Davit B - Search Results

1

Novel bioequivalence approach for narrow therapeutic index drugs.

Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Among authors: davit b. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762

2

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: davit b. 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.

3

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

Haidar SH, Makhlouf F, Schuirmann DJ, Hyslop T, Davit B, Conner D, Yu LX. Haidar SH, et al. Among authors: davit b. AAPS J. 2008 Sep;10(3):450-4. doi: 10.1208/s12248-008-9053-4. Epub 2008 Aug 26. AAPS J. 2008. PMID: 18726698 Free PMC article.

4

Using partial area for evaluation of bioavailability and bioequivalence.

Chen ML, Davit B, Lionberger R, Wahba Z, Ahn HY, Yu LX. Chen ML, et al. Among authors: davit b. Pharm Res. 2011 Aug;28(8):1939-47. doi: 10.1007/s11095-011-0421-x. Epub 2011 Apr 13. Pharm Res. 2011. PMID: 21487930 Review.

5

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J. Davit BM, et al. Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23. Ann Pharmacother. 2009. PMID: 19776300

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. 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

Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.

Kaur P, Chaurasia CS, Davit BM, Conner DP. Kaur P, et al. J Clin Pharmacol. 2013 Dec;53(12):1252-60. doi: 10.1002/jcph.163. Epub 2013 Sep 21. J Clin Pharmacol. 2013. PMID: 23996908

8

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: davit b. Clin Ther. 2010 Sep;32(10):1704-12. doi: 10.1016/j.clinthera.2010.09.014. Clin Ther. 2010. PMID: 21194592

9

Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications.

Davit BM, Conner DP, Fabian-Fritsch B, Haidar SH, Jiang X, Patel DT, Seo PR, Suh K, Thompson CL, Yu LX. Davit BM, et al. AAPS J. 2008;10(1):148-56. doi: 10.1208/s12248-008-9015-x. Epub 2008 Mar 5. AAPS J. 2008. PMID: 18446515 Free PMC article.

10

Utility of physiologically based absorption modeling in implementing Quality by Design in drug development.

Zhang X, Lionberger RA, Davit BM, Yu LX. Zhang X, et al. AAPS J. 2011 Mar;13(1):59-71. doi: 10.1208/s12248-010-9250-9. Epub 2011 Jan 5. AAPS J. 2011. PMID: 21207216 Free PMC article.

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