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Volumn 16, Issue 2, 2010, Pages 103-114

How sequential studies inform drug development: Evaluating the effect of Food intake on optimal bioavailability of ziprasidone

Author keywords

Antipsychotics; Bioavailability; Clinical trial design; Drug development; Food intake; Ziprasidone

Indexed keywords

ZIPRASIDONE;

EID: 77952182765     PISSN: 15274160     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.pra.0000369971.64908.dc     Document Type: Article
Times cited : (23)

References (18)
  • 2
    • 0242350785 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research CDER , Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER;, available at, accessed November 5
    • Center for Drug Evaluation and Research (CDER). Guidance for industry: Food-effect bioavailability and fed bioequivalence studies. Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER; 2002 (available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM126833pdf. accessed November 5, 2009).
    • (2002) Guidance for Industry: Food-effect Bioavailability and Fed Bioequivalence Studies
  • 3
    • 0003455042 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research CDER , Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER; March, available at, accessed November 5
    • Center for Drug Evaluation and Research (CDER). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products: General considerations. Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER; March 2003 (available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070124pdf, accessed November 5, 2009).
    • (2003) Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations
  • 4
    • 0003922013 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research CDER , Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER; January, available at, accessed November 5
    • Center for Drug Evaluation and Research (CDER). Guidance for industry: Statistical approaches to establishing bioequivalence. Rockville, MD: U. S. Department of Health and Human Services, Food and Drug Administration, CDER; January 2001 (available at www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInform ation/Guidances/ucm070244pdf, accessed November 5, 2009).
    • (2001) Guidance for Industry: Statistical Approaches to Establishing Bioequivalence
  • 5
    • 0031984632 scopus 로고    scopus 로고
    • The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone
    • Hamelin BA, Allard S, Laplante L, et al. The effect of timing of a standard meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic agent ziprasidone. Pharmacotherapy 1998;18:9-15.
    • (1998) Pharmacotherapy , vol.18 , pp. 9-15
    • Hamelin, B.A.1    Allard, S.2    Laplante, L.3
  • 6
    • 44849131431 scopus 로고    scopus 로고
    • The effect of food on the absorption of oral ziprasidone
    • Miceli JJ, Glue P, Alderman J, et al. The effect of food on the absorption of oral ziprasidone. Psychopharmacol Bull 2007;40:58-68.
    • (2007) Psychopharmacol Bull. , vol.40 , pp. 58-68
    • Miceli, J.J.1    Glue, P.2    Alderman, J.3
  • 7
    • 60349093506 scopus 로고    scopus 로고
    • The impact of calories and fat content of meals on oral ziprasidone absorption: A randomized, open-label, crossover trial
    • Gandelman K, Alderman JA, Glue P, et al. The impact of calories and fat content of meals on oral ziprasidone absorption: A randomized, open-label, crossover trial. J Clin Psychiatry 2009;70:58-62.
    • (2009) J. Clin. Psychiatry , vol.70 , pp. 58-62
    • Gandelman, K.1    Alderman, J.A.2    Glue, P.3
  • 8
    • 75149139977 scopus 로고    scopus 로고
    • Patients who do not respond to the "usual" dose: Why Terry fell off the dose-response curve
    • Preskorn SH. Patients who do not respond to the "usual" dose: Why Terry fell off the dose-response curve. J Psychiatr Pract 2009;15:460-6.
    • (2009) J. Psychiatr. Pract. , vol.15 , pp. 460-6
    • Preskorn, S.H.1
  • 9
    • 36349037117 scopus 로고    scopus 로고
    • Clinical relevance of relative receptor binding affinity: Quetiapine and ziprasidone as examples
    • Preskorn SH. Clinical relevance of relative receptor binding affinity: Quetiapine and ziprasidone as examples. J Psychiatr Pract 2007;13:393-8.
    • (2007) J. Psychiatr. Pract. , vol.13 , pp. 393-8
    • Preskorn, S.H.1
  • 10
    • 34547144304 scopus 로고    scopus 로고
    • Translating the psychopharmacology of antipsychotics to individualized treatment for severe mental illness: A roadmap
    • Weiden PJ, Preskorn SH, Fahnestock PA, et al. Translating the psychopharmacology of antipsychotics to individualized treatment for severe mental illness: A roadmap. J Clin Psychiatry 2007; 68 (suppl 7) : 1-46.
    • (2007) J. Clin. Psychiatry , vol.68 , Issue.7 SUPPL. , pp. 1-46
    • Weiden, P.J.1    Preskorn, S.H.2    Fahnestock, P.A.3
  • 11
    • 2442457725 scopus 로고    scopus 로고
    • A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone
    • Mamo D, Kapur S, Shammi CM, et al. A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone, Am J Psychiatry 2004;161:818-25.
    • (2004) Am J Psychiatry , vol.161 , pp. 818-25
    • Mamo, D.1    Kapur, S.2    Shammi, C.M.3
  • 13
    • 0027520871 scopus 로고
    • Central D2-dopamine receptor occupancy in relation to antipsychotic drug effects: A double-blind PET study of schizophrenic patients
    • Nordstrom AL, Farde L, Wiesel FA, et al. Central D2-dopamine receptor occupancy in relation to antipsychotic drug effects: A double-blind PET study of schizophrenic patients. Biol Psychiatry 1993;33:227-35.
    • (1993) Biol. Psychiatry , vol.33 , pp. 227-35
    • Nordstrom, A.L.1    Farde, L.2    Wiesel, F.A.3
  • 14
    • 0030574074 scopus 로고    scopus 로고
    • Test-retest reliability of central [11C]raclopride binding at high D2 receptor occupancy
    • Nyberg S, Farde L, Halldin C. Test-retest reliability of central [11C]raclopride binding at high D2 receptor occupancy. Psychiatry Res 1996;67:163-71.
    • (1996) Psychiatry Res. , vol.67 , pp. 163-71
    • Nyberg, S.1    Farde, L.2    Halldin, C.3
  • 15
    • 0031927910 scopus 로고    scopus 로고
    • An exploratory haloperidolcontrolled dose-finding study of ziprasidone in hospitalized patients with schizophrenia or schizoaffective disorder
    • Goff DC, Posever T, Herz L. An exploratory haloperidolcontrolled dose-finding study of ziprasidone in hospitalized patients with schizophrenia or schizoaffective disorder. J Clin Psychopharmacol 1998;18:296-304.
    • (1998) J. Clin. Psychopharmacol , vol.18 , pp. 296-304
    • Goff, D.C.1    Posever, T.2    Herz, L.3
  • 16
    • 33846975815 scopus 로고    scopus 로고
    • Metabolic considerations in the use of antipsychotic medications: A review of recent evidence
    • Newcomer JW. Metabolic considerations in the use of antipsychotic medications: A review of recent evidence. J Clinical Psychiatry 2007; 68 (suppl 1) : 20-7.
    • (2007) J. Clinical Psychiatry , vol.68 , Issue.1 SUPPL. , pp. 20-7
    • Newcomer, J.W.1
  • 17
    • 28844485754 scopus 로고    scopus 로고
    • Schizophrenia and increased risks of cardiovascular disease
    • Hennekens CH, Hennekens AR, Hollar D, et al. Schizophrenia and increased risks of cardiovascular disease, Am Heart J 2005;150:1115-21.
    • (2005) Am. Heart J. , vol.150 , pp. 1115-21
    • Hennekens, C.H.1    Hennekens, A.R.2    Hollar, D.3
  • 18
    • 73449097085 scopus 로고    scopus 로고
    • Using oral ziprasidone effectively: The food effect and dose response
    • Citrome L. Using oral ziprasidone effectively: The food effect and dose response. Adv Ther 2009;26:739-48.
    • (2009) Adv. Ther. , vol.26 , pp. 739-48
    • Citrome, L.1


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