Davit BM - Search Results

1

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.

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. 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. 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

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.

5

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. 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.

6

International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

Davit B, Braddy AC, Conner DP, Yu LX. Davit B, et al. AAPS J. 2013 Oct;15(4):974-90. doi: 10.1208/s12248-013-9499-x. Epub 2013 Jul 3. AAPS J. 2013. PMID: 23821352 Free PMC article. Review.

7

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.

8

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

9

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. Among authors: davit bm. 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.

10

Dissolution testing for generic drugs: an FDA perspective.

Anand O, Yu LX, Conner DP, Davit BM. Anand O, et al. Among authors: davit bm. 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.

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