European Agency for Evaluation of Medicinal Products
Clinical investigation of medicinal products in the treatment of Parkinson's disease (CPMP note for guidance). European Agency for Evaluation of Medicinal Products
Abstract
These notes are intended to provide guidance for the evaluation of drugs in the treatment of Parkinson's disease. They should be read in conjunction with the Directive 75/318/EEC and 83-570/EEC and current and future EC and ICH guidelines, especially those on: Studies in support of special populations: geriatrics (ICH E7). The extent of population exposure to assess clinical safety for drugs intended for long-term treatment in non life threatening conditions (ICH E1). General considerations for clinical trials (ICH-E8). Statistical principles for clinical trials (ICH-E9). Pharmacokinetic studies in man Clinical testing of prolonged action forms, with special reference to extended release forms. Dose response information to support product authorisation
Source and rights
Published by European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology, 1999. The guideline itself is at the source linked here.
Prognia summarises this guideline for reference and education. It is not medical advice. Always check the official guideline and current local protocols before acting on it.
At a glance
- Organisation
- European Agency for Evaluation of Medicinal Products
- Published
- 1999
- Applies to
- 🇪🇺 Europe
- Country of origin
- 🌐 International
- Scope
- Regional
- Journal
- European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
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