Secondary pharmacodynamics

Secondary pharmacodynamic studies investigate the mode of action or effects of a substance not related to its desired therapeutic target. 

Drug activity related to proposed indication Secondary pharmacodynamics Pharmacology summary Pharmacology conclusions Safety pharmacology Neurological effects Cardiovascular effects Pulmonary effects Renal effects... 

GLP/S7A Core battery tests should be conducted according to GLP Follow-up and supplemental studies should be conducted according to GLP as far as possible deviation should be justified and impact discussed Primary and secondary pharmacodynamic studies need not be conducted according toGLP... 

Characterisation of the activity of primary interest must be accompanied by an equally thorough evaluation of the pharmacology of the compound at other receptors and in other systems. Secondary pharmacodynamic activity refers to the pharmacology of a substance not related to its desired therapeutic target. Studies of secondary pharmacodynamic activity may reveal desired or undesired properties. For example, a substance may be found to have the desired effect at sites or in systems other than the one first considered. On the other hand, non-selectivity may imply that the doses producing the desired therapeutic effect are likely to be accompanied by adverse effects. In addition to this secondary pharmacodynamic activity, a package of so-called safety pharmacology studies should be completed. 

In addition to the categorizations described above, two other categories of pharmacodynamic studies were described in the ICH S7A guidelines at the request of ICH M4S EWG (Anon 2001a, d). These included the primary pharmacodynamic and secondary pharmacodynamic smdies, which were described in order to distinguish the requirement for GLP compliance for safety pharmacology smdies, but not for primary or secondary pharmacodynamic smdies. 

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