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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