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The discussions around “unstructured data” vs. “structured data” in the context of pharmaceutical submissions have begun in earnest. Catch up with the debate.
As I talk to people about managing process development activities under a Quality-by-Design framework (QbD), people equate Quality-by-Design (QbD) with Design of Experiments (DOE). There are important differences.
The eCTD format provides large amounts of unstructured text in PDF format which leads to lengthy and redundant reviews because the key information is buried in the documents.
The TPP is a dynamic summary that changes as knowledge of the drug increases from preclinical and clinical studies. Learn more about this critical tool.
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