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Challenges and opportunities in implementing the FDA default parametric tolerance interval two one-sided test for delivered dose uniformity of orally inhaled products.
Larner G, Cooper A, Lyapustina S, Leiner S, Christopher D, Strickland H, Golden M, Delzeit HJ, Friedman EM. Larner G, et al. Among authors: christopher d. AAPS PharmSciTech. 2011 Dec;12(4):1144-56. doi: 10.1208/s12249-011-9683-1. Epub 2011 Sep 8. AAPS PharmSciTech. 2011. PMID: 21901649 Free PMC article.
Challenges with developing in vitro dissolution tests for orally inhaled products (OIPs).
Riley T, Christopher D, Arp J, Casazza A, Colombani A, Cooper A, Dey M, Maas J, Mitchell J, Reiners M, Sigari N, Tougas T, Lyapustina S. Riley T, et al. Among authors: christopher d. AAPS PharmSciTech. 2012 Sep;13(3):978-89. doi: 10.1208/s12249-012-9822-3. Epub 2012 Jul 14. AAPS PharmSciTech. 2012. PMID: 22798037 Free PMC article. Review.
Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence.
Christopher D, Adams W, Amann A, Bertha C, Byron PR, Doub W, Dunbar C, Hauck W, Lyapustina S, Mitchell J, Morgan B, Nichols S, Pan Z, Singh GJ, Tougas T, Tsong Y, Wolff R, Wyka B. Christopher D, et al. AAPS PharmSciTech. 2007 Nov 2;8(4):E90. doi: 10.1208/pt0804090. AAPS PharmSciTech. 2007. PMID: 18181550 Free PMC article.
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. Capen R, et al. Among authors: christopher d. AAPS PharmSciTech. 2012 Sep;13(3):911-8. doi: 10.1208/s12249-012-9815-2. Epub 2012 Jun 23. AAPS PharmSciTech. 2012. PMID: 22729779 Free PMC article.
362 results