A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy

A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.

Time to put a spotlight on out-patient chronotherapy for depression

Summary The challenge of identifying efficacious out-patient treatments for depression is amplified by the increasing desire to find interventions that reduce the time to sustained improvement. One potential but underexplored option is triple chronotherapy (TCT). To date, use of TCT has been largely restricted to specialist units or in-patients. Recent research demonstrates that it may be possible to undertake sleep deprivation in out-patient settings, raising the possibility of delivering TCT to broader populations of individuals with depression. Emerging evidence suggests that out-patient TCT is a high-benefit, low-risk intervention but questions remain about how to target TCT and its mechanisms of action. Like traditional antidepressants, TCT probably acts through several pathways, especially the synchronisation of the ‘master clock’. Availability of reliable and valid methods of out-patient measurement of intra-individual circadian rhythmicity and light exposure are rate-limiting steps in the wider dissemination of TCT.

Effective Role of Village Health Volunteers (VHVs) in Response to the COVID-19 Pandemic Emergencies in Thailand

This study included a discussion of the critical role VHVs played in the control, prevention, and monitoring of the Covid-19 pandemic in Thailand, as well as a review of related literature, with 11 of 59 topics chosen. The purpose of this study was to investigate and improve VHV competence in the control, prevention, and monitoring of the Covid-19 pandemic. The outcomes of the study indicated that VHVs were important in efficiently managing, preventing, and monitoring the Covid-19 pandemic from 2020 until the present. As a result, in addition to maximizing the potential of VHVs, it is important to be varied, knowledgeable, and up to date on current events. However, the most cost-effective utilization of resources is referred to as "Sufficiency Healthcare, High Benefit, Most Economical" when utilizing the concepts of sufficiency economics.

Towards reliable in vitro models – New bi-compartmental platforms for replicating tissue barriers

In vitro cell cultures represent a widespread methodology for pathophysiology studies with a high benefit/cost ratio. We have developed and are validating TToP, a novel, versatile, and scalable culture system allowing compartmentalized cell/tissue cultures with the aim of mimicking the human pathophysiological microenvironment of tissue barriers.

Hyperprogressive Disease After Combined Anti-PD-L1 and Anti-CTLA-4 Immunotherapy for MSI-H/dMMR Gastric Cancer: A Case Report

Immune checkpoint inhibitors (ICI) have been developed in gastric adenocarcinomas and approved in first-line metastatic setting (in combination with chemotherapy) as well as in pretreated patients. Microsatellite instability-high (MSI-H) tumors are predicted to derive high benefit from ICI but data in gastric locations are limited. Here, we describe the case of a 68-year old patient with stage IV MSI-H gastric adenocarcinoma, referred to our center to receive immunotherapy after failure of standard of care (surgery with perioperative platin-based chemotherapy and paclitaxel plus ramucirumab at disease progression). The patient received one injection of durvalumab and tremelimumab and was hospitalized eighteen days after because of occlusive syndrome. The CT scan showed hyperprogression of the lymph nodes and hepatic lesions, compressing the gastric stump. He died few days later. Molecular analyses did not explain this outcome. To our knowledge, this is one of the first reported cases of hyperprogressive disease after combined ICI for a patient with MSI-H tumor. We review the potential causes and discuss the emerging literature regarding predictive factors of hyperprogression in the particular subset of MSI-H patients. If some data were available in retrospective studies, validation of strong predictive factors is needed to avoid such dramatic evolutions.

The impact of telemedicine on the quality and satisfaction with the health care provided during the COVID-19 pandemic in the field of pediatrics with special reference to the surgical professions

The COVID-19 pandemic has forced healthcare systems around the world to adopt telemedicine at an unprecedented rate. Visits to telemedicine have increased to provide access and maintain continuity of care. Internet access has almost become a necessity, and new technologies allow for the easy flow of data from patient to doctor and vice versa. Doctors of all specialties were forced to adapt to the pandemic and emerging conditions. The provision of surgical services and the learning ability of surgeons are particularly disrupted, and the pediatric surgical community is not exempt. During the pandemic, telemedicine proved to be a viable and safe technique for providing health services. In an environment of a health system that is constantly facing a shortage of resources, effective telemedicine placement can come with a high benefit-cost ratio and quality of care, while ensuring patient satisfaction.

Environmental Degradation due to Tobacco Cultivation in Northern Bangladesh

A field study was conducted in Northern Bangladesh, Rangpur district to observe the impact of tobacco cultivation on the environment as well as to characterize contributing factors motivating tobacco cultivation. Information was collected from the tobacco cultivators by a questionnaire survey that was conducted in four mostly tobacco cultivated upazilas, namely Badargonj, Taragonj, Rangpur Sadar, Gangachara of Rangpur district. Information from non-tobacco cultivators was also collected from Mithapukur Upazila. Survey findings revealed that 62.16% of respondents believed that soil productivity is decreasing in the tobacco field and 70.27% of tobacco farmers were using more chemical fertilizer per year than the previous years. More than half (54.05%) of respondents reported that tobacco is replacing native food crops. Moreover, 51.30% of tobacco farmers were facing various health hazards due to tobacco cultivation. The present study also investigated that 97.14% of farmers got a high benefit along with 89.19% of respondent’s availed organizational support from tobacco marketing companies. The overall satisfaction rate with the price was 80.56%, which was the main contributory factor for tobacco cultivation in the study area. The survey results also identified that farmers from Mithapukur Upazila gave up tobacco cultivation due to health hazards and unnecessarily underestimating the grade of tobacco leaf by the buyer company. The Dhaka University Journal of Earth and Environmental Sciences, Vol. 9(2), 2020, P 19-26

Impact of front line demonstration of chickpea (JG 63) in Chhatarpur district of Madhya Pradesh, India

The present investigation was carried out at the adopted villages of Krishi Vigyan Kendra, Chhatarpur during 2017-18 to demonstrate the improved variety JG 63 with the scientific package and practices to improve the production of chickpea. The treatment comprised of scientific package of practices (Improved variety JG 63 + seed treatment with Carbendazim 3g/ kg of seed and seed inoculation with Rhizobium and PSB culture each @ 10 g/ kg of seed + soil test value based fertilizer application + line sowing + adoption of IPM technique). The demonstration plot exhibited higher yield as compared to farmers plot. An average yield of chickpea in the demonstrated plot was 18.74 q/ha as compare to farmers practices 14.16 q/ha in the three years of pooled data. The improved technology gives the higher return with the high benefit cost ratio as farmer’s practices. The observed extension gap, technology gap and technology index were 4.58 q/ha, 1.26 q/ha and 6.30%, respectively. The improved variety with scientific package of practices and technical guidance contributed to increase production of chickpea and profitability of the farmers of the district.

From Mesenchymal Stromal/Stem Cells to Insulin-Producing Cells: Immunological Considerations

Mesenchymal stem cell (MSC)-based therapy for type 1 diabetes mellitus (T1DM) has been the subject matter of many studies over the past few decades. The wide availability, negligible teratogenic risks and differentiation potential of MSCs promise a therapeutic alternative to traditional exogenous insulin injections or pancreatic transplantation. However, conflicting arguments have been reported regarding the immunological profile of MSCs. While some studies support their immune-privileged, immunomodulatory status and successful use in the treatment of several immune-mediated diseases, others maintain that allogeneic MSCs trigger immune responses, especially following differentiation or in vivo transplantation. In this review, the intricate mechanisms by which MSCs exert their immunomodulatory functions and the influencing variables are critically addressed. Furthermore, proposed avenues to enhance these effects, including cytokine pretreatment, coadministration of mTOR inhibitors, the use of Tregs and gene manipulation, are presented. As an alternative, the selection of high-benefit, low-risk donors based on HLA matching, PD-L1 expression and the absence of donor-specific antibodies (DSAs) are also discussed. Finally, the necessity for the transplantation of human MSC (hMSC)-derived insulin-producing cells (IPCs) into humanized mice is highlighted since this strategy may provide further insights into future clinical applications.