SafetyThe 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(...)
Safety PharmacologySafety 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(...)
Safety specificationThe 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(...)
Sample sizeIn 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(...)
Scale-upIn 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 PartyThe 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(...)
SAWPThe 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(...)
Scientific Advisory GroupScientific 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(...)
SAGScientific 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(...)
Selection BiasSelection 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(...)
