Conner DP - Search Results

1

In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.

Ren P, Cui M, Anand O, Xia L, Zhao ZJ, Sun D, Sharp T, Conner DP, Peters J, Jiang W, Stier E, Jiang X. Ren P, et al. Among authors: conner dp. AAPS J. 2017 Nov;19(6):1593-1599. doi: 10.1208/s12248-017-0137-x. Epub 2017 Sep 6. AAPS J. 2017. PMID: 28879628

2

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, Yu LX, Lionberger R. Jiang W, et al. AAPS J. 2015 Jul;17(4):891-901. doi: 10.1208/s12248-015-9753-5. Epub 2015 Apr 4. AAPS J. 2015. PMID: 25840883 Free PMC article.

3

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. Among authors: conner dp. 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.

4

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.

5

Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.

Nair AK, Anand O, Chun N, Conner DP, Mehta MU, Nhu DT, Polli JE, Yu LX, Davit BM. Nair AK, et al. Among authors: conner dp. AAPS J. 2012 Dec;14(4):664-6. doi: 10.1208/s12248-012-9384-z. Epub 2012 Jun 21. AAPS J. 2012. PMID: 22718306 Free PMC article.

6

Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.

Li BV, Davit BM, Lee CH, Pabba SK, Mahadevan C, Caramenico HT, Haidar SH, Sanchez AL, Sigler AW, Stier EM, Conner DP. Li BV, et al. Among authors: conner dp. AAPS J. 2013 Jan;15(1):10-4. doi: 10.1208/s12248-012-9415-9. Epub 2012 Sep 28. AAPS J. 2013. PMID: 23054974 Free PMC article.

7

Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

Braddy AC, Davit BM, Stier EM, Conner DP. Braddy AC, et al. Among authors: conner dp. AAPS J. 2015 Jan;17(1):121-33. doi: 10.1208/s12248-014-9679-3. Epub 2014 Oct 25. AAPS J. 2015. PMID: 25344440 Free PMC article. Review.

8

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences.

Lu D, Lee SL, Lionberger RA, Choi S, Adams W, Caramenico HN, Chowdhury BA, Conner DP, Katial R, Limb S, Peters JR, Yu L, Seymour S, Li BV. Lu D, et al. Among authors: conner dp. AAPS J. 2015 May;17(3):546-57. doi: 10.1208/s12248-015-9733-9. Epub 2015 Mar 11. AAPS J. 2015. PMID: 25758352 Free PMC article. Review.

9

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, Yu LX, Lionberger R. Jiang W, et al. AAPS J. 2015 Nov;17(6):1519. doi: 10.1208/s12248-015-9786-9. AAPS J. 2015. PMID: 25975618 Free PMC article. No abstract available.

10

Generic drugs--safe, effective, and affordable.

Peters JR, Hixon DR, Conner DP, Davit BM, Catterson DM, Parise CM. Peters JR, et al. Among authors: conner dp. Dermatol Ther. 2009 May-Jun;22(3):229-40. doi: 10.1111/j.1529-8019.2009.01236.x. Dermatol Ther. 2009. PMID: 19453347 Review.

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