Unit 3: Analytical Method Development
This unit provides a comprehensive, research-backed exploration of analytical method development in pharmaceuticals, integrating ICH Q2(R1) and Q14/Q2(R2) guidelines with recent advancements such as AQbD and DoE. It emphasizes the importance of risk assessment, optimization, and lifecycle thinking to ensure reliable, robust, and regulatory-compliant analytical procedures.
Analytical method development is establishing a scientifically sound procedure to accurately and precisely measure an analyte within a specific matrix. It ensures the method’s suitability for its intended purpose and alignment with regulatory requirements.
Key Points
Creates fit‑for‑purpose analytical procedures.
Forms basis for validation and lifecycle management.
Bridges laboratory findings and regulatory compliance.
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