在临床试验中QTL和二次极限值的有效定位基于风险的监测

Vladimir Shnaydman1

  • 1ORBee Consulting, 57 East Bluff Rd., Ashland, MA, 01721, USA. vladimir.shnaydman@orbeeconsulting.com.

概括

本研究提出了临床试验风险减轻的新框架,优化了资源配置,并为有限的应急预算制定了操作规则. 它通过整合基于风险的质量管理和基于风险的监测来确保有效的药物开发.

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