Sandra Suarez‐Sharp

Simulations Plus (United States) — United States

Pharmacology, Toxicology and Pharmaceutics · Life Sciences

15h-index818citations29works12.62yr avg
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Research Topics

Drug Solubulity and Delivery Systems(16), Protein purification and stability(9), Crystallization and Solubility Studies(9), Analytical Methods in Pharmaceuticals(7), Computational Drug Discovery Methods(6)

Publications29 total

Introducing the Molecular Pharmaceutics Special Issue on the 2023 PBBM Workshop for Drug Product Quality
Molecular Pharmaceutics·2025· 1 cited
Unique Effect of the High-Fat Meal on the Pharmacokinetics of Omaveloxolone Explained by Physiologically Based Biopharmaceutics Modeling
2025
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report
Molecular Pharmaceutics·2024· 17 citedOpen Access
Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling
CPT Pharmacometrics & Systems Pharmacology·2024· 6 citedOpen Access
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
Molecular Pharmaceutics·2024· 26 citedOpen Access
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling
The AAPS Journal·2024· 2 cited
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report
Molecular Pharmaceutics·2024· 49 citedOpen Access
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure
Clinical Pharmacology in Drug Development·2024Open Access
Report on the Virtual Workshop: A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modeling
Dissolution Technologies·2023· 1 citedOpen Access
Virtual Workshop Report: Approaches, Regulatory Challenges, and Advances in Bioequivalence, Dissolution Testing, and Biowaivers: Manila, Philippines, February 22-24, 2023
Dissolution Technologies·2023Open Access
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS
The AAPS Journal·2022· 14 cited
Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation - Workshop Summary Report
Dissolution Technologies·2022· 5 citedOpen Access
Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling
Journal of Pharmaceutical Sciences·2021· 12 citedOpen Access
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies
Journal of Pharmaceutical Sciences·2021· 59 cited
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence
Clinical Pharmacology & Therapeutics·2020· 10 citedOpen Access
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report
Journal of Pharmaceutical Sciences·2020· 53 cited
Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report
Journal of Pharmaceutical Sciences·2020· 30 cited
In Vitro Biopredictive Methods: A Workshop Summary Report
Journal of Pharmaceutical Sciences·2020· 25 cited
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report
The AAPS Journal·2020· 31 cited
Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives
Pharmaceutical Research·2020· 11 cited
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Frequent Co-authors

Xavier Pépin(14), Tycho Heimbach(10), Amitava Mitra(10), Paul Seo(7), Andreas Abend(7), Poonam Delvadia(7), Filippos Kesisoglou(6), Erik Sjögren(5), Evangelos Kotzagiorgis(5), Andrew Babiskin(5), Kimberly Raines(5), Jennifer Dressman(5), Christer Tannergren(5), James E. Polli(5), Xinyuan Zhang(4), Shinichi Kijima(4), Neil Parrott(4), Shereeni Veerasingham(4), Claire Mackie(4), Sumit Arora(4)