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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. 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.
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. 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 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. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592
Bioequivalence approaches for highly variable drugs and drug products.
Haidar SH, Davit B, Chen ML, Conner D, Lee L, Li QH, Lionberger R, Makhlouf F, Patel D, Schuirmann DJ, Yu LX. Haidar SH, et al. Among authors: chen ml. Pharm Res. 2008 Jan;25(1):237-41. doi: 10.1007/s11095-007-9434-x. Epub 2007 Sep 22. Pharm Res. 2008. PMID: 17891552 Review.
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