| Study description | | | | Estimated duration, months |
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| 3.2. Extended studies |  |
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E.g., repeated dose ADME, placental transfer, metabolism in vivo, excretion into milk, enterohepatic circulation in rat and one nonrodent |
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1.5. to 8.2. (earlier in Japan) |
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| 4. Safety pharmacology |
| 4.1. Basic studies on all systems | | 1.1. | |
| 4.2. Extended studies | E.g., safety pharmacology of metabolites | 8.2. | |
| 5. Drug substance manufacturing |
| 5.1. GLP laboratory process | | 6.1. | |
| 5.2. GLP pilot plant process | | 6.1. | |
| 5.3. GMP pilot plant process | | 6.2. | |
| 5.4. Final process | Optimized and validated production scale process | 6.5., 8.2. | |
| 6. Drug product manufacturing process |
| 6.1. Preclinical formulation | | 2.1.2.6. | |
| 6.2. Phase I formulation | A solution may initially be sufficient | 1.1. | |
| 6.3. Phase II formulation | Should have bioavailability of final formulation | 1.4. | |
| 6.4. Final (phase III) formulation | | 1.5. | |
| 6.5. Formulation scale-up and validation | | 8.2. | |
| 7. Analytical |
| 7.1. Substance characterization | Including method development | 8.1., 8.2. | |
| 7.2. Formulation characterization | Including method development | 8.1., 8.2. | |
| 7.3. Stability of drug substance | | 8.1., 8.2. | |
| 7.4. Stability of clinical formulation | Sufficient to support length of study | 8.1., 8.2. | |
| 7.5. Stability of final formulation | Sufficient to support intended shelf life | 8.1., 8.2. | |
| 8. Regulatory |
| 8.1. Clinical trials submission (IND) | | 1.1. | |
| 8.2. Marketing approval submission (NDA) | | | |