Abstract

Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mechanisms of degradation. These modeling tools provide stability insights within weeks that could take months or years to understand using long-term stability conditions only. Despite their usefulness, the knowledge gained through these tools are not as broadly used to support regulatory filing strategies. This paper aims to communicate how industry has used RBPS data to support regulatory submissions and discuss the regulatory feedback that was received.

Details

Title
Utilization of risk-based predictive stability within regulatory submissions; industry’s experience
Author
McMahon, Megan 1   VIAFID ORCID Logo  ; Williams, Helen 2 ; Debie Elke 3 ; Fu Mingkun 4 ; Bujalski, Robert 4 ; Qiu Fenghe 5 ; Wu, Yan 6 ; Hanlin, Li 7 ; Wang, Jin 8 ; Hoaglund-Hyzer Cherokee 9 ; Pulliam Donnie 10 

1  Pfizer Inc., Groton, USA (GRID:grid.410513.2) (ISNI:0000 0000 8800 7493) 
2  AstraZeneca, Cheshire, UK (GRID:grid.417815.e) (ISNI:0000 0004 5929 4381) 
3  Janssen Pharmaceutica R&D, a Division of Janssen Pharmaceutica NV, Beerse, Belgium (GRID:grid.419619.2) (ISNI:0000 0004 0623 0341) 
4  Sunovion Pharmaceuticals, Marlborough, USA (GRID:grid.419756.8) 
5  Boehringer Ingelheim, Ridgefield, USA (GRID:grid.418412.a) (ISNI:0000 0001 1312 9717) 
6  Merck & Co., Inc., Kenilworth, USA (GRID:grid.417993.1) (ISNI:0000 0001 2260 0793) 
7  Vertex Pharmaceuticals, Boston, USA (GRID:grid.422219.e) (ISNI:0000 0004 0384 7506) 
8  Genentech, South San Francisco, USA (GRID:grid.418158.1) (ISNI:0000 0004 0534 4718) 
9  Eli Lilly & Company, Indianapolis, USA (GRID:grid.417540.3) (ISNI:0000 0000 2220 2544) 
10  Biogen, Durham, USA (GRID:grid.417832.b) (ISNI:0000 0004 0384 8146) 
Publication year
2020
Publication date
Dec 2020
Publisher
Springer Nature B.V.
e-ISSN
23649534
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s41120-020-00034-7
ProQuest document ID
2400255268
Copyright
© The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.