Stier EM - Search Results

1

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: stier em. 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.

2

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. 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.

3

Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications.

Williamson LN, Conner DP, Stier EM, Davit BM. Williamson LN, et al. Among authors: stier em. Bioanalysis. 2014 Feb;6(4):441-5. doi: 10.4155/bio.13.329. Bioanalysis. 2014. PMID: 24568348

4

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: stier em. 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.

5

Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications.

Subramaniam S, Stier E, Davit BM. Subramaniam S, et al. Bioanalysis. 2014;6(24):3349-54. doi: 10.4155/bio.14.232. Bioanalysis. 2014. PMID: 25534791 No abstract available.

6

Applications of In Vitro-In Vivo Correlations in Generic Drug Development: Case Studies.

Kaur P, Jiang X, Duan J, Stier E. Kaur P, et al. AAPS J. 2015 Jul;17(4):1035-9. doi: 10.1208/s12248-015-9765-1. Epub 2015 Apr 22. AAPS J. 2015. PMID: 25896303 Free PMC article.

7

Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products.

Kaur P, Jiang X, Stier E. Kaur P, et al. J Pharm Pharm Sci. 2017;20(0):252-257. doi: 10.18433/J39S6Z. J Pharm Pharm Sci. 2017. PMID: 28810949 Free article.

8

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. AAPS J. 2017 Nov;19(6):1593-1599. doi: 10.1208/s12248-017-0137-x. Epub 2017 Sep 6. AAPS J. 2017. PMID: 28879628

9

Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

Mehta MU, Uppoor RS, Conner DP, Seo P, Vaidyanathan J, Volpe DA, Stier E, Chilukuri D, Dorantes A, Ghosh T, Mandula H, Raines K, Dhanormchitphong P, Woodcock J, Yu LX. Mehta MU, et al. Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7. Mol Pharm. 2017. PMID: 29076742

10

Common Deficiencies of in vitro Binding Bioequivalence (BE) Studies Submitted in Abbreviated New Drug Applications (ANDAs).

Lu D, Vivian D, Ren P, Yang Y, Zhang H, Jiang X, Stier E. Lu D, et al. AAPS J. 2018 Jan 11;20(2):26. doi: 10.1208/s12248-017-0182-5. AAPS J. 2018. PMID: 29327295

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