Schizophrenia is a chronic and debilitating psychiatric illness consisting primarily of symptoms such as hallucinations and delusions, also termed as "positive" symptoms. In addition, individuals may experience "negative" symptoms which include loss of sense of pleasure, social withdrawal, impoverishment of thoughts and speech and flattening of affect. According to WHO estimates, schizophrenia affects approximately 24 million people worldwide. 1 The prevalence of schizophrenia varies across the world, within countries, and at the local and neighborhood level. 2,3 The most recent publications estimate that prevalence of schizophrenia ranges from 1.4 to 4.6 / 1000 and the median incidence varies from 0.15 to 0.20 / 1000 population/year 4,5 and it is higher (7 / 1000 population) in
For better understanding about derivation of various parameters related to pharmacokinetics, this model is developed. Animals or human volunteers are not used in this model but the principles used in pharmacokinetic studies in volunteers are incorporated. There is detailed description about setting of the model and derivation of various parameters step by step. An example is followed to illustrate the calculations involved. Possibilities of further extension of model to derive additional parameters and variations are discussed. The experience indicates that the model serves as a good demonstration to undergraduate students and a meaningful experiment for PG-students for learning and as a practical-examination exercise. The purpose of the article is to widen the use of this simple teaching tool at various centers.
Medical devices which are indispensable part of healthcare delivery system may cause serious events for patients and contribute to healthcare costs. The robust materiovigilance programme will lead to improve the safety of patients and users by reducing the reoccurrence of the incidents. Furthermore, the existing incidents advocate continuous monitoring of medical devices in use, in order to protect the patients’ health. Post marketing surveillance of medical devices is done in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched, at Indian pharmacopeia commission to monitor the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient’s safety. This article reviews regulations and guidance documents regarding medical devices focused on post market vigilance framework in India along with measures for robust implementation of the existing programme.
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