Accelerated Predictive Stability Study of a Pediatric Drug Product for a Supplemental New Drug Application.
AAPS PharmSciTech
; 25(5): 128, 2024 Jun 06.
Article
in En
| MEDLINE
| ID: mdl-38844721
ABSTRACT
In this paper, we report two Accelerated Stability Assessment Program (ASAP) studies for a pediatric drug product. Whereas the first study using a generic design failed to establish a predictive model, the second one was successful after troubleshooting the first study and customizing the study conditions. This work highlighted important lessons learned from designing an ASAP study for formulations containing excipients that could undergo phase change at high humidity levels. The stability predictions by the second ASAP model were consistent with available long-term stability data of the drug product under various storage conditions in two different packaging configurations. The ASAP model was part of the justifications accepted by the health authority to submit a stability package with reduced long-term stability data from the primary stability batches for a Supplemental New Drug Application (sNDA).
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Chemistry, Pharmaceutical
/
Drug Stability
/
Excipients
Limits:
Child
/
Humans
Language:
En
Journal:
AAPS PharmSciTech
Journal subject:
FARMACOLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Switzerland
Country of publication:
United States