- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > investigational product - clinical trials
- Keywords > WHO expert committee
(1995; 36 pages) [French] [Spanish]
10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
The sponsor is responsible for ensuring that the investigational pharmaceutical product(s) and, if applicable, comparator products supplied for the clinical trial are of appropriate quality and subject to quality assurance procedures (see Section 5.11).
If significant changes are made in the formulation of the investigational or comparator product during the course of the trial, the results of additional studies (e.g. on the stability, comparative dissolution rate or, as appropriate, comparative bioavailability) should be made available before the new formulation is used in the trial. The studies would demonstrate that the changes would not be expected to alter the pharmacokinetic profile or other clinical characteristics of the product.