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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: mehta m. 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.
Bioavailability and bioequivalence: an FDA regulatory overview.
Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R. Chen ML, et al. Among authors: mehta m. Pharm Res. 2001 Dec;18(12):1645-50. doi: 10.1023/a:1013319408893. Pharm Res. 2001. PMID: 11785681 Review.
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: mehta m. 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: mehta m. 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 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: mehta m. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592
2,507 results