- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
1.3 Supporting data for the investigational product
Pre-clinical studies that provide sufficient documentation of potential safety and eventual clinical application of a pharmaceutical product are a prerequisite for a clinical trial. Information about manufacturing procedures and data from tests performed on the actual product should establish that the it is of suitable quality for the intended investigational use. The pharmaceutical, pre-clinical and clinical data should be adapted to the appropriate phase of the trial, and the amount of supporting data should be appropriate to the size and duration of the proposed trial. In addition, a compilation of information on safety and efficacy of the investigational product obtained in previous and ongoing clinical trials is required for the planning and conducting of subsequent trials.