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NKDKD__ _ _ _ _ _ _ _ _ _ _ _ !Original InvestigationNovel OnceDaily ExtendedRelease Versus TwiceDaily in De Novo Kidney Transplant Recipients: TwoYear Results of Phase 3, DoubleBlind, Randomized
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Novel once-daily extended-release refers to a formulation of medication designed to be released slowly over a 24-hour period, allowing for once-daily dosing.
Pharmaceutical companies or manufacturers that develop or market novel once-daily extended-release formulations are required to file for regulatory approval.
To fill out novel once-daily extended-release applications, companies must provide detailed information including formulation data, clinical study results, and safety and efficacy information according to regulatory guidelines.
The purpose of novel once-daily extended-release formulations is to improve patient compliance by reducing the frequency of dosing and to maintain therapeutic drug levels over an extended period.
Information required includes drug composition, pharmacokinetics, clinical trial results, dosing instructions, and safety profiles.
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