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Official Title:NCT Number:
Document Type:
Date of the
Document:A phase 1/2 study of ABI009 (nabrapamycin) with
pazopanib (ORIENT) in patients with advanced
nonadipocytic soft tissue sarcomas
NCT03660930
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What is safety and efficacy of?
Safety and efficacy refer to the extent to which a product is both safe and effective in achieving its intended purpose.
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Manufacturers and developers of products are typically required to file safety and efficacy reports with regulatory agencies.
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Safety and efficacy reports are typically filled out by providing data on the product's safety profile, effectiveness, and any potential side effects.
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The purpose of safety and efficacy reports is to ensure that products on the market are safe for consumers to use and that they actually do what they claim to do.
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Information that must be reported includes clinical trial data, adverse event reports, and any post-marketing surveillance data.
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