Glossary

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  • PharmacotherapyPharmacotherapy is the treatment of diseases using conventional medicines (not biologic medicines).
  • PharmacovigilancePharmacovigilance is the practice of detecting, assessing, understanding and preventing the adverse effects of medicines. Pharmacovigilance enhances patient safety and public health by providing reliable information on the risks and benefits of medicines.
  • Pharmacovigilance and Risk Assessment Committee[glossary_exclude]Pharmacovigilance and Risk Assessment Committee (PRAC) https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac[/glossary_exclude]  
  • PRAC[glossary_exclude]Pharmacovigilance and Risk Assessment Committee (PRAC) https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac[/glossary_exclude]  
  • Phase 0 TrialsPhase 0 trials are conducted with sub-therapeutic doses to see if a medicine behaves in the body in the way that earlier laboratory studies (non-clinical trials) predicted.
  • Phase I TrialsNormally, the first studies in humans with a new medicine are Phase I trials.Phase I trials are usually conducted in a small number of healthy volunteers (although some trials recruit patients). The aim of Phase I trials is to find out the safe dose range, and to look for any side effects. The(...)
  • Phase II TrialsPhase II trials are generally the first studies with a new medicine in patients. They are usually conducted in a small number of patients who are monitored closely. These trials are often larger than Phase I trials.Phase II studies are designed to find out if the medicine has a beneficial(...)
  • Phase III TrialsPhase III trials are generally large (comprising thousands of patients) and involve several study sites, sometimes in different countries. They compare the new medicine to existing treatments or a placebo, in order to show the safety and efficacy of the new medicine. Most Phase III trials are(...)
  • Phase IV TrialsPhase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use.Phase IV studies are also known as post-authorisation safety studies (PASS) and may be voluntary or imposed by the regulatory authorities. The possibility also exists of requesting(...)
  • Physical healthPhysical health is defined as the condition of your body, taking into consideration everything from the absence of disease to fitness level.Physical health is critical for overall well-being, and can be affected by: Lifestyle: diet, level of physical activity, and behaviour (for instance,(...)

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