Publications by authors named "Sandra Suarez Sharp"

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Patient-Centric Drug Product Quality Specifications: a Convergence of Clinical and Nonclinical Considerations.
Stan Altan, Hans Coppenolle, Trine Kvist, Katharina Reckermann, Sandra Suarez-Sharp

AAPS J· October 2025

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Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: a webinar summary.
Lanyan Fang, Shereeni Veerasingham, Yunming Xu, Alfredo Garcia-Arieta, Sivacharan Kollipara, Sandra Suarez-Sharp

J Pharm Sci· October 2025

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Introducing the Molecular Pharmaceutics Special Issue on the 2023 PBBM Workshop for Drug Product Quality.
Claire Mackie, Xavier Pepin, Tycho Heimbach, Christer Tannergren, Sumit Arora, Sandra Suarez-Sharp

Mol Pharm· June 2025

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Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
Christer Tannergren, Sumit Arora, Andrew Babiskin, Luiza Borges, Parnali Chatterjee, Sandra Suarez-Sharp

Mol Pharm· January 2025

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The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based Pharmacokinetic Modeling (PBBM) and Risk Assessment.
Xavier J H Pepin, Juliana Johansson Soares Medeiros, Livia Deris Prado, Sandra Suarez Sharp

Pharmaceutics· December 2024

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Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling.
Xavier J H Pepin, Scott M Hynes, Hamim Zahir, Deborah Walker, Lois Q Semmens, Sandra Suarez-Sharp

CPT Pharmacometrics Syst Pharmacol· October 2024

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Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Xavier Pepin, Sumit Arora, Luiza Borges, Mario Cano-Vega, Tessa Carducci, Sandra Suarez-Sharp

Mol Pharm· August 2024

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Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Claire Mackie, Sumit Arora, Paul Seo, Rebecca Moody, Bhagwant Rege, Sandra Suarez-Sharp

Mol Pharm· May 2024

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Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure.
Shintaro Nakayama, Viera Lukacova, Shuichi Tanabe, Akiko Watanabe, Jim Mullin, Sandra Suarez-Sharp

Clin Pharmacol Drug Dev· April 2024

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Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling.
Xavier J H Pepin, Sandra Suarez-Sharp

AAPS J· April 2024

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DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.
Thomas Hoffelder, David Leblond, Leslie Van Alstine, Dorys Argelia Diaz, Sandra Suarez-Sharp

AAPS J· April 2022

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Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling.
Mauricio A García, Michael B Bolger, Sandra Suarez-Sharp, Peter Langguth

J Pharm Sci· January 2022

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Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.
Tycho Heimbach, Filippos Kesisoglou, Jasmina Novakovic, Christophe Tistaert, Martin Mueller-Zsigmondy, Sandra Suarez-Sharp

J Pharm Sci· December 2021

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Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
Jieon Lee, Yuqing Gong, Sid Bhoopathy, Charles E DiLiberti, Andrew C Hooker, Sandra Suarez-Sharp

Clin Pharmacol Ther· November 2021

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Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.
Xavier J H Pepin, Neil Parrott, Jennifer Dressman, Poonam Delvadia, Amitava Mitra, Sandra Suarez-Sharp

J Pharm Sci· February 2021

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In Vitro Biopredictive Methods: A Workshop Summary Report.
Xavier J H Pepin, Jennifer Dressman, Neil Parrott, Poonam Delvadia, Amitava Mitra, Sandra Suarez-Sharp

J Pharm Sci· February 2021

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Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
Neil Parrott, Sandra Suarez-Sharp, Filippos Kesisoglou, Shriram M Pathak, David Good

J Pharm Sci· February 2021

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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Amitava Mitra, Sandra Suarez-Sharp, Xavier J H Pepin, Talia Flanagan, Yang Zhao

J Pharm Sci· February 2021

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Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives.
Sandra Suarez-Sharp, Anders Lindahl, Tycho Heimbach, Amin Rostami-Hodjegan, Michael B Bolger

Pharm Res· May 2020

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In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report.
Sandra Suarez-Sharp, Andreas Abend, Thomas Hoffelder, David Leblond, Poonam Delvadia

AAPS J· May 2020

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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.
Tycho Heimbach, Sandra Suarez-Sharp, Maziar Kakhi, Nico Holmstock, Andrés Olivares-Morales

AAPS J· February 2019

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Dissolution Testing in Drug Product Development: Workshop Summary Report.
Andreas Abend, David Curran, Jesse Kuiper, Xujin Lu, Hanlin Li, Sandra Suarez-Sharp

AAPS J· January 2019

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Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
Sandra Suarez-Sharp, Michael Cohen, Filippos Kesisoglou, Andreas Abend, Patrick Marroum

AAPS J· August 2018

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Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.
Andreas Abend, Tycho Heimbach, Michael Cohen, Filippos Kesisoglou, Xavier Pepin, Sandra Suarez-Sharp

AAPS J· April 2018

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Application of an NLME-Stochastic Deconvolution Approach to Level A IVIVC Modeling.
Maziar Kakhi, Sandra Suarez-Sharp, Terry Shepard, Jason Chittenden

J Pharm Sci· July 2017

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