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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: ruegger c. 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.
Examining Manufacturing Readiness for Breakthrough Drug Development.
Dye E, Sturgess A, Maheshwari G, May K, Ruegger C, Ramesh U, Tan H, Cockerill K, Groskoph J, Lacana E, Lee S, Miksinski SP. Dye E, et al. Among authors: ruegger c. AAPS PharmSciTech. 2016 Jun;17(3):529-38. doi: 10.1208/s12249-015-0455-1. Epub 2015 Nov 25. AAPS PharmSciTech. 2016. PMID: 26608693 Review. No abstract available.
64 results