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Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.
Van Buskirk GA, Asotra S, Balducci C, Basu P, DiDonato G, Dorantes A, Eickhoff WM, Ghosh T, González MA, Henry T, Howard M, Kamm J, Laurenz S, MacKenzie R, Mannion R, Noonan PK, Ocheltree T, Pai U, Poska RP, Putnam ML, Raghavan RR, Ruegger C, Sánchez E, Shah VP, Shao ZJ, Somma R, Tammara V, Thombre AG, Thompson B, Timko RJ, Upadrashta S, Vaithiyalingam S; Manufacturing Technical Committee of the Product Quality Research Institute. Van Buskirk GA, et al. Among authors: vaithiyalingam s. AAPS PharmSciTech. 2014 Jun;15(3):665-93. doi: 10.1208/s12249-014-0087-x. Epub 2014 Mar 1. AAPS PharmSciTech. 2014. PMID: 24578237 Free PMC article. Review.
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu LX, Baker J, Berlam SC, Boam A, Brandreth EJ, Buhse L, Cosgrove T, Doleski D, Ensor L, Famulare J, Ganapathy M, Grampp G, Hussong D, Iser R, Johnston G, Kesisoglou F, Khan M, Kozlowski S, Lacana E, Lee SL, Miller S, Miksinski SP, Moore CM, Mullin T, Raju GK, Raw A, Rosencrance S, Rosolowsky M, Stinavage P, Thomas H, Wesdyk R, Windisch J, Vaithiyalingam S. Yu LX, et al. Among authors: vaithiyalingam s. AAPS J. 2015 Jul;17(4):1011-8. doi: 10.1208/s12248-015-9754-4. Epub 2015 Apr 4. AAPS J. 2015. PMID: 25840884 Free PMC article.
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