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2008 Draft FDA guidance on the ISE
The 2008 Draft FDA guidance on the ISE provided in this session provides a lot of detail on pooled analyses
The 2008 Draft FDA guidance on the ISE provided in this session provides a lot of detail on pooled analyses (also
referred to in the guidance as “meta-analyses”).
Based on the information in this guidance, what are the benefits of pooling efficacy data across studies? What might be some of the inherent problems in pooling data
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