What is the advantage of spontaneous reporting of adverse drug reactions: (1)Captures only suspected adverse drug reactionsIt gives pregnancy outcome of a medicineProvides denominator information and allows calculation of incidence rates of adverse drug reactionsIt allows continual monitoring for the length time that the medicine is commercially availableIt is new to healthcare providers and pharmacovigilance centres
Read DetailsA human clinical trial is defined as: (1)1. An idea which is suggested as a possible explanation for a particular situation in humans, but which has not yet been proved to be correct2. A study performed to investigate the safety or efficacy of a medicine in humans3. The practice of monitoring the safety of a medicine in humans after it has been released on the market4. The evaluation of the likelihood that a medicine was the causative agent of an observed adverse drug reaction in humans5. A detailed record of all relevant data associated with the use of a medicine in a patient
Read DetailsA 35 year old major depressive disorder (MDD) patient started on sertraline 2 weeks ago presents with restlessness, nausea, headaches and anorexia. His initial MDD symptoms persist. The reasons for this patient’s clinical picture include: (1)Sertraline is not the first line treatment for MDDIt is too early to expect improvement in the patient’s MDD symptomsThe treatment is incorrect and should therefore be changedThe restlessness, nausea, headaches and anorexia certainly represent MDD symptomsSertraline should be substituted with diazepam
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