QbD

Formulation

DoE, QbD and PAT in Pharmaceutical Development
ByPharma Lesson September 29, 2025September 29, 2025 Reading Time: 2 minutes

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: Regulatory Basis: ICH Q8(R2), Q9, Q10, Q11, Q12, Q13, Q14. Tools: Risk assessments (FMEA, Ishikawa, Fault Tree Analysis), control strategy design. Case Study Example: QbD applied to controlled-release tablet…

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Pharmaceutical Development

Pharmaceutical Development (Quality by Design) Summary
ByPharma Lesson January 30, 2025February 2, 2025 Reading Time: 2 minutes

ICH Q8 (R2) is a guideline issued by the International Council for Harmonization (ICH) that provides principles for Pharmaceutical Development under the Quality by Design (QbD) approach. The key focus of this guideline is to encourage a systematic, science-based approach to drug development that enhances product quality and process understanding. Objective of Pharmaceutical Development To…

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