Clinical investigation of medicinal products in the treatment of Parkinson's disease (CPMP note for guidance). European Agency for Evaluation of Medicinal Products.
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
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
D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D008996:Monoamine Oxidase Inhibitors; D007980:Levodopa