Validation--how much can the world afford? Are we getting value for money?

M H Anisfeld
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Abstract

The author raises questions not usually considered in discussions of validation: "How much validation can the world afford?," "Are we getting value for money?," and "What's in it for the patient?." The paper develops the theme that, while validation is undoubtedly important, the pharmaceutical industry has not given adequate thought as to whether the benefits of validation outweigh the costs in implementation of validation.

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验证——世界能承受多少?我们是否物有所值?
作者提出了在讨论有效性时通常不会考虑的问题:“世界能承受多少有效性?”、“我们的产品物有所值吗?”、“对病人有什么好处?”本文提出的主题是,虽然验证无疑是重要的,但制药行业并没有充分考虑验证的好处是否超过实施验证的成本。
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