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THE PHARMA REVIEW (MARCH – APRIL 2015)

Exploratory IND: A Critical Overview on Clinical Trial Paradigm Shift

Dr. Papiya Bigoniya & Mr. Dharmesh Bigoniya

Introduction: The time and money consumed during the clinical trials are not the only reason related to less number of new drugs that successfully cross the ‘Critical Path’, the major issue is the chances of failure progressively in advancing with each phase of trial. A new drug compound entering phase 1 testing is estimated to have only 8% chance to be approved as a therapeutic agent to enter in the market1. Nearly 40% of the investigational new drugs (INDs) fail in the phase 1 trials owing to the inappropriate pharmacokinetics of the test compound. New compounds that successfully pass through phases 1 and 2 of clinical trials still has 50% chances of failure in phase 3 when it is intended to show actual therapeutic efficacy on large number of patients2. 

 

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