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What is pediatric compounds 0112?
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Manufacturers or sponsors of pediatric medications are required to file pediatric compounds 0112.
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Pediatric compounds 0112 must be filled out with detailed information on the medication, testing data, and proposed uses for children.
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The purpose of pediatric compounds 0112 is to ensure that medications used in children are safe and effective for their specific needs.
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Information such as pharmacokinetics, pharmacodynamics, safety data, and dosing information must be reported on pediatric compounds 0112.
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