| Comprehensive Studies |
Dependable Studies |
 Physico-chemical properties |
| Excipient compatibility |
| Formulation optimization |
| Dissolution method development |
| Compatibility studies |
| Prototype formulation evaluation |
| Stability studies |
| Development of lyophilization cycles |
| CMC support |
| Process engineering of lyo dosage forms |
| Container closure selection and evaluation |
| Assistance in proposing drug product specifications |
|
| Hygroscopicity studies |
| Characterization (e.g., DSC and TGA) |
| Microscopic evaluation |
| Particle size evaluation |
| Aqueous solubility measurements |
| Excipient compatibility |
| Solubility in co-solvent |
| Solubilization strategy |
| Solution stability |
| Solid-state stability |
| Salt evaluation |
| Potential for solvate, hydrate or polymorphism |
