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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: ghosh t. 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.
Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles.
Van Buskirk GA, Arsulowicz D, Basu P, Block L, Cai B, Cleary GW, Ghosh T, González MA, Kanios D, Marques M, Noonan PK, Ocheltree T, Schwarz P, Shah V, Spencer TS, Tavares L, Ulman K, Uppoor R, Yeoh T. Van Buskirk GA, et al. Among authors: ghosh t. AAPS PharmSciTech. 2012 Mar;13(1):218-30. doi: 10.1208/s12249-011-9740-9. Epub 2012 Jan 4. AAPS PharmSciTech. 2012. PMID: 22215291 Free PMC article. Review.
CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products.
Cruz CN, Tyner KM, Velazquez L, Hyams KC, Jacobs A, Shaw AB, Jiang W, Lionberger R, Hinderling P, Kong Y, Brown PC, Ghosh T, Strasinger C, Suarez-Sharp S, Henry D, Van Uitert M, Sadrieh N, Morefield E. Cruz CN, et al. Among authors: ghosh t. AAPS J. 2013 Jul;15(3):623-8. doi: 10.1208/s12248-013-9466-6. Epub 2013 Mar 20. AAPS J. 2013. PMID: 23512727 Free PMC article.
Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.
Yacobi A, Shah VP, Bashaw ED, Benfeldt E, Davit B, Ganes D, Ghosh T, Kanfer I, Kasting GB, Katz L, Lionberger R, Lu GW, Maibach HI, Pershing LK, Rackley RJ, Raw A, Shukla CG, Thakker K, Wagner N, Zovko E, Lane ME. Yacobi A, et al. Among authors: ghosh t. Pharm Res. 2014 Apr;31(4):837-46. doi: 10.1007/s11095-013-1259-1. Epub 2014 Jan 7. Pharm Res. 2014. PMID: 24395404 Review.
Navigating sticky areas in transdermal product development.
Strasinger C, Raney SG, Tran DC, Ghosh P, Newman B, Bashaw ED, Ghosh T, Shukla CG. Strasinger C, et al. Among authors: ghosh p, ghosh t. J Control Release. 2016 Jul 10;233:1-9. doi: 10.1016/j.jconrel.2016.04.032. Epub 2016 Apr 24. J Control Release. 2016. PMID: 27117457 Review.
Drug Dissolution in Oral Drug Absorption: Workshop Report.
Raines K, Agarwal P, Augustijns P, Alayoubi A, Attia L, Bauer-Brandl A, Brandl M, Chatterjee P, Chen H, Yu YC, Coutant C, Coutinho AL, Curran D, Dressman J, Ericksen B, Falade L, Gao Y, Gao Z, Ghosh D, Ghosh T, Govada A, Gray E, Guo R, Hammell D, Hermans A, Jaini R, Li H, Mandula H, Men S, Milsmann J, Moldthan H, Moody R, Moseson DE, Müllertz A, Patel R, Paudel K, Reppas C, Savkur R, Schaefer K, Serajuddin A, Taylor LS, Valapil R, Wei K, Weitschies W, Yamashita S, Polli JE. Raines K, et al. Among authors: ghosh d, ghosh t. AAPS J. 2023 Nov 7;25(6):103. doi: 10.1208/s12248-023-00865-8. AAPS J. 2023. PMID: 37936002
1,167 results