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Volumn 3, Issue 1, 2004, Pages 3-11

A new approach to estimating shelf-life

Author keywords

Constraint; Modified profile likehood; Quantile; Shelf life; Stability analysis

Indexed keywords

DRUG;

EID: 10644277211     PISSN: 15391604     EISSN: None     Source Type: Journal    
DOI: 10.1002/pst.78     Document Type: Article
Times cited : (17)

References (9)
  • 1
    • 10644221581 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1A(R2), Step 4, 6 February
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Stability testing of new drug substances and products, Q1A(R2), Step 4, 6 February 2003.
    • (2003) Stability Testing of New Drug Substances and Products
  • 2
    • 10644293007 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. QIE, Step 2, 7 February
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Evaluation of Stability Data, QIE, Step 2, 7 February 2002.
    • (2002) Evaluation of Stability Data
  • 3
    • 10644284349 scopus 로고
    • Estimating drug shelf-life in NDA stability studies
    • American Statistical Association, Alexandria, VA
    • Chow SC, Shao J. Estimating drug shelf-life in NDA stability studies. In: ASA Proceedings of the Biopharmaceutical Section. American Statistical Association, Alexandria, VA, 1990, pp. 190-195.
    • (1990) ASA Proceedings of the Biopharmaceutical Section , pp. 190-195
    • Chow, S.C.1    Shao, J.2
  • 4
    • 0027994758 scopus 로고
    • Statistical inference in stability analysis
    • Shao J, Chow SC. Statistical inference in stability analysis. Biometrics 1994; 50:753-763.
    • (1994) Biometrics , vol.50 , pp. 753-763
    • Shao, J.1    Chow, S.C.2
  • 5
    • 0017294321 scopus 로고
    • Terminology regarding labeled and contained amounts in dosage forms
    • Carstensen JT, Nelson E. Terminology regarding labeled and contained amounts in dosage forms. Journal of Pharmaceutical Sciences 1976; 65(2): 311-312.
    • (1976) Journal of Pharmaceutical Sciences , vol.65 , Issue.2 , pp. 311-312
    • Carstensen, J.T.1    Nelson, E.2
  • 7
    • 0000072546 scopus 로고
    • On a formula for the distribution of the maximum likelihood estimator
    • Barndorff-Nielsen OE. On a formula for the distribution of the maximum likelihood estimator. Biometrika 1983; 70 2):343-365.
    • (1983) Biometrika , vol.70 , Issue.2 , pp. 343-365
    • Barndorff-Nielsen, O.E.1
  • 8
    • 0002738159 scopus 로고
    • Parameter orthogonality and approximate conditional inference
    • (with discussion)
    • Cox DR, Reid N. Parameter orthogonality and approximate conditional inference (with discussion). Journal of the Royal Statistical Society, Series B 1987; 49:1-39.
    • (1987) Journal of the Royal Statistical Society Series B , vol.49 , pp. 1-39
    • Cox, D.R.1    Reid, N.2
  • 9
    • 10644268087 scopus 로고    scopus 로고
    • A new approach to estimating shelf-life
    • BiometricsSA, University of Adelaide/SARDI
    • Kiermeier A, Verbyla AP. A new approach to estimating shelf-life. Research Report 2002/R4, BiometricsSA, University of Adelaide/SARDI, 2002.
    • (2002) Research Report 2002/R4
    • Kiermeier, A.1    Verbyla, A.P.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.