Chen ML - Search Results

1

The use of drug metabolism for prediction of intestinal permeability (dagger).

Chen ML, Yu L. Chen ML, et al. Mol Pharm. 2009 Jan-Feb;6(1):74-81. doi: 10.1021/mp8001864. Mol Pharm. 2009. PMID: 19132929

2

The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.

Chen ML, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, Schug B, Tsang YC, Wedemeyer RS, Weitschies W, Welink J. Chen ML, et al. Eur J Pharm Sci. 2018 Jan 1;111:153-157. doi: 10.1016/j.ejps.2017.09.047. Epub 2017 Sep 28. Eur J Pharm Sci. 2018. PMID: 28964950 Review.

3

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.

4

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

5

Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products.

Raney SG, Franz TJ, Lehman PA, Lionberger R, Chen ML. Raney SG, et al. Among authors: chen ml. Clin Pharmacokinet. 2015 Nov;54(11):1095-106. doi: 10.1007/s40262-015-0292-0. Clin Pharmacokinet. 2015. PMID: 26063051 Review.

6

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: chen ml. 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.

7

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

8

Equivalence-by-design: targeting in vivo drug delivery profile.

Chen ML, Lee VH. Chen ML, et al. Pharm Res. 2008 Dec;25(12):2723-30. doi: 10.1007/s11095-008-9743-8. Epub 2008 Oct 28. Pharm Res. 2008. PMID: 18956142

9

Lipid excipients and delivery systems for pharmaceutical development: a regulatory perspective.

Chen ML. Chen ML. Adv Drug Deliv Rev. 2008 Mar 17;60(6):768-77. doi: 10.1016/j.addr.2007.09.010. Epub 2007 Nov 12. Adv Drug Deliv Rev. 2008. PMID: 18077051 Review.

10

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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