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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: shah vp. 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.
Evaluation of orally administered highly variable drugs and drug formulations.
Shah VP, Yacobi A, Barr WH, Benet LZ, Breimer D, Dobrinska MR, Endrenyi L, Fairweather W, Gillespie W, Gonzalez MA, Hooper J, Jackson A, Lesko LJ, Midha KK, Noonan PK, Patnaik R, Williams RL. Shah VP, et al. Pharm Res. 1996 Nov;13(11):1590-4. doi: 10.1023/a:1016468018478. Pharm Res. 1996. PMID: 8956322 Review. No abstract available.
Draft guidance for industry extended-release solid oral dosage forms.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. 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.
FIP position paper on qualification of paddle and basket dissolution apparatus.
Brown CK, Buhse L, Friedel HD, Keitel S, Kraemer J, Morris JM, Stickelmeyer M, Yomota C, Shah VP; International Pharmaceutical Federation. Brown CK, et al. Among authors: shah vp. AAPS PharmSciTech. 2009;10(3):924-7. doi: 10.1208/s12249-009-9291-5. Epub 2009 Jul 16. AAPS PharmSciTech. 2009. PMID: 19609681 Free PMC article.
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: shah vp. Eur J Pharm Sci. 2010 May 12;40(2):148-53. doi: 10.1016/j.ejps.2010.03.017. Epub 2010 Mar 27. Eur J Pharm Sci. 2010. PMID: 20347972
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, Yu L. Chen ML, et al. Among authors: shah vp. AAPS J. 2010 Sep;12(3):371-7. doi: 10.1208/s12248-010-9201-5. Epub 2010 May 4. AAPS J. 2010. PMID: 20440588 Free PMC article.
Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume H, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX. Chen ML, et al. Among authors: shah vp. AAPS J. 2011 Dec;13(4):556-64. doi: 10.1208/s12248-011-9294-5. Epub 2011 Aug 16. AAPS J. 2011. PMID: 21845486 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: shah vp. 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.
282 results