Establishing a preclinical decision framework for drugs
Preclinical safety programs often follow a standard template to determine off-target effects.
However, some molecule classes and targets may raise other concerns. A well-informed, well-structured workflow needs to be thorough both in terms of information sources and methodology.
Using a theoretical drug indicated for metastatic renal cancer, in this paper, Dr. William B. Mattes examines the preclinical workflow for pharmaceutical safety analysis, including a study of:
- The regulatory documentation for the target
- Preclinical and clinical safety findings for approved drugs
- Safety concerns raised in regulatory documents
- Strategies used for similar drugs and their success
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