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The AAPS Journal|October 26, 2020
Science and Risked-Based Stability Testing Strategies-a Test Case on the Global Implementation and Regulatory ReceptionDorys Argelia Diaz, Michael Lynch, Megan McMahon, et al.The AAPS Journal|November 6, 2019
Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage FormsConnie Langer, Dorys Argelia Diaz, Leslie Van Alstine, et al.Journal of Pharmaceutical Sciences|August 23, 2024
Industry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug productsAndreas Abend, Diana Sperger, Dorys Argelia Diaz, et al.The AAPS Journal|May 21, 2020
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary ReportSandra Suarez-Sharp, Andreas Abend, Thomas Hoffelder, et al.The AAPS Journal|October 3, 2015
Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?Dorys Argelia Diaz, Stephen T Colgan, Connie S Langer, et al.The AAPS Journal|April 21, 2023
Dissolution Profile Similarity Assessment-Best Practices, Decision Trees and Global HarmonizationAndreas M Abend, Thomas Hoffelder, Michael J Cohen, et al.The AAPS Journal|April 7, 2022
DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONSThomas Hoffelder, David Leblond, Leslie Van Alstine, et al.Pageof 1