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The 'pepper pot' principle: ensuring the most effective drugs reach the market faster.

Publication: Pharmaceutical Technology Europe
Publication Date: 01-JUL-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
Pharmaceutical companies are under constant pressure to reach critical Phase I studies earlier and reduce development costs. Increasing the throughput of compounds for development may help achieve these goals by ensuring that potential drug candidates receive the maximum investment of resources by 'failing faster'. To this end, many pharmaceutical companies are exploring the potential of simplified dosage forms to reduce the need for costly stability and preformulation studies for compounds that fail clinical trials. Automated microdosing of APIs into capsules is one method that could help accelerate formulation development and ensure that the most effective drugs reach the market faster.

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In today's cash-starved economic climate, both large and small pharmaceutical companies are striving to shorten drug development times to enable drugs to be marketed for the maximum amount of time before their patent protection expires. To date, the FDA has recognized and published 76 opportunities in the drug discovery and development cycle, which are grouped into six technology areas, including computer models, in vitro tests, qualified biomarkers and innovative study designs. (1) These could help determine and predict the safety and efficacy of drug candidates more rapidly, as well as how easily drug candidates could be manufactured.

In 2004, the FDA also introduced its Critical Path initiative, which helps companies focus on specific areas where drug discovery and development timelines can be reduced. (2) One section of this initiative seeks to reduce the time and resources spent on candidate drugs that are unlikely to succeed. For a drug candidate to 'fail faster', new equipment and software are required that distinguishes a promising candidate from other...

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