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Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.
Stier EM, Davit BM, Chandaroy P, Chen ML, Fourie-Zirkelbach J, Jackson A, Kim S, Lionberger R, Mehta M, Uppoor RS, Wang Y, Yu L, Conner DP. Stier EM, et al. Among authors: conner dp. AAPS J. 2012 Dec;14(4):925-6. doi: 10.1208/s12248-012-9397-7. Epub 2012 Sep 14. AAPS J. 2012. PMID: 22976173 Free PMC article. No abstract available.
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. 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.
Dissolution testing for generic drugs: an FDA perspective.
Anand O, Yu LX, Conner DP, Davit BM. Anand O, et al. Among authors: conner dp. AAPS J. 2011 Sep;13(3):328-35. doi: 10.1208/s12248-011-9272-y. Epub 2011 Apr 9. AAPS J. 2011. PMID: 21479700 Free PMC article.
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.
Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwakama PE, Patel DT, Schuirmann DJ, Yu LX. Davit BM, et al. Among authors: conner dp. AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13. AAPS J. 2012. PMID: 22972221 Free PMC article. Review.
61 results