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Journal of Pharmaceutical Sciences|February 10, 2015
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: LevetiracetamMarija Petruševska, Sandra Berglez, Igor Krisch, et al.Journal of Pharmaceutical Sciences|September 24, 2016
Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring GridPaul A Dickinson, Filippos Kesisoglou, Talia Flanagan, et al.Clinical Pharmacology and Therapeutics|October 17, 2022
Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop SummarySophie Shubow, Qin Sun, Ai Len Nguyen Phan, et al.Journal of Pharmaceutical Sciences|October 1, 2021
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate MonohydrateNaseem A Charoo, Daud B Abdallah, Ahmed Abdalla Bakheit, et al.Journal of Pharmaceutical Sciences|November 27, 2025
Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine besylatePorfirio de la Cruz-Cruz, Mauricio A García, José Trinidad Pérez-Urizar, et al.Molecular Pharmaceutics|April 11, 2024
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary ReportClaire Mackie, Sumit Arora, Paul Seo, et al.Molecular Pharmaceutics|January 25, 2019
Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric ApproachHeather M Neu, Sergei A Alexishin, Joel E P Brandis, et al.Journal of Pharmaceutical Sciences|August 27, 2017
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic AcidMartin A Hofsäss, Jacqueline de Souza, Neila M Silva-Barcellos, et al.Journal of Pharmaceutical Sciences|September 27, 2014
The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performanceArzu Selen, Paul A Dickinson, Anette Müllertz, et al.The AAPS Journal|June 12, 2012
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalenceJames E Polli, Jack A Cook, Barbara M Davit, et al.Pageof 18