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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: ganes d. 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.
Challenges and opportunities in establishing scientific and regulatory standards for determining 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: ganes d. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592
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: ganes d. 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.
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: ganes d. 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
Stepwise determination of multicompartment disposition and absorption parameters from extravascular concentration-time data. Application to mesoridazine, flurbiprofen, flunarizine, labetalol, and diazepam.
Wagner JG, Ganes DA, Midha KK, Gonzalez-Younes I, Sackellares JC, Olson LD, Affrime MB, Patrick JE. Wagner JG, et al. Among authors: ganes da. J Pharmacokinet Biopharm. 1991 Aug;19(4):413-55. doi: 10.1007/BF01061665. J Pharmacokinet Biopharm. 1991. PMID: 1920088 Free article.
17 results