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Biotechnology-Derived Drug Products: Formulation Development
- Target Product Profile
- Dosage and Administration
- Dosage Forms and Strengths
- How Supplied
- Storage and Handling
- Physical/Chemical Properties
- Critical Quality Attributes and Formulation Development
- Design of Experiments (DOE)
- Thermal Stability
- Accelerated Stability Studies
- Solubility and Colloidal Stability
- Chemical Stability
- Article of Further Interest
- References
Abstract
The aim of formulation development is to design stable formulations to achieve clinical and commercial goals, by
Investigating stability.
Testing physical conditions and excipients to increase stability.
Understanding the mechanisms behind instability.
Changing formulation to prevent product instability.
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