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Volumn 24, Issue 3, 1999, Pages 225-232

Bioequivalence studies: Biometrical concepts of alternative designs and pooled analysis

Author keywords

Bioequivalence; Design; Pooled analysis; Regulatory authorities

Indexed keywords

ANTIESTROGEN; TAMOXIFEN;

EID: 0033369822     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190024     Document Type: Article
Times cited : (12)

References (9)
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    • Schuirmann D.J. (1990) : Statistical evaluation of bioequivalence studies. In: Sharma K.N., Sharma K.K., Sen P. Eds. Generic Drugs, Bioequivalence and Pharmacokinetics, UCMS, Delhi, pp 119-125.
    • (1990) Generic Drugs, Bioequivalence and Pharmacokinetics , pp. 119-125
    • Schuirmann, D.J.1
  • 3
    • 0009602751 scopus 로고    scopus 로고
    • Note for guidance on the investigation of bioavailability and bioequivalence
    • Addendum No 2, Guidelines on the Quality, Safety & Efficacy of Medicinal Products for Human Use
    • CPMP :Note for guidance on the investigation of bioavailability and bioequivalence. In: The Rules Governing Medicinal Products for Human Use in the Member States of the European Community, Volume III, Addendum No 2, Guidelines on the Quality, Safety & Efficacy of Medicinal Products for Human Use pp 149-168.
    • The Rules Governing Medicinal Products for Human use in the Member States of the European Community , vol.3 , pp. 149-168
  • 4
    • 0016206702 scopus 로고
    • Bioavailability - A problem in equivalence
    • Metzler C.M. (1974) : Bioavailability - a problem in equivalence. Biometrics, 30, 309-317.
    • (1974) Biometrics , vol.30 , pp. 309-317
    • Metzler, C.M.1
  • 6
    • 0026451765 scopus 로고
    • Sample size determination for bioequivalence assessment by means of confidence intervals
    • Dilleti E., Hauschke D., Steinijans V.W. (1992) : Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol., 29, 51-58,
    • (1992) Int. J. Clin. Pharmacol. Ther. Toxicol. , vol.29 , pp. 51-58
    • Dilleti, E.1    Hauschke, D.2    Steinijans, V.W.3
  • 7
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones B., Jarvis P., Lewis J.A., Ebbutt A.F. (1996) : Trials to assess equivalence: the importance of rigorous methods. BMJ, 313, 36-39.
    • (1996) BMJ , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 8
    • 0003484314 scopus 로고
    • Cambridge: Cambridge University Press
    • Mead R. (1988) : Design of Experiments. Cambridge: Cambridge University Press.
    • (1988) Design of Experiments
    • Mead, R.1
  • 9
    • 0027717908 scopus 로고
    • Report of Consensus Meeting: Biointernational '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic studies
    • Midha K.K, Blume H. (1993) : Report of Consensus Meeting: Biointernational '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic studies. Eur. J. Pharm. Sci., 1, 165-171.
    • (1993) Eur. J. Pharm. Sci. , vol.1 , pp. 165-171
    • Midha, K.K.1    Blume, H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.