Risk-Based Approaches to Stability Study Design in Pharmaceuticals
Risk-Based Approaches to Stability Study Design in Pharmaceuticals Implementing Risk-Based Strategies in Stability Study Design for Pharmaceutical Products Traditional stability study designs often adopt a one-size-fits-all model. However, evolving regulatory expectations and cost-efficiency pressures are driving pharmaceutical companies to adopt risk-based approaches to stability testing. Rooted in ICH Q9 principles, this methodology enables smarter resource…
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