Stier E - 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: stier e. 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

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 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. 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.

4

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

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

5

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. 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.

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. Among authors: stier e. 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. Among authors: stier e. J Pharm Pharm Sci. 2017;20(0):252-257. doi: 10.18433/J39S6Z. J Pharm Pharm Sci. 2017. PMID: 28810949 Free article.

8

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. Among authors: stier e. Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7. Mol Pharm. 2017. PMID: 29076742

9

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. Among authors: stier e. AAPS J. 2018 Jan 11;20(2):26. doi: 10.1208/s12248-017-0182-5. AAPS J. 2018. PMID: 29327295

10

Bioequivalence Study Methods with Pharmacokinetic Endpoints for Topical Ophthalmic Corticosteroid Suspensions and Effects of Subject Demographics.

Harigaya Y, Jiang X, Zhang H, Chandaroy P, Stier EM, Pan Y. Harigaya Y, et al. Pharm Res. 2018 Nov 15;36(1):13. doi: 10.1007/s11095-018-2537-8. Pharm Res. 2018. PMID: 30443681

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