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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: tammara v. 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.
Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.
Malinowski H, Marroum P, Uppoor VR, Gillespie W, Ahn HY, Lockwood P, Henderson J, Baweja R, Hossain M, Fleischer N, Tillman L, Hussain A, Shah V, Dorantes A, Zhu R, Sun H, Kumi K, Machado S, Tammara V, Ong-Chen TE, Mahayni H, Lesko L, Williams R. Malinowski H, et al. Among authors: tammara v. Adv Exp Med Biol. 1997;423:269-88. doi: 10.1007/978-1-4684-6036-0_25. Adv Exp Med Biol. 1997. PMID: 9269503 No abstract available.
A limited sampling approach in bioequivalence studies.
Mahmood I, Chamberlin N, Tammara V. Mahmood I, et al. Among authors: tammara v. Ther Drug Monit. 1997 Aug;19(4):413-9. doi: 10.1097/00007691-199708000-00009. Ther Drug Monit. 1997. PMID: 9263382 Clinical Trial.
12 results