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Perspectives and Insights on N04 - Anti-Parkinson Therapeutic Class Drugs: From Development to Submission of a New Drug Submission (NDS) in Canada

Perspectives and Insights on N04 - Anti-Parkinson Therapeutic Class Drugs: From Development to Submission of a New Drug Submission (NDS) in Canada

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Original abstract

Parkinson's disease (PD), caused by the loss of dopaminergic neurons, is treated symptomatically using the anti-Parkinson (N04) therapeutic class. The gold standard for managing motor symptoms remains levodopa combined with COMT and MAO-B inhibitors. New approaches, such as inhalation devices and continuous infusion, are designed to reduce levodopa-induced dyskinesia (LID) and motor irregularities. Adherence to Health Canada's CTD-based New Drug Submission (NDS) requirements for efficacy, safety, and quality is necessary when developing N04 medications in Canada.

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