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The present mini-review focuses on major chemical discoveries, formulation developments, administration strategies and new products.
This work attempts a systematic analysis on recent formulation developments of both communities.
In addition, special emphasis is given to pharmaceutical aspects that are frequently minimized, but that, instead, may be useful for formulation developments and in vitro/in vivo correlations.
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Hence, some degree of formulation development work is almost always needed in developing a placebo liquid formulation.
The ultimate goal is to develop a computer software design aide to help with formulation development.
Hence, clinical relevance is directly built into early formulation development.
Formulation development presents significant challenges with respect to protein therapeutics.
This study demonstrated that biopharmaceutical formulation development for nebulization is feasible by means of imitating nebulizer related detrimental factors, allowing an accelerated and more economic formulation development.
During the course of formulation development, we could quickly identify manufacturability deficiencies in the lead formulation.
Tailored formulations can shield proteins and enhance permeation, but formulation development requires extensive screening approaches.
Analytical and Formulation Development is a central part of biologics process development.
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