Medicamentos
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ICH
- M4Q (CTD - Quality)
- Q1A(R2) - Stability
- Q1B - Photostability
- Q1E - Stability - Evaluation
- Q2(R1) - Analytical validation
- Q3A(R2) - Impurities in APIs
- Q3B(R2) - Impurities in drug products
- Q3C(R7)- Residual solvents
- Q3D(R1) - Elemental impurities
- Q6A - Specifications
- Q6A - Decision trees
- Q7 - GMP APIs
- Q11 - Development of APIs
- Q11 - Q&A
- M7(R1) - Mutagenic impurities