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Step 5 Clinical trial phase 3
- Process validation.
- Stability studies.
- Update of CMC.
Step 4 Clinical trial phase 2
- Forced degradation study : identification of significant impurities.
- Investigational stability study.
- Reference standard synthesis of API: Analytical qualification.
- Validation of analytical methods (monograph)
Step 3 Clinical trial phase 1
- Specifications of API and raw materials.
- GMP production for first in man clinical trials.
- First analytical protocols for critical step of synthesis.
- Qualification of API analytical methods.
- First stability studies of API.
- CMC (chemistry manufacturing and controls) preparation pour IND and IMPD
Step 2 Preclinical studies
- Peptide characteristics: solubility studies, chemical and physical properties, conditions of purification and drying.
Step 1 Feasibility studies