It is known that after drug registration, it is possible to conduct a clinical study of the combination of this drug with another registered drug (4th phase of an interventional clinical study). But is it possible to conduct clinical trials of a combination of unregistered drugs (clinical trials of the third phase)?
No, the safety and efficacy of the drugs need to be proved individually through clinical trails before they are combined.
Although the safety and efficacy of the drugs need to be substantiated individually, these studies can be done prior to a registration trial. Several combination drugs have been approved by the FDA where each component of the combination was a novel entity.
To conduct Phase 3 clinical studies with an unapproved drug either alone or in combination, one needs to have preclinical pharmacodynamic, kinetic and safety data as well as human/clinical pharmacokinetic and safety data on the said fixed-dose combination along with the requisite regulatory and ethical committee approvals.
It is unethical to conduct phase III trial of unregistered drug individually or in combination. It has to go through all phases including pre-clinical studies where safety and efficacy parameters are assessed before conducting phase III. Last year CDSCO (DCG-I) has banned so many FDC (Fixed Dose Combination medicines) as they fail to meet safety parameters.
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