Gallagher et al. 2011
Unassessable refers to situations where the medicine is administred on one occasion (e.g. vaccine), the patient receives intermittent therapy (e.g. Chemotherapy), or is on medication which cannot be stopped (e.g. Immunosupressants).
Examples of objective evidence:
- positive laboratory investigations of the causal ADR mechanism (not those merely confirming the adverse reaction)
- supra-therapeutic drug levels
- good evidence of dose-dependent relationship with tpxicity in the patient
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