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Volumn 17, Issue 1, 2007, Pages 143-157

Parametric two-stage sequential quality assurance test of dose content uniformity

Author keywords

Dose content uniformity; Double one sided test; Tolerance interval; Two stage group sequential; US Pharmacopeia

Indexed keywords

ANALYSIS OF VARIANCE; ARTICLE; DOSE CONTENT UNIFORMITY; DRUG OVERDOSE; DRUG SAFETY; PARAMETRIC TEST; PHARMACY; PRIORITY JOURNAL; PROBABILITY; QUALITY CONTROL; RECEIVER OPERATING CHARACTERISTIC; TABLET FORMULATION;

EID: 33845799651     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400601001527     Document Type: Article
Times cited : (17)

References (9)
  • 1
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    • Strasbourg, France: Council of European Dept. for the Quality of Medicines, Council of Europe
    • European Pharmacopoeia. (1996). 3rd ed. Strasbourg, France: Council of European Dept. for the Quality of Medicines, Council of Europe.
    • (1996) European Pharmacopoeia. 3rd Ed.
  • 2
    • 0001700356 scopus 로고
    • Sample size for tolerance limits on a normal distribution
    • Faulkenberry, G. D., Daley, J. C. (1970). Sample size for tolerance limits on a normal distribution. Technometrics 12(4):813-821.
    • (1970) Technometrics , vol.12 , Issue.4 , pp. 813-821
    • Faulkenberry, G.D.1    Daley, J.C.2
  • 4
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan, K. K. G., DeMets, L. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70:659-63.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, L.L.2
  • 6
    • 34047200744 scopus 로고    scopus 로고
    • Uniformity of Dosage Units
    • Uniformity of Dosage Units, United States Pharmacopeia. (2005). pp. 2505-2510.
    • (2005) United States Pharmacopeia. , pp. 2505-2510
  • 8
    • 4644303117 scopus 로고    scopus 로고
    • Three-stage sequential statistical dissolution testing rules
    • Tsong, Y., Shen, M., Shah, V. P. (2004). Three-stage sequential statistical dissolution testing rules. J. Biopharm Stat. 14(3):757-779.
    • (2004) J. Biopharm Stat. , vol.14 , Issue.3 , pp. 757-779
    • Tsong, Y.1    Shen, M.2    Shah, V.P.3
  • 9
    • 33845810798 scopus 로고    scopus 로고
    • Easton, Penn: Mack Printing Company
    • U.S. Pharmacopoeia XXIV. (2005). Easton, Penn: Mack Printing Company.
    • (2005) U.S. Pharmacopoeia XXIV


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.