Safety studies for a biopharmaceutical aim to define the pharmacologic and
toxicologic effects of the drug in animals that are predictive of the human
response. Studies aim to:
- Define safe starting doses / escalation schemes for clinical studies
- Identify target organs / tissues for toxicity and reversibility of
toxic effects
- Identify safety parameters for clinical monitoring
- Provide information on mechanism of action and determine the fate
of the test compound and how these may relate to toxicity and efficacy
Prior to performing safety studies in animals, the relevant species must be
selected, based upon the specificity of its pharmacological action and the nature
of the biopharmaceutical. For example, for monoclonal antibodies, this is achieved
by comparing the binding of the monoclonal antibody to human and animal tissues
as well as performing in vitro studies with human and animal cells
to confirm that antibody binding has the desired pharmacological effect.
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