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Controlled-release (CR) long-acting formulations are designed to release a medication at a predetermined rate, allowing for prolonged therapeutic effects and reduced frequency of dosing.
Pharmaceutical manufacturers who produce controlled-release long-acting medications are required to file the appropriate documentation with regulatory authorities.
To fill out the documentation for controlled-release long-acting formulations, manufacturers must provide details on formulation, dosage, release mechanism, and stability data as per regulatory guidelines.
The purpose of controlled-release long-acting formulations is to improve patient compliance by minimizing the frequency of dosing while maintaining therapeutic drug levels.
Manufacturers must report active ingredients, dosage forms, release characteristics, clinical data, and safety information related to controlled-release long-acting drugs.
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