PBBM Report Template: Considerations for Improved Quality in View of Regulatory Submissions
Virtual Event
Sponsored by the Regulatory Advisory Committee Pharmaceutical innovators and generic companies employ Physiologically Based Biopharmaceutics Models (PBBMs) to inform drug product development and may be able to waive clinical pharmacokinetic studies for changes occurring both before and after product approval. The 2023 M-CERSI workshop titled "PBBM Best Practices for Drug Product Quality: Regulatory and Industry […]
