Can I read Risk-Based Pharmaceutical Development Guide on EtoBox?

Risk-Based Pharmaceutical Development Guide by Jorge Humberto Herrera is a document available to read on EtoBox.

What is Risk-Based Pharmaceutical Development Guide about?

This document discusses ICH Q8, Q9, and Q10 guidelines and their role in a risk-based pharmaceutical development approach. It advocates using a thorough understanding of formulations and manufacturing processes to develop quality by design with built-in quality, using tools like Process Analytical Technology (PAT) and risk management. Real-time release testing is presented as an alternative to end-product testing that relies on in-process monitoring and prediction of quality attributes.

Author

Jorge Humberto Herrera

Language

EN