These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
8. International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2003 Jan; 68(11):2339-40. PubMed ID: 12532979 [TBL] [Abstract][Full Text] [Related]
9. Estimating drug shelf-life with random batches. Chow SC; Shao J Biometrics; 1991 Sep; 47(3):1071-9. PubMed ID: 1742431 [TBL] [Abstract][Full Text] [Related]
10. An alternative approach to evaluation of poolability for stability studies. Liu JP; Tung SC; Pong YM J Biopharm Stat; 2006; 16(1):1-14. PubMed ID: 16440833 [TBL] [Abstract][Full Text] [Related]
11. Comparing distributions of shelf lives for drug products with two components under different designs. Pon A; Raghavarao D J Biopharm Stat; 2002 Aug; 12(3):277-93. PubMed ID: 12448571 [TBL] [Abstract][Full Text] [Related]
12. 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. PubMed ID: 23786363 [TBL] [Abstract][Full Text] [Related]
13. Estimating shelf-life of drugs in solution. Newton DW; Miller KW Am J Hosp Pharm; 1987 Jul; 44(7):1633-40. PubMed ID: 3631095 [TBL] [Abstract][Full Text] [Related]
14. ANCOVA approach for shelf life analysis of stability study of multiple factor designs. Tsong Y; Chen WJ; Chen CW J Biopharm Stat; 2003 Aug; 13(3):375-93. PubMed ID: 12921388 [TBL] [Abstract][Full Text] [Related]
15. Stability analysis for drugs with multiple active ingredients. Chow SC; Shao J Stat Med; 2007 Mar; 26(7):1512-7. PubMed ID: 16955533 [TBL] [Abstract][Full Text] [Related]
16. 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. PubMed ID: 18781530 [TBL] [Abstract][Full Text] [Related]
18. Shelf life determination based on equivalence assessment. Tsong Y; Chen WJ; Lin TY; Chen CW J Biopharm Stat; 2003 Aug; 13(3):431-49. PubMed ID: 12921392 [TBL] [Abstract][Full Text] [Related]
19. [Assessment of stability variation among batches, packaging, and formulations--application of matrixing and bracketing]. Yoshioka S; Aso Y; Kojima S Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 1998; (116):192-4. PubMed ID: 10097539 [TBL] [Abstract][Full Text] [Related]
20. Evaluating Current Practices in Shelf Life Estimation. Capen R; Christopher D; Forenzo P; Huynh-Ba K; LeBlond D; Liu O; O'Neill J; Patterson N; Quinlan M; Rajagopalan R; Schwenke J; Stroup W AAPS PharmSciTech; 2018 Feb; 19(2):668-680. PubMed ID: 28948584 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]