Drug Development: The Short Story
6. Attrition Rate
The overall attrition rate for developing a drug is currently calculated to be 10,000:1. The averages breakdown roughly as follows:
Chemistry will send an average of 10,000 New Chemical Entities to pharmacology and safety for testing. Only 10% of these will pass the criteria of activity and lack of toxic side effects which are set by the study team. Of the 1,000 which are approved for clinical study, 1% will show the combined safety and efficacy needed in the clinic. NDA submissions will be prepared for this group which will be sent to the FDA for review. Only 10% of these, on average, will pass the review process. The problems encountered in each of these phases will be explored in detail in subsequent sections.
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