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Items: 1 to 20 of 109

1.

On the shelf life of pharmaceutical products.

Capen R, Christopher D, Forenzo P, Ireland C, Liu O, Lyapustina S, O'Neill J, Patterson N, Quinlan M, Sandell D, Schwenke J, Stroup W, Tougas T.

AAPS PharmSciTech. 2012 Sep;13(3):911-8. doi: 10.1208/s12249-012-9815-2.

2.

Evaluating the performance of the ICH guidelines for shelf life estimation.

Quinlan M, Stroup W, Schwenke J, Christopher D.

J Biopharm Stat. 2013;23(4):881-96. doi: 10.1080/10543406.2013.789889.

PMID:
23786363
3.

On the distribution of batch shelf lives.

Quinlan M, Stroup W, Christopher D, Schwenke J.

J Biopharm Stat. 2013;23(4):897-920. doi: 10.1080/10543406.2013.790039.

PMID:
23786624
4.

Stability analysis with discrete responses.

Chow SC, Shao J.

J Biopharm Stat. 2003 Aug;13(3):451-62.

PMID:
12921393
5.

Significance levels for stability pooling test: a simulation study.

Chen WJ, Tsong Y.

J Biopharm Stat. 2003 Aug;13(3):355-74.

PMID:
12921387
6.

Prediction bounds for random shelf-lives.

Shao J, Chen L.

Stat Med. 1997 May 30;16(10):1167-73.

PMID:
9179981
7.

Uncertainty of measurement and error in stability studies.

Magari RT.

J Pharm Biomed Anal. 2007 Sep 21;45(1):171-5.

PMID:
17590556
8.

Determining shelf life by comparing degradations at elevated temperatures.

Magari RT, Munoz-Antoni I, Baker J, Flagler DJ.

J Clin Lab Anal. 2004;18(3):159-64.

PMID:
15103679
9.

One- and two-stage Arrhenius models for pharmaceutical shelf life prediction.

Fan Z, Zhang L.

J Biopharm Stat. 2015;25(2):307-16. doi: 10.1080/10543406.2014.972743.

PMID:
25358076
10.

Equivalence tests for shelf life and average drug content in stability studies.

Djira GD, Hothorn LA, Tsong Y.

J Biopharm Stat. 2008;18(5):985-95. doi: 10.1080/10543400802287230.

PMID:
18781530
11.

Shelf life determination based on equivalence assessment.

Tsong Y, Chen WJ, Lin TY, Chen CW.

J Biopharm Stat. 2003 Aug;13(3):431-49.

PMID:
12921392
12.
13.

[Shelf-life estimation of pharmaceutical products by matrixing].

Yoshioka S, Aso Y, Kojima S.

Eisei Shikenjo Hokoku. 1996;(114):143-4. Japanese.

PMID:
9037887
14.

Overview of stability study designs.

Lin TY, Chen CW.

J Biopharm Stat. 2003 Aug;13(3):337-54. Review.

PMID:
12921386
15.

Estimation of the shelf-life of drugs with mixed effects models.

Chen JJ, Hwang JS, Tsong Y.

J Biopharm Stat. 1995 Mar;5(1):131-40.

PMID:
7613558
16.

Two-phase shelf-life estimation.

Shao J, Chow SC.

Stat Med. 2001 Apr 30;20(8):1239-48.

PMID:
11304739
17.

Combined statistical analyses for long-term stability data with multiple storage conditions: a simulation study.

Almalik O, Nijhuis MB, van den Heuvel ER.

J Biopharm Stat. 2014;24(3):493-506. doi: 10.1080/10543406.2014.888439.

PMID:
24697656
19.
20.

Estimating drug shelf-life with random batches.

Chow SC, Shao J.

Biometrics. 1991 Sep;47(3):1071-9.

PMID:
1742431

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