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Title Efficacy and safety of name of antimalarial drug(s) or drug combination(s) for the treatment of uncomplicated Plasmodium falciparum malaria in district, province, country Study site(s) Site
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Safety and efficacy refer to the evaluation of whether a product, such as a medication or medical device, is safe for use and effective in achieving its intended purpose.
Manufacturers, developers, and companies that produce drugs, biologics, or medical devices are typically required to file safety and efficacy data with regulatory agencies.
To fill out the safety and efficacy submission, the applicant must compile clinical trial data, preclinical research, and other relevant information that demonstrates the product's safety profile and therapeutic effectiveness.
The purpose of assessing safety and efficacy is to ensure that products are safe for public use and effective for their intended therapeutic use before they are approved for market release.
The information that must be reported includes clinical trial results, adverse effects, pharmacological data, manufacturing processes, and any relevant preclinical studies.
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