Suarez-Sharp S - Search Results

1

In Vitro Biopredictive Methods: A Workshop Summary Report.

Pepin XJH, Dressman J, Parrott N, Delvadia P, Mitra A, Zhang X, Babiskin A, Kolhatkar V, Seo P, Taylor LS, Sjögren E, Butler JM, Kostewicz E, Tannergren C, Koziolek M, Kesisoglou F, Dallmann A, Zhao Y, Suarez-Sharp S. Pepin XJH, et al. J Pharm Sci. 2021 Feb;110(2):567-583. doi: 10.1016/j.xphs.2020.09.021. Epub 2020 Sep 19. J Pharm Sci. 2021. PMID: 32956678

2

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.

Abend A, Heimbach T, Cohen M, Kesisoglou F, Pepin X, Suarez-Sharp S. Abend A, et al. AAPS J. 2018 Apr 9;20(3):60. doi: 10.1208/s12248-018-0213-x. AAPS J. 2018. PMID: 29633092

3

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.

Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X. Suarez-Sharp S, et al. AAPS J. 2018 Aug 27;20(6):93. doi: 10.1208/s12248-018-0252-3. AAPS J. 2018. PMID: 30151612

4

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.

Heimbach T, Suarez-Sharp S, Kakhi M, Holmstock N, Olivares-Morales A, Pepin X, Sjögren E, Tsakalozou E, Seo P, Li M, Zhang X, Lin HP, Montague T, Mitra A, Morris D, Patel N, Kesisoglou F. Heimbach T, et al. AAPS J. 2019 Feb 11;21(2):29. doi: 10.1208/s12248-019-0298-x. AAPS J. 2019. PMID: 30746576

5

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.

Pepin XJH, Parrott N, Dressman J, Delvadia P, Mitra A, Zhang X, Babiskin A, Kolhatkar V, Suarez-Sharp S. Pepin XJH, et al. J Pharm Sci. 2021 Feb;110(2):555-566. doi: 10.1016/j.xphs.2020.04.021. Epub 2020 May 4. J Pharm Sci. 2021. PMID: 32380182

6

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.

Parrott N, Suarez-Sharp S, Kesisoglou F, Pathak SM, Good D, Wagner C, Dallmann A, Mullin J, Patel N, Riedmaier AE, Mitra A, Raines K, Butler J, Kakhi M, Li M, Zhao Y, Tsakalozou E, Flanagan T, Dressman J, Pepin X. Parrott N, et al. J Pharm Sci. 2021 Feb;110(2):584-593. doi: 10.1016/j.xphs.2020.09.058. Epub 2020 Oct 13. J Pharm Sci. 2021. PMID: 33058891

7

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.

Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A. Mitra A, et al. J Pharm Sci. 2021 Feb;110(2):594-609. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3. J Pharm Sci. 2021. PMID: 33152375

8

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.

Heimbach T, Kesisoglou F, Novakovic J, Tistaert C, Mueller-Zsigmondy M, Kollipara S, Ahmed T, Mitra A, Suarez-Sharp S. Heimbach T, et al. Among authors: suarez sharp s. J Pharm Sci. 2021 Dec;110(12):3896-3906. doi: 10.1016/j.xphs.2021.09.017. Epub 2021 Sep 20. J Pharm Sci. 2021. PMID: 34551349

9

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report.

Suarez-Sharp S, Abend A, Hoffelder T, Leblond D, Delvadia P, Kovacs E, Diaz DA. Suarez-Sharp S, et al. AAPS J. 2020 May 19;22(4):74. doi: 10.1208/s12248-020-00458-9. AAPS J. 2020. PMID: 32430592 Review.

10

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications.

Suarez-Sharp S, Delvadia PR, Dorantes A, Duan J, Externbrink A, Gao Z, Ghosh T, Miksinski SP, Seo P. Suarez-Sharp S, et al. AAPS J. 2016 May;18(3):578-88. doi: 10.1208/s12248-016-9893-2. Epub 2016 Feb 29. AAPS J. 2016. PMID: 26928450 Free PMC article. Review.

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