Introduction to Quality by Design (QbD)

Chapter 1. Introduction to Quality by Design.- Chapter 2. Regulatory Aspects of Quality by Design (USFDA, PMDA, ICH, EMEA guidelines).- Chapter 3. Criteria for selection of Design (PAT, CMA,CPA,CQA,RMEA).- Chapter 4. Analytical Quality by Design.- Chapter 5. API Quality by Design.- Chapter 6. Quality by Design for formulation development.- Chapter 7. Quality by Design for oral formulations (tablets, spheroids).- Chapter 8. Quality by Design for topical formulations.- Chapter 9. Quality by Design for parenteral formulations.- Chapter 10. Quality by Design approach for Novel Drug Delivery Systems.- Chapter 11. Quality by Design for herbal products/ formulations.- Chapter 12. Quality by Design in Quality Assurance.- Chapter 13. Quality by Design in pharmaceutical packaging.- Chapter 14. Quality by Design and Clinical Trials.- Chapter 15. Applications of Quality by design.- Chapter 16. Quality by Design and Marketing.- Chapter 17. Conclusions and Future perspective.

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• Farmacologia
• Tecnologia farmacêutica
• Biotecnologia
• Química
• Medicina pré-clínica: ciências básicas
• Indústrias químicas

Analytical QbD;Critical Material Attributes (CMA);Pharmaceutical Research;Critical Process Parameter (CPP);Critical Quality Attributes (CQA);Target Product Profile (TPP);Target Product Quality Profile (TPQP);Formulation QbD;Quality by Design (QbD),