Patient-Centric Drug Product Quality Specifications: a Convergence of Clinical and Nonclinical Considerations - Stan Altan; Hans Coppenolle; Trine Kvist; Katharina Reckermann; Sandra Suarez-Sharp; Timothy Schofield (The AAPS Journal, 2025)

Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling - Xavier J. H. Pepin; Sandra Suarez-Sharp (The AAPS Journal, 2024)

DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS - Thomas Hoffelder; David Leblond; Leslie Van Alstine; Dorys Argelia Diaz; Sandra Suarez-Sharp; Krista Witkowski; Stan Altan; James Reynolds; Zachary Bergeron; Kevin Lief; Yanbing Zheng; Andreas Abend (The AAPS Journal, 2022)

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations - Andreas M. Abend; Limin Zhang; Emilija Fredro-Kumbaradzi; Thomas Hoffelder; Michael J. Cohen; Om Anand; Poonam Delvadia; Haritha Mandula; Zhen Zhang; Evangelos Kotzagiorgis; Susan Lum; Victor Gomes Pereira; et al. (The AAPS Journal, 2022)

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; Elisabeth Kovacs; Dorys Argelia Diaz (The AAPS Journal, 2020)

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; Siladitya Ray Chaudhuri; Bart Hens (Pharmaceutical Research, 2020)

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; Xavier Pepin; Erik Sjögren; Eleftheria Tsakalozou; Paul Seo; Min Li; Xinyuan Zhang; Ho-Pi Lin; et al. (The AAPS Journal, 2019)

Dissolution Testing in Drug Product Development: Workshop Summary Report - Andreas Abend; David Curran; Jesse Kuiper; Xujin Lu; Hanlin Li; Andre Hermans; Pramod Kotwal; Dorys A. Diaz; Michael J. Cohen; Limin Zhang; Erika Stippler; German Drazer; et al. (The AAPS Journal, 2019)

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report - Sandra Suarez-Sharp; Michael Cohen; Filippos Kesisoglou; Andreas Abend; Patrick Marroum; Poonam Delvadia; Evangelos Kotzagiorgis; Min Li; Anna Nordmark; Nagesh Bandi; Erik Sjögren; Andrew Babiskin; et al. (The AAPS Journal, 2018)

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 (The AAPS Journal, 2018)

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications - Sandra Suarez-Sharp; Min Li; John Duan; Heta Shah; Paul Seo (The AAPS Journal, 2016)

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications - Sandra Suarez-Sharp; Poonam R. Delvadia; Angelica Dorantes; John Duan; Anna Externbrink; Zongming Gao; Tapash Ghosh; Sarah Pope Miksinski; Paul Seo (The AAPS Journal, 2016)

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products - Celia N. Cruz; Katherine M. Tyner; Lydia Velazquez; Kenneth C. Hyams; Abigail Jacobs; Arthur B. Shaw; Wenlei Jiang; Robert Lionberger; Peter Hinderling; Yoon Kong; Paul C. Brown; Tapash Ghosh; et al. (The AAPS Journal, 2013)