Assessment, pharmacological entity

Several of these factors (such as 1, 2, 3, and 7) are amenable to premarketing abuse-liability testing. Most abuse-liability testing is targeted to assess the pharmacological entity without regard to its formulation. The past decade has demonstrated that new formulations of old medications add a potentially dangerous twist to assessment of abuse liability. 

PREMARKETING ABUSE-LIABILITY TESTING 8.3.1 Assessment of Pharmacological Entity... 

Biopharmaceuticals represent a broad but discrete class of large molecular weight therapeutic entities that are characterized by their specific pharmacological activities and distinctive pharmacokinetics. The selection of an appropriate animal model is dependent on a combination of PD and PK factors. As described in this chapter, it is essential to understand the relationship of the basic pharmacology of a biopharmaceutical (signaling, receptor presence, binding properties, etc.) and the associated PK properties to that expected in humans, in order to select animal species that will have the most predictive value in safety assessments. 

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