Evaluation of a Quality by Design (QbD) Approach for Process Development and Scale-Up of a Novel ALS Drug Product

Evaluation of a Quality by Design (QbD) Approach for Process Development and Scale-Up of a Novel ALS Drug Product

This poster discusses a stepwise Quality-by-Design (QbD) approach consistent with ICH Q8 (R2) and associated regulatory guidelines to build quality into a Novel ALS drug product.

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