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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.
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. Eur J Pharm Sci. 2011 Nov 20;44(4):506-13. doi: 10.1016/j.ejps.2011.09.010. Epub 2011 Sep 16. Eur J Pharm Sci. 2011. PMID: 21946259
Developing and advancing dry powder inhalation towards enhanced therapeutics.
Stegemann S, Kopp S, Borchard G, Shah VP, Senel S, Dubey R, Urbanetz N, Cittero M, Schoubben A, Hippchen C, Cade D, Fuglsang A, Morais J, Borgström L, Farshi F, Seyfang KH, Hermann R, van de Putte A, Klebovich I, Hincal A. Stegemann S, et al. Among authors: shah vp. Eur J Pharm Sci. 2013 Jan 23;48(1-2):181-94. doi: 10.1016/j.ejps.2012.10.021. Epub 2012 Nov 7. Eur J Pharm Sci. 2013. PMID: 23142635 Review.
The similarity question for biologicals and non-biological complex drugs.
Crommelin DJ, Shah VP, Klebovich I, McNeil SE, Weinstein V, Flühmann B, Mühlebach S, de Vlieger JS. Crommelin DJ, et al. Among authors: shah vp. Eur J Pharm Sci. 2015 Aug 30;76:10-7. doi: 10.1016/j.ejps.2015.04.010. Epub 2015 Apr 23. Eur J Pharm Sci. 2015. PMID: 25912826 Free 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
282 results