The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative...
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose...
Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and...
Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations...
Introduction Development of a cure/treatment for Duchenne, by the Duchenne Parent Project in collaboration with Leiden University and Prosensa (Biotech partner) – GSK. Description of the case Development of...
Herbal medicines are based on extracts from plants or parts of plants that have healing properties. They have been used for hundreds of years and can be seen as...
To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the...
Introduction Involvement of the charitable foundation ‘Children with SMA’ (spinal muscular atrophy) to establish contact with the academic institution ‘Institute of Neurology, Psychiatry and Narcology of NAMS Ukraine’ to...
