- What major non-clinical ICH/FDA guidances relate to safety studies for the conduct of human clinical trials (in addition to M3R2)?
- What studies must be conducted in the nonclinical safety assessment for human clinical trials? Very briefly describe the purpose of each of the studies.
- What additional nonclinical studies may be required to assess studies on a case-by-case basis?
- Which R&D and Operations departments/functions are typically not subject to the Good Laboratory Practice regulations (excluding those covered by Good Manufacturing Practices)?
- What is the definition of toxicokinetic studies and what is their purpose?
- What is the primary purpose of non-clinical research and development?
- When planning long-term carcinogenicity studies in rodents for a new drug product, what are the factors that should be considered?
- In what situations, if any, might a drug product receive marketing approval before required carcinogenicity testing is conducted or completed?
- When conducting drug product stability testing, what drug product attributes should be tested?
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Non-clinical ICH/FDA guidances relate to safety studies
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