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Drug Development and Industrial Pharmacy Volume 33, 2007 - Issue 12
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Research Article

Comparative Study on the Bioequivalence of Two Formulations of Pioglitazone Tablet in Healthy Thai Male Volunteers

Pattana Sripalakit Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Sirada Maphanta Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Penporn Neamhom Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Aurasorn Saraphanchotiwitthaya Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Sanglar Polnok Faculty of Nursing, Naresuan University, Phitsanulok, Thailand
&
Dhirayudh Yokubol Naresuan University Hospital, Naresuan University, Phitsanulok, Thailand
Pages 1362-1368 | Published online: 25 Sep 2008

REFERENCES

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  • Diletti E., Hauschke D., Steinijans V. W. Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 1991; 29(1)1–8,
  • Eckland D. A., Danhof M. Clinical pharmacokinetics of pioglitazone. Exp. Clin. Endocrinol. Diabetes 2000; 108(2)234–242, 10.1055/s-2000-8525
  • Hanefeld M. Pharmacokinetics and clinical efficacy of pioglitazone. Int. J. Clin. Pract. Suppl., 121: 19–25, 10.1055/s-2000-8525
  • Sripalakit P., Neamhom P., Saraphanchotiwitthaya A. High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study. J. Chrom. B 2006; 843(2)164–169, 10.1016/j.jchromb.2006.05.032
  • Takeda Pharmaceutical Co. Ltd. Actos® (pioglitazone hydrochloride) full prescribing information. OsakaJapan 2004,
  • www.app1.fda.moph.go.th/be/guideline/Thailand/BABE/guideline.doc Thailand Food and Drug Administration. (2001). Guidelines for the conduct of bioavailability and bioequivalence studies. Drug Control Division, Ministry of Public Health, Thailand
  • www.springerlink.com/index/V628675G42232436.pdf US Food and Drug Administration. (2000). Guidance for industry: Bioavailability and bioequivalence studies for administered drug products-general considerations. Center for Drug Evaluation and Research, Rockville, MD.
  • Waugh J., Keating G. M., Plosker G. L., Easthope S., Robinson D. M. Pioglitazone: A review of its use in type 2 diabetes mellitus. Drugs 2006; 66(1)85–109,
  • Wong H., Ozalp Y., Lainesse A., Alpan R. S. In vivo bioequivalence of oral antidiabetic agents: pioglitazone tablets. Arzneimittelforschung 2004; 54(9)618–624,
  • www.pharmexcil.com/v1/docs/TechSes-I/8 World Health Organization. (2005). Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Switzerland

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