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Quality, during drug development

Two fundamental product quality questions posed during drug development... [Pg.325]

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all... [Pg.91]

This chapter has been divided into three distinct sections, all of which focus on a forward quality perspective to ensure that the highest level of quality assurance (QA) and durable compliance is maintained throughout the drug development process, during initial product launch, and after the product has been commercialized. [Pg.493]

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See also in sourсe #XX -- [ Pg.5 ]



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During development

Quality development

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