首页> 外文期刊>Chimica oggi: international journal of chemistry and biotechnology >WHAT ARE THE FUNDAMENTAL CHARACTERISTICS A CRO/CAAO SHOULD HAVE TO HELP SPONSORS INCREASE THEIR CHANCES OF SUCCESSFUL OUTCOMES? IS QUALITY BY DESIGN A MUST?
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WHAT ARE THE FUNDAMENTAL CHARACTERISTICS A CRO/CAAO SHOULD HAVE TO HELP SPONSORS INCREASE THEIR CHANCES OF SUCCESSFUL OUTCOMES? IS QUALITY BY DESIGN A MUST?

机译:CRO / CAAO应该采取哪些基本特征来帮助赞助商增加成功成果的机会?设计品质必须吗?

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摘要

Albemarle believes that Quality by Design (QbD) is absolutely critical to establishing a robust and reproducible validated process that will be acceptable to regulatory authorities and meet sponsor's supply requirements. Every process we develop today undergoes a comprehensive development and validation program predicated on the principles of QbD.
机译:Albemarle认为,设计质量(QbD)对于建立健壮且可重复的经过验证的过程至关重要,该过程将为监管机构所接受并满足赞助商的供应要求。我们今天开发的每个过程都将根据QbD原则进行全面的开发和验证程序。

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