Search results with tag "Toxicology assessment"

M7 (R1) Step 5 Assessment and control of DNA reactive ...

This document is intended to provide guidance for new drug substances and new drug products during ... The safety risk assessment principles of this guideline can be used if warranted for . ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in ... and/or computational toxicology assessment. A Threshold of ...

  Assessment, Principles, Guidance, Risks, Toxicology, Risk assessment principles, Toxicology assessment