The Effect of Different Preparation Methods on the In Vitro and In Vivo Performance of Solid Dispersion Formulations (U01)
The objective of this study is to investigate the in vitro and in vivo performance for solid dispersion drug products made from different manufacturing processes or polymer carriers, as well as their performance consistency during storage and among batches. The investigation should identify critical process parameters and critical quality attributes for solid dispersion made from different preparation methods, and develop discriminating analytical methods.
Detailed Descriptions:
The following studies should be conducted for the purpose of this project:
(1) Identify model drugs, and prepare amorphous solid dispersion us...
Source: Grants.gov - April 18, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01)
The objective of this study is to conduct a retrospective analysis about the impact of generic immunosuppressants on short term acute rejection and long term patient graft survival since the introduction of generic immunosuppressants. The outcome of this study will help respond to public concerns regarding the interchangeability of generic immunosuppressants and improve review practices of generic immunosuppressants if necessary. The retrospective analysis will also aid in the design of prospective studies to investigate generic substitution for immunosuppressants.
Detailed Descriptions:
The model drugs to be studied shou...
Source: Grants.gov - April 18, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
Prospective Studies on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft survivals (U01)
The objective of this study is to conduct prospective clinical studies to investigate the impact of generic immunosuppressants on short term acute rejection and long term patient graft survival. The outcome of this study will help respond to public concerns regarding the interchangeability of generic immunosuppressants and improve review practices of generic immunosuppressants if necessary. The results obtained from this study can be compared to those of retrospective analysis, providing comprehensive perspectives and better research options regarding generic immunosuppressant interchangeability.
Detailed Descriptions:
Th...
Source: Grants.gov - April 18, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
