Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.
Context:There is scarce data on the prevalence of harm to adolescents from others’ use of alcohol from India.Aims:The aim is to study the prevalence of harm to school students from others’ alcohol use in the district of Ernakulam, Kerala and examines its psychosocial correlates among victims.Settings and Design:This was a cross-sectional survey of 7560 students of the age range of 12–19 years from 73 schools.Materials and Methods:Harm consequent to others’ drinking was assessed using a brief version of the World Health Organization–Thai Health Questionnaire on Harm to Others from Drinking. Standardized instruments were used to assess other measures.Statistical Analysis:The prevalence of various harms was determined. Mixed-effect logistic regression was used to explore the sociodemographic, academic, and psychological factors associated with various types of harms and odds ratios reported.Results:Harm due to others’ alcohol use was reported by 44.5%, frequent harm by 15.7%, psychological harm by 43.3%, physical harm by 9.7%, property harm by 2.9%, and financial harm by 15.4%. Boys reported greater harm than girls. Girls experienced relatively greater harm within the family and boys outside the family. Being older, having a part-time job and urban residence increased the odds of harm. Adolescents reporting harm had higher odds of substance use, psychological distress, suicidality, sexual abuse, and attention-deficit/hyperactivity disorder symptom-counts.Conclusion:The high prevalence of harm from others alcohol use to adolescents with multiple negative impacts underscore the urgent need for public health measures to reduce social costs of alcohol use.
The findings of this study suggest that sleep stages can alter cortical synchrony in patients with JME and focal epilepsy, with NREM IEDs being more synchronized and wake/REM IEDs being less synchronized. Furthermore, it also suggests that AEDs alleviate seizures in PWE by inhibiting cortical synchrony.
Objective: The objective of present investigation was to develop rivastigmine tartrate transdermal film employing factorial design.
Methods:The formulations were designed by Design-Expert software-version10. A series of films were prepared by solvent casting method using polymers, plasticizer, permeation enhancer and other solvents. Transdermal films were evaluated for flatness, drug content, tensile strength, in vitro drug release and ex vivo skin permeation study.
Results:The flatness was found 100% (percentage) for all film formulations. The drug content of transdermal film was found in the range of 96.51±0.2 to 98.81±0.3%. The tensile strength of transdermal film was found in the range of 6.28±0.06 to 11.56±0.03 N/mm 2 (newton/millimeter 2 ) and in vitro drug release at 24 th h (hour) was found in the range of 86.24±0.25 to 96.1±0.48% for various formulations and ex vivo skin permeation study results at 24 th h was found in the range of 85.83±0.74 to 97.36±0.93%.
Conclusion:These results support the feasibility of developing transdermal film of rivastigmine tartrate for human applications. Thus, transdermal delivery of rivastigmine tartrate film is a safe, painless and cost effective drug delivery system for Alzheimer's patients.
Fructooligosaccharide (FOS) has been used in infant formula and conventional foods as prebiotics. Short chain FOS (FOSSENCETM) is produced by a patented process of biotransformation of sucrose by the action of enzyme from live microbial cells, hence toxicology studies were initiated to assess its safety. The objective of the present study was to determine safety of FOSSENCETM in acute, 14-day, and subchronic (90-day) toxicity studies. In acute and 14-day studies, administration of the FOSSENCETM to Wistar rats did not cause any mortality or clinical signs and changes in body weights, feed consumption, and gross pathology at the doses of 2000, 5000, and 9000 mg/kg body weight. In the subchronic (90-day) toxicity study, FOSSENCETM was administered by oral gavage to Wistar rats at the doses of 0, 2000, 5000, and 9000 mg/kg/day for 90 days. No treatment-related clinical signs or mortalities were observed. Similarly, no treatment-related toxicologically or biologically significant changes in body weight, feed consumption, ophthalmological findings, neurological effects, hematology, clinical chemistry, urinalysis, and gross pathological findings were noticed. However, statistically significant increase in weight of cecum (without correlative microscopic change) was noted at all the test item-treated groups in males and females and was considered to be a trophic effect and not a toxic effect in rats.
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