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J Basic Pharmacol Toxicol. 2020;4(2):132913JOURNAL OF BASIC PHARMACOLOGY AND TOXICOLOGY Original Research ArticleToxicological evaluation of Mojeaga herbal remedy on experimental animals MacDonald
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Efficacy and safety refer to the effectiveness of a product, particularly in the context of pharmaceuticals or medical devices, and its potential side effects or risks when used by patients.
Manufacturers, sponsors, or researchers of pharmaceuticals and medical devices are typically required to file for efficacy and safety assessments.
To fill out the efficacy and safety documentation, applicants must provide detailed clinical trial data, statistical analyses, and reports that outline the product's performance and safety profile.
The purpose of assessing efficacy and safety is to ensure that the product is both effective for its intended use and safe for consumers, thereby protecting public health.
Information that must be reported includes clinical trial results, adverse event data, demographic data of trial participants, and any regulatory submissions related to previous studies.
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