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The condition of being protected against consequences of failure, error or any other event which could be considered non-desirable. The safety of a medical product concerns the medical risk to the patient, usually assessed in a clinical trial by laboratory tests, vital signs, adverse events and other special safety tests.
Safety pharmacology studies predict whether a medicine is likely to be found unsafe when administered to human populations within the therapeutic range. Safety pharmacology studies aim to prevent the use of unsafe medicines.
Normally, results from previous safety pharmacology studies and effects related to the therapeutic effects of the medicine are considered. Safety pharmacology uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform benefit-risk assessments. Safety pharmacology includes a regulatory requirement to predict the risk of rare lethal events. The vigilant post-marketing surveillance (PMS) efforts of regulatory authorities are necessary to detect the existence of a rare adverse event occurrence after approval for human use.
The safety specification of a medicinal product is a summary of the important identified risks of a medicinal product, important potential risks, and important missing information. It should also address the populations potentially at risk, and any outstanding safety questions which may benefit from further investigation to refine understanding of the benefit risk profile during the post-authorisation period. In the RMP, the safety specification will form the basis of the pharmacovigilance plan, and the risk minimisation plan. It is one of the three pillars of the risk management plan.
In a clinical trial, the sample size is the number of patients or observations made. There must be enough patients or observations so that differences between groups within the trial can be detected. An estimate of sample size is required and must be specified in the study protocol before recruitment starts. It is also necessary to control the probability with which a real effect can be identified as statistically significant. Too few patients or observations will mean that real effects might not be detected, or they will be detected but at a level that is statistically insignificant (a Type II error, which is directly proportional to sample size). It is just as true that it is unjustified for a medicine to be tested on too many patients.
In pharmaceutical development, scale-up refers to the transition of a manufacturing process from lab scale (typically milligrams/grams) to plant-scale or commercial scale (typically kilograms/tonnes).
Scientific Advice Working Party
The Scientific Advice Working Party (SAWP) within the European Medicines Agency (EMA) provides scientific advice and protocol assistance to companies developing medicines. The SAWP was established by the EMA™s Committee for Medicinal Products for Human Use (CHMP).
It is a multi-disciplinary group with expertise in non-clinical safety, pharmacokinetics, methodology and statistics, and in therapeutic fields for which there are frequent requests or other specific fields such as cardiology, oncology, diabetes, neurodegenerative disorders and infectious diseases including human-immunodeficiency-virus (HIV) infection. Membership includes representatives from the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), and the Committee for Advanced Therapies (CAT).
The SAWP develops integrated views on quality relating to the development of medicines non-clinical and clinical safety and efficacy relating to the development of medicines
Scientific Advisory Group
Scientific advisory groups (SAG) at the European Medicines Agency (EMA) provide independent recommendations on scientific /technical matters related to medicinal products under evaluation at the EMA, or any other relevant scientific issue. Scientific advisory groups are created by the EMA™s Committee for Medicinal Products for Human Use (CHMP). They consist of experts selected according to the particular expertise required.
Selection bias occurs when there are systematic differences between the comparison groups in a study. For example, differences in clinical signs between the groups might lead to different disease progression or response to treatment between groups, rather than the intervention itself. Proper randomisation and/or blinding have not been achieved, which can affect the statistical analysis and internal validity of the study.
Selection bias is sometimes used to refer to an error in the selection of studies for reviews. Publication bias is a type of selection bias. Confusingly, selection bias is also sometimes used to refer to systematic differences between the study group and the general population. This leads to problems with external validity.
Selective reporting is the reporting of results from only a selection of studies. Selective reporting can lead to publication bias. For example, if a greater proportion of studies with a positive outcome are reported than those with a negative outcome, a review of publications will be biased toward a positive result.
Selective reporting can arise if, for example, an investigator, journal editor, or trial sponsor thinks that negative results (where no effect of a new medicine is found) are uninteresting or unimportant. However, the reporting of negative results adds valuable information to the body of evidence available, and can prevent new unnecessary trials being set up.
Sensitivity (of an assay or test) is the ability of an experiment or trial to detect a difference “ for instance, between two groups of participants receiving different medicines in a clinical trial.