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The Goldilocks Challenge-Controlling Uncertainty When Setting Product Specifications.

Burdick RK, O'Neill JC. Burdick RK, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):439-445. doi: 10.5731/pdajpst.2019.010850. Epub 2020 Mar 16. PDA J Pharm Sci Technol. 2020. PMID: 32179710

Statistical considerations in setting product specifications.

Dong X, Tsong Y, Shen M. Dong X, et al. J Biopharm Stat. 2015;25(2):280-94. doi: 10.1080/10543406.2014.972511. J Biopharm Stat. 2015. PMID: 25358110 Review.

Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products.

Ruesch MN, Benetti L, Berkay E, Cirelli DJ, Frantz N, Gastens MH, Kelley WP, Kretsinger J, Lewis M, Novick S, Rellahan B, Pack L, Stroop CJM, Subashi A, Yin P, Zeng M, Stults J. Ruesch MN, et al. J Pharm Sci. 2021 Feb;110(2):771-784. doi: 10.1016/j.xphs.2020.09.048. Epub 2020 Oct 7. J Pharm Sci. 2021. PMID: 33035537 Free article.

Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling.

Yang H. Yang H. PDA J Pharm Sci Technol. 2013 Sep-Oct;67(5):533-43. doi: 10.5731/pdajpst.2013.00935. PDA J Pharm Sci Technol. 2013. PMID: 24084662

FDA perspective on specifications for biotechnology products--from IND to PLA.

Murano G. Murano G. Dev Biol Stand. 1997;91:3-13. Dev Biol Stand. 1997. PMID: 9413677 Review.

Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade^®.

Melsheimer R, Calmann M, DeRitis A, Philip V, Van Gog F, Doolittle L, Goyal K, Neblock D. Melsheimer R, et al. BioDrugs. 2018 Oct;32(5):405-414. doi: 10.1007/s40259-018-0300-7. BioDrugs. 2018. PMID: 30143982 Free PMC article. Review.

Risk analysis of sterile production plants: a new and simple, workable approach.

Gapp G, Holzknecht P. Gapp G, et al. PDA J Pharm Sci Technol. 2011 May-Jun;65(3):217-26. doi: 10.5731/pdajpst.2011.00693. PDA J Pharm Sci Technol. 2011. PMID: 22293233

Points to consider when establishing drug product specifications for parenteral microspheres.

Kumar R, Palmieri MJ Jr. Kumar R, et al. AAPS J. 2010 Mar;12(1):27-32. doi: 10.1208/s12248-009-9156-6. Epub 2009 Nov 17. AAPS J. 2010. PMID: 19921439 Free PMC article. Review.

Quality risk management in pharmaceutical development.

Charoo NA, Ali AA. Charoo NA, et al. Drug Dev Ind Pharm. 2013 Jul;39(7):947-60. doi: 10.3109/03639045.2012.699065. Epub 2012 Jul 3. Drug Dev Ind Pharm. 2013. PMID: 22757979 Review.

Interpretation and optimization of the dissolution specifications for a modified release product with an in vivo-in vitro correlation (IVIVC).

Hayes S, Dunne A, Smart T, Davis J. Hayes S, et al. J Pharm Sci. 2004 Mar;93(3):571-81. doi: 10.1002/jps.10552. J Pharm Sci. 2004. PMID: 14762896

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