메뉴 건너뛰기




Volumn 14, Issue 3, 2004, Pages 311-324

Statistical aspects of long-term stability studies;Aspects statistiques des études de stabilité à long terme

Author keywords

Experimental designs; Long term stability studies; Shelf life; Statistical modelling

Indexed keywords

CALCULATION; DRUG DESIGN; DRUG MANUFACTURE; DRUG SELECTIVITY; DRUG STABILITY; EXPERIMENT; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; MATHEMATICAL MODEL; PROCESS DESIGN; REVIEW; SHELF LIFE; STANDARD;

EID: 4143136536     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (2)

References (22)
  • 6
    • 0003632935 scopus 로고
    • Snedecor G.W and Cochran W.G., The Iowa State University Press, 6th edition
    • «Statistical Methods», Snedecor G.W and Cochran W.G., The Iowa State University Press, 6th edition, 1967.
    • (1967) Statistical Methods
  • 7
    • 0003656150 scopus 로고
    • Draper N.R and Smith H., Wiley Series in Probability and Statistics, 2nd edition
    • «Applied regression analysis», Draper N.R and Smith H., Wiley Series in Probability and Statistics, 2nd edition, 1981.
    • (1981) Applied Regression Analysis
  • 9
    • 0000743845 scopus 로고
    • On biases in estimation due to the use of preliminary tests of significance
    • Bancroft, T. A. «On biases in estimation due to the use of preliminary tests of significance», Annal. Math. Stat. 15:190-204, 1944.
    • (1944) Annal. Math. Stat. , vol.15 , pp. 190-204
    • Bancroft, T.A.1
  • 11
    • 0025994367 scopus 로고
    • Pooling data for stability studies: Testing the equality of batch degradatrion slopes
    • Ruberg S.J. and Stegeman, J.W., «Pooling data for stability studies: testing the equality of batch degradatrion slopes», Biometrics, 47:1059-1069, 1991.
    • (1991) Biometrics , vol.47 , pp. 1059-1069
    • Ruberg, S.J.1    Stegeman, J.W.2
  • 12
    • 0005044961 scopus 로고
    • Multiple comparison procedures for pooling batches in stability studies
    • Ruberg S.J. and Hsu, J.C. «Multiple comparison procedures for pooling batches in stability studies», Technometrics, 34:465-472, 1992.
    • (1992) Technometrics , vol.34 , pp. 465-472
    • Ruberg, S.J.1    Hsu, J.C.2
  • 13
    • 0027994758 scopus 로고
    • Statistical inference in stability analysis
    • Shao, J. and Chow, S.C., «Statistical inference in stability analysis», Biometrics, 50:753-763, 1994.
    • (1994) Biometrics , vol.50 , pp. 753-763
    • Shao, J.1    Chow, S.C.2
  • 15
    • 0030931911 scopus 로고
    • Assessment of shel-life equivalence of pharmaceutical products
    • Yoshioka, S., Aso, Y., and Kojima, S., «Assessment of shel-life equivalence of pharmaceutical products», Chem. Pharm. Bull., 45:1482-1484, 1987.
    • (1987) Chem. Pharm. Bull. , vol.45 , pp. 1482-1484
    • Yoshioka, S.1    Aso, Y.2    Kojima, S.3
  • 16
    • 0027027294 scopus 로고
    • Statistical comparison of stability study designs
    • Nordbrock, E., «Statistical comparison of stability study designs», Journal of Biopharmaceutical Statistics, 2(1), 91-113, 1992.
    • (1992) Journal of Biopharmaceutical Statistics , vol.2 , Issue.1 , pp. 91-113
    • Nordbrock, E.1
  • 17
    • 0026462857 scopus 로고
    • New designs for stability testing programs: Matrix or factiorial designs. Authorities' viewpoint on the predictive value of such studies
    • Helboe P., «New designs for stability testing programs: matrix or factiorial designs. Authorities' viewpoint on the predictive value of such studies», Drug Inf. Journal, 26:629-634, 1992.
    • (1992) Drug Inf. Journal , vol.26 , pp. 629-634
    • Helboe, P.1
  • 18
    • 0030908199 scopus 로고    scopus 로고
    • Shelf-life estimation of mult-factor stability studies
    • Chen J.J., Ahn H., and Tsong Y., «Shelf-life estimation of mult-factor stability studies», Drug Inf. Journal, 31:573-587, 1997.
    • (1997) Drug Inf. Journal , vol.31 , pp. 573-587
    • Chen, J.J.1    Ahn, H.2    Tsong, Y.3
  • 19
    • 0028963688 scopus 로고
    • Estimation of the shelf-life of drugs with mixed effects models
    • Chen J.J., Hwang, J.S., and Tsong Y., «Estimation of the shelf-life of drugs with mixed effects models», Journal of Biopharmaceutical Statistics, 5(1), 131-144, 1995.
    • (1995) Journal of Biopharmaceutical Statistics , vol.5 , Issue.1 , pp. 131-144
    • Chen, J.J.1    Hwang, J.S.2    Tsong, Y.3
  • 20
    • 0028790317 scopus 로고
    • Regulatory, design and analysis aspects of complex stability studies
    • Fairweather, W., Lin, T.D., and Kely R., «Regulatory, design and analysis aspects of complex stability studies», J. Pharm. Sci., 84:1322-1326, 1995.
    • (1995) J. Pharm. Sci. , vol.84 , pp. 1322-1326
    • Fairweather, W.1    Lin, T.D.2    Kely, R.3
  • 22
    • 0043136555 scopus 로고    scopus 로고
    • Special issue on «Recent issues in Stability study»
    • Special issue on «Recent issues in Stability study», Journal of Biopharmaceutical Statistics, Vol. 13, No. 3, 2003.
    • (2003) Journal of Biopharmaceutical Statistics , vol.13 , Issue.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.