Arestin
| Dosage Form | Extended release microspheres |
| Release Duration | 21 days |
| Excipients | PLGA |
| Product Label | |
| Orange Book App No. | 050781 |
CQA
| Quality attribute | N | Value | Std. dev. | Source |
|---|---|---|---|---|
| Particle Size - D50 (μm) | ████████ | ████████ | ████████ | ████████ |
| Pore Size - D50 (μm) | ████████ | ████████ | ████████ | ████████ |
| API Size - D50 (μm) | ████████ | ████████ | ████████ | ████████ |
| Roundness | ████████ | ████████ | ████████ | ████████ |
| Density (g/cm^3) | ████████ | ████████ | ████████ | ████████ |
| Porosity (vol%) | ████████ | ████████ | ████████ | ████████ |
| API (vol%) | ████████ | ████████ | ████████ | ████████ |
Images
