Task Development of Predictive Degradation Models and Determination of Bioequivalence of Pharmaceutical Preparations Contained in the Medical Kits on Board the International Space Station (Completed)
Last Published:  07/30/21 01:05:34 PM (Central)
Short Title: Pharm Degradation
Responsible HRP Element: Exploration Medical Capability
Collaborating Org(s):
National Space Biomedical Research Institute (NSBRI)
Funding Status: Completed - Task completed and produced a deliverable
Procurement Mechanism(s):
Solicited
Aims:
The following specific aims will be pursued to accomplish the research goal:
1) Establish validated HPLC-MS/MS assay methods for identification and quantification of API and degradation products of the selected formulations.
2) Characterize degradation profiles and API content of medications received from ISS and compare with existing data from ISS Payload and irradiation studies.
3) Conduct ground-based accelerated stability studies with matching set of medications selected for the above aims, to develop predictive degradation models.
4) Estimate bioequivalence between earth-based reference control and Space X returned formulations in a small animal model (rat) to examine integrity and performance of medications stored on board the ISS.
Resources (None Listed)
Mappings