DoE, QbD and PAT in Pharmaceutical Development
1. Introduction 2. Historical Context and Regulatory Push 3. Understanding the Three Pillars 3.1 Quality by Design (QbD) – The Framework Key Concepts: Stages of Application: Early development → Technology transfer → Lifecycle management. Regulatory Basis: ICH Q8(R2), Q9, Q10, Q11, Q12, Q13, Q14. Tools: Risk assessments (FMEA, Ishikawa, Fault Tree Analysis), control strategy design….