L. Pavčnik, M. Prunk, T. Trdan Lušin, and R. Roškar
“Accelerated Predictive Stability Testing: Accelerating Registration Phase and Application of Reduced Designs for Shelf-Life Determination of Parenteral Drug Product”
MDPI: Pharmaceutics, Volume 17, Issue 2
January 2025
D. Modhave, S. Vrielynck, and K. Roeleveld
“Assessing Drug Product Shelf Life Using the Accelerated Stability Assessment Program: A Case Study of a GLPG4399 Capsule Formulation”
National Library of Medicine
November 2024
V. Rakers, J. Wang, and D. Kou
“Accelerated Predictive Stability study of a Pediatric Drug Product for a Supplemental New Drug Application”
AAPS PharmSciTech
June 2024
M. Fu, A. Orta, R. Bujalski, J. Greene, L. Pranatharthiharan, and B.Wei
“Development, Comparison, and Qualification of Predictive Pharmaceutical Stability Models Using Independent Statistical Tools”
Journal of Pharmaceutical Innovation
May 2024
L. Dai, J. Davis, K. Nagapudi, P. Mantik, K. Zhang, J. Pellett, and B. Wei
“Predicting Long-Term Stability of an Oral Delivered Antibody Drug Product with Accelerated Stability Assessment Program Modeling”
Molecular Pharmaceutics
December 2023
D. Kumar Singh and S. Singh
“Drug Substance/Product Quality Analysis (Quality Assessment)”
The Quintessence of Basic and Clinical Research and Scientific Publishing
October 2023
J. Fine, P. Wijewardhane, S. Dawood Beer Mohideen, K. Smith, J. Bothe, Y. Krishnamachari, A. Andrews, Y. Liu, and G. Chopra
“Learning Relationships Between Chemical and Physical Stability for Peptide Drug Development”
Pharmaceutical Research
March 2023
E. de Pablo, P. O’Connell, R. Fernández-García, S. Marchand, A. Chauzy, F. Tewes, M. Dea-Ayuela, D. Kumar, F. Bolás, M. Ballesteros, J. Torrado, A. Healy, and D. Serrano
“Targeting lung macrophages for fungal and parasitic pulmonary infections with innovative amphotericin B dry powder inhalers”
International Journal of Pharmaceutics
March 2023
P. Legrand, S. Dufaÿ, N. Mignet, P. Houzé, and R. Gahoual
“Modeling study of long-term stability of the monoclonal antibody infliximab and biosimilars using liquid-chromatography-tandem mass spectrometry and size-exclusion chromatography-multi-angle light scattering“
Analytical and Bioanalytical Chemistry
January 2023
N. Zhao
“Discussion on the Technical Requirements and Methods for In-use Stability Testing of Drug Products”
Chinese Journal of Clinical Pharmacology
National Drug Administration, Drug Evaluation Center, Beijing, China
January 2022
S. Buchanan and S. Konagurthu
“Accelerated stability assessment for an oral N-type calcium channel blocker”
Thermo Fisher Scientific
Presented at AAPS PharmSci 360, October-November 2020
H. Forcinio
“Modeling Streamlines Package Stability Testing”
PharmTech: Equipment and Processing Report: Volume 13, Issue 8
July 2020
M. McMahon, et al.
“Utilization of risk-based predictive stability within regulatory submissions; industry’s experience”
SpringerOpen: AAPS Open
May 2020
F. Bidet
“Rethinking Dry Powder Inhaler Packaging: New Solutions to Old Challenges”
Aptar CSP Technologies
Presented at Pharmapack EU, Paris, France, February 2020