K.L.2
  • 15
    • 55749092220 scopus 로고    scopus 로고
    • Novartis Pharmaceuticals Corporation, East Hanover, NJ
    • Diovan [prescribing information] 2007, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
    • (2007) Diovan [prescribing information]
  • 16
    • 0030896929 scopus 로고    scopus 로고
    • Protein binding in plasma of valsartan, a new angiotensin II receptor antagonist
    • Colussi DM, Parisot C, Rossolino ML, et al. Protein binding in plasma of valsartan, a new angiotensin II receptor antagonist. J Clin Pharmacol. 1997, 37:214-221.
    • (1997) J Clin Pharmacol. , vol.37 , pp. 214-221
    • Colussi, D.M.1    Parisot, C.2    Rossolino, M.L.3
  • 17
    • 0030979588 scopus 로고    scopus 로고
    • Absolute bioavailability and pharmacokinetics of valsartan, an angiotensin II receptor antagonist, in man
    • Flesch G, Müller P, Lloyd P Absolute bioavailability and pharmacokinetics of valsartan, an angiotensin II receptor antagonist, in man. Eur J Clin Pharmacol. 1997, 52:115-120.
    • (1997) Eur J Clin Pharmacol. , vol.52 , pp. 115-120
    • Flesch, G.1    Müller, P.2    Lloyd, P.3
  • 19
    • 0030767096 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamic effects of the angiotensin II antagonist valsartan at steady state in healthy, normotensive subjects
    • Müller P, Flesch G, de Gasparo M, et al. Pharmacokinetics and pharmacodynamic effects of the angiotensin II antagonist valsartan at steady state in healthy, normotensive subjects. Eur J Clin Pharmacol. 1997, 52:441-449.
    • (1997) Eur J Clin Pharmacol. , vol.52 , pp. 441-449
    • Müller, P.1    Flesch, G.2    de Gasparo, M.3
  • 20
    • 0031980805 scopus 로고    scopus 로고
    • The effect of age on the pharmacokinetics of valsartan
    • Sioufi A, Marfil F, Jaouen A, et al. The effect of age on the pharmacokinetics of valsartan. Biopharm Drug Dispos. 1998, 19:237-244.
    • (1998) Biopharm Drug Dispos. , vol.19 , pp. 237-244
    • Sioufi, A.1    Marfil, F.2    Jaouen, A.3
  • 21
    • 0036156871 scopus 로고    scopus 로고
    • Bioequivalence study of a valsartan tablet and a capsule formulation after single dosing in healthy volunteers using a replicated crossover design
    • Séchaud R, Graf P, Bigler H, et al. Bioequivalence study of a valsartan tablet and a capsule formulation after single dosing in healthy volunteers using a replicated crossover design. Int J Clin Pharmacol Ther. 2002, 40:35-40.
    • (2002) Int J Clin Pharmacol Ther. , vol.40 , pp. 35-40
    • Séchaud, R.1    Graf, P.2    Bigler, H.3
  • 22
    • 33745627737 scopus 로고    scopus 로고
    • A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs tablets
    • Pérez M, Cardenas W, Quim GR, et al. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs tablets. Revista Colombia Médica. 2006, 37:114-120.
    • (2006) Revista Colombia Médica. , vol.37 , pp. 114-120
    • Pérez, M.1    Cardenas, W.2    Quim, G.R.3
  • 23
    • 72149114614 scopus 로고    scopus 로고
    • Results of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions
    • Franco Spínola AC, Almeida S, Filipe A, et al. Results of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions. Clin Ther. 2009, 31:1992-2001.
    • (2009) Clin Ther. , vol.31 , pp. 1992-2001
    • Franco Spínola, A.C.1    Almeida, S.2    Filipe, A.3
  • 24
    • 0003484310 scopus 로고    scopus 로고
    • US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM)Center for Veterinary Medicine (CVM), Accessed November 13, 2008
    • Guidance for Industry. Bioanalytical method validation US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM)Center for Veterinary Medicine (CVM), Accessed November 13, 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM070107.pdf.
    • Guidance for Industry. Bioanalytical method validation


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.