ich q9 (quality risk management)

How Does ICH Q9 Apply to Cancer Drug Development?

During cancer drug development, ICH Q9 can be used to assess and manage risks at each stage, from research and development to clinical trials and post-market surveillance. This involves identifying potential hazards associated with new cancer therapies, evaluating the likelihood and severity of these risks, and implementing control measures to minimize them. For example, ensuring the sterility of injectable cancer drugs is a critical aspect of risk management.

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