首页   按字顺浏览 期刊浏览 卷期浏览 Releasing the Human Spirit in Developing DrugsIncreasing Clinical Pharmacokinetics Prod...
Releasing the Human Spirit in Developing DrugsIncreasing Clinical Pharmacokinetics Productivity

 

作者: J Robert Powell,   Edward J. Randinitis,   Jack A. Cook,   Richard L. Lalonde,  

 

期刊: International Journal of Pharmaceutical Medicine  (ADIS Available online 2004)
卷期: Volume 18, issue 1  

页码: 13-17

 

ISSN:1364-9027

 

年代: 2004

 

出版商: ADIS

 

关键词: Regulatory process

 

数据来源: ADIS

 

摘要:

A common problem in drug development is that highly trained people become trapped in doing the work of their respective discipline without taking individual responsibility for the most important questions. ‘Getting the dosage regimen right’ is a fundamental problem in drug development that is often not well performed. The experience described here transformed a department from completing required clinical pharmacokinetic studies to focusing on the most important questions in dosage regimen design that did not have a unique solution. Elements of the story include vision, quality, best practice, automation, transformation and impact. Productivity was increased by 81% within 2 years by one measure and there was a substantial positive financial impact.

 

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