Q8: Pharmaceutical Development

Q8: Pharmaceutical Development

Pharmaceutical development, as described in ICH Q8 (R2), is the process of designing a quality product and its manufacturing process to consistently deliver the intended performance. The goal is to understand how formulation and process variables influence product...
Quality by Design (QbD) in Pharmaceuticals

Quality by Design (QbD) in Pharmaceuticals

Quality by Design (QbD) in Pharmaceuticals Definition:Quality by Design (QbD) is a systematic, risk-based, proactive approach to pharmaceutical development that emphasizes designing and building quality into the product from the very beginning, rather than relying...

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