Risk communication is a two-way exchange of information on the risks and benefits of a medicine. Patients, companies, and health authorities all have important roles to play in risk...
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.
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be...
Epidemiology is the study of the various factors influencing the occurrence, distribution, or prevention and control of disease, injury, and other health-related events in a defined human population.
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability,...
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
Risk factors are those factors linked to poor health, disability, disease, or death. Generally, risk factors can be classified as behavioural, physiological, demographic, environmental, or genetic. Reducing exposure to...
Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product...
