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Volumn 18, Issue 3, 2004, Pages 159-164

Determining Shelf Life by Comparing Degradations at Elevated Temperatures

Author keywords

Accelerated stability; Modeling; Shelf life; Statistics

Indexed keywords

BIOLOGICAL PRODUCT;

EID: 2342513463     PISSN: 08878013     EISSN: None     Source Type: Journal    
DOI: 10.1002/jcla.20016     Document Type: Article
Times cited : (14)

References (7)
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    • (1984) J Pharm Sci , vol.73 , pp. 185-190
    • King, S.P.1    Kung, M.2    Fung, H.3
  • 2
    • 0021669493 scopus 로고
    • Design and analysis of accelerated degradation tests for the stability of biological standards. I. Properties of maximum likelihood estimators
    • Tydeman MS, Kirkwood TBL. Design and analysis of accelerated degradation tests for the stability of biological standards. I. Properties of maximum likelihood estimators. J Biol Stand 1984;12:195-206.
    • (1984) J Biol Stand , vol.12 , pp. 195-206
    • Tydeman, M.S.1    Kirkwood, T.B.L.2
  • 3
    • 0032071686 scopus 로고    scopus 로고
    • Accelerated degradation tests: Modeling and analysis
    • Meeker WQ, Escobar LA, Lu CJ. Accelerated degradation tests: modeling and analysis. Technometrics 1998;40:89-99.
    • (1998) Technometrics , vol.40 , pp. 89-99
    • Meeker, W.Q.1    Escobar, L.A.2    Lu, C.J.3
  • 4
    • 0035155731 scopus 로고    scopus 로고
    • Stability parameter estimation at ambient temperature from studies at elevated temperatures
    • Some IT, Bogaerts P, Hanus R, Hanocq M, Dubois J. Stability parameter estimation at ambient temperature from studies at elevated temperatures. J Pharm Sci 2000;90:1759-1766.
    • (2000) J Pharm Sci , vol.90 , pp. 1759-1766
    • Some, I.T.1    Bogaerts, P.2    Hanus, R.3    Hanocq, M.4    Dubois, J.5
  • 5
    • 0036281906 scopus 로고    scopus 로고
    • Estimating degradation in real-time and accelerated stability tests with random lot-to-lot variation: A simulation study
    • Magari RT. Estimating degradation in real-time and accelerated stability tests with random lot-to-lot variation: a simulation study. J Pharm Sci 2002;91:893-899.
    • (2002) J Pharm Sci , vol.91 , pp. 893-899
    • Magari, R.T.1
  • 6
    • 84946045727 scopus 로고
    • Approximations to the log-likelihood function in the non-linear mixed-effects model
    • Pinheiro JC, Bates DM. Approximations to the log-likelihood function in the non-linear mixed-effects model. Comput Graph Stat 1995;4:12-35.
    • (1995) Comput Graph Stat , vol.4 , pp. 12-35
    • Pinheiro, J.C.1    Bates, D.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.