title: 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
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D018491:Dopamine Agonists / Q000627:therapeutic use; D004341:Drug Evaluation / Q000379:methods; D004359:Drug Therapy, Combination; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000627:therapeutic use; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D018579:Patient Selection
chemical_list: D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D008996:Monoamine Oxidase Inhibitors; D007980:Levodopa