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Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01)
Although biodegradable poly(lactide-co-glycolide) (PLGA) polymers have been utilized extensively for the controlled release of peptide drugs, there is still a lack of in-depth understanding of peptide-polymer interaction in PLGA based microspheres.
The purpose of the present study is to develop
a systematic approach to assess the peptide-polymer interaction in PLGA based microsphere dosage forms.
The developed approach should be able to identify the different types of peptide-polymer interactions, characterize and quantify related peptide degradation impurities (e.g., acylation peptide adducts), and determine the formulation parameters, hydration and degradation factors, and manufacturing processes responsible for facilitating peptide-polymer interaction.
The results from this study will provide better understanding of peptide-polymer interaction in PLGA based drug delivery systems, which will help the Agency in developing recommendations for evaluation of generic microspheres containing peptide drugs.
The purpose of the present study is to develop
a systematic approach to assess the peptide-polymer interaction in PLGA based microsphere dosage forms.
The developed approach should be able to identify the different types of peptide-polymer interactions, characterize and quantify related peptide degradation impurities (e.g., acylation peptide adducts), and determine the formulation parameters, hydration and degradation factors, and manufacturing processes responsible for facilitating peptide-polymer interaction.
The results from this study will provide better understanding of peptide-polymer interaction in PLGA based drug delivery systems, which will help the Agency in developing recommendations for evaluation of generic microspheres containing peptide drugs.
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-16-012
Additional Information of Eligibility:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U. S. Organization are not eligible to apply.
Foreign components, are not allowed.
Full Opportunity Web Address:
Contact:
Agency Email Description:
Agency Email:
eric.bozoian@fda.hhs.gov
Date Posted:
2016-03-17
Application Due Date:
2016-05-20
Archive Date:
2016-06-19
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