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2022

Vol 4, No 2 (2022): An Investigation of an Extremely Rare Presentation of Gastroschisis Characterised By Many Skeletal Abnormalities, an Imp

Authors: Abhishek Lohakare, Shriraj Kulkarni, Sagar Kolekar

Abstract: Gastroschisis is a rare congenital abdominal wall abnormality that affects the whole thickness of the front abdominal wall. Gastroschisis is one of the most severe types, with a frequency of roughly 1 in 10,000 live births. The deformity is more frequent among young moms under the age of 20. They are often tiny for gestational age and have a high incidence of death. Only 60% make it to the conclusion of the first year. Simple gastroschisis is defined as having an intact intestine, whereas severe gastroschisis has intestinal atresia, perforation, and/or necrosis. It is not usually accompanied with any other congenital abnormalities. We describe a rare instance of gastroschisis with limb abnormalities, kyphosis, talipes equinovarus, imperforate anus, lack of external genitalia, and nipples. This congenitally malformed baby was born at 24 weeks of gestation by a 23-year-old primy and was discovered via ultrasonography.

Keywords: Gastroschisis; Imperforate Anus; Kyphosis; Talipes Equinovarus.

Vol 4, No 2 (2022): The Ergonomics of Telepathological Evaluation of Renal, Liver, and Pancreatic Grafts Using Digital Microscopy in Organ T

Authors: Nima Girawale, Manoj Bhardwaj

Abstract: Introduction: The process of developing a stronger safety culture, error analysis methodologies, and preventative measures begins with a knowledge of the consequences of remote microscopic diagnostics in surgery, particularly in organ transplantation for the remote assessment of grafts. Even in well-organized transplant systems, it is estimated that 8% to 14% of grafts (G) arriving to recipient hospitals are sick, wounded, damaged, or unsuitable for transplantation. Digital microscopy offers information regarding grafts in Organ Transplant (OT) on a microscopic level, which may lead to a change in their care. This strategy reduces the risk of a defective G arriving to the destination hospital for implantation.Aim: To investigate the ergonomics of Digital Microscopy (DM) using virtual slides, as well as Telemedicine Systems (TS) for Tele-Pathological (TPE) assessment of grafts (G) in organ transplantation (OT).Material and Methods: The ergonomics of DM for microscopic TPE of Renal Graft (RG), Liver Graft (LG), and Pancreatic Graft (PG) tissues are investigated using experimental simulation. This related to the ergonomics of digital microscopy for TPE in OT by using the Virtual Slide (VS) method for graft tissue image acquisition, enabling remote diagnosis of probable microscopic inflammatory and/or neoplastic diseases.Experimentation includes the following steps: a. development of an OTE-TS-like Experimental Telemedicine System (Exp.-TS), and b. simulation of TS integration with VS-based microscopic TPE of RG, LG, and PG using DM. Two specialists simulated the DM-based TPE on 238 human Renal Graft (RG), 172 Liver Graft (LG), and 108 Pancreatic Graft (PG) tissues digital microscopic pictures for inflammatory and neoplastic lesions on four electronic spaces of the four employed TS.Results: A statistical analysis of specialists' responses regarding their ability to accurately diagnose diseased RG, LG, and PG tissues on the electronic space among four TS (A,B,C,D) revealed that DM on TS for TPE in OT is elaborated perfectly on the ES of a Desktop, followed by the ES of the applied Exp.-TS. Tablet and Mobile-Phone ES appear to be considerably dangerous for the use of DM in OT (p.001).Conclusion: To achieve the greatest decrease of mistakes and adverse events related to graft quality, it will be necessary to use human factors engineering to procurement, design, audit, and awareness-raising initiatives. As a result, DM in OT will necessitate an investment in new training, personnel, and other modifications to management operations. The simulation of VS-based TPE with DM of RG, LG, and PG tissues after retrieval appears feasible, dependable, and reliant on the size of the electronic space of the used TS, for remote prevention of diseased grafts from being retrieved and/or sent to the recipient hospital, and for post-grafting and pre-transplant planning.

Keywords: Organ Transplantation, Tele-Pathology, Digital Microscopy, Virtual Slides.

Vol 4, No 2 (2022): Thoracic Endovascular Aortic Repair (TEVAR)- A Novel Approach in the Treatment of Descending Aortic Disease

Authors: Prasoon Garg, Amol Khandare, Dr. Yuvraj Kokate

Abstract: TEVAR (thoracic endovascular aortic reconstruction) is becoming more popular in the treatment of descending aortic pathologies such as aneurysms, dissections, and transaction. Hybrid treatments for treating aortic arch disease have been developed, in which key arch arteries are bypassed utilising a number of approaches. Here we present a case of 48 years male, presented with shortness of breath and chest pain for 2 months. A contrast-enhanced computed tomogram of the chest revealed several saccular outpouchings at the distal arch and middescending aorta. He received a hybrid treatment that involved bypassing the Innominate artery to the left carotid and subclavian arteries, followed by TEVAR to cover the whole saccular aneurysm. His surgical phase was uncomplicated, and he is currently doing well.

Keywords: Hybrid surgery, Saccular aneurysm, Thoracic aortic aneurysm

 

Vol 4, No 1 (2022): Systematic Implementation of Quality Management Systems in State-Run Medicine-Control Labs

Authors: Sayali Patil, Shaurya Shete, Jadhav Kamlesh

Abstract: The article examines the regulatory framework in the field of regulating laboratory operations for quality control of pharmaceuticals at the global and national levels. Considering the harmonisation of the new version of ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" and ISO 9001:2015 "Quality management systems. Requirements," the necessity of widespread implementation of the process approach and risk-oriented thinking in laboratory activities has been established. The general techniques to implementing quality management systems (QMS) in pharmaceutical testing laboratories are presented. A example list of QMS procedures of the laboratory for quality control of medicines has been produced, and such processes are recommended to be divided into three groups: management processes, resource provision processes, and major (analytical testing) processes. It is established that these process groups should be defined in the Quality Manual, with a mandated visual depiction of the QMS process model structure and a description of the process interaction conditions. The application of the PDCA Cycle inside each process has been shown to enhance systematic measurement, activity analysis, and the formulation of effective corrective and preventative measures (CAPA). The establishment of effective QMS in state and private laboratories for quality control of pharmaceuticals will aid in reducing the number and significance of inconsistencies and errors in analytical work, as well as providing adequate guarantees for obtaining reliable results, as well as increasing staff awareness of quality management methods and continuous improvement.

Keywords: Laboratory, Quality management system, Process approach, standards, ISO 9001, ISO 17025, PDCA Cycle, medicines, quality control.

Vol 4, No 1 (2022): Dengue: A Serious Threat to Public Health around the World

Authors: Priya Saxsena, Pankhudi Choudhary

Abstract: In recent years, dengue fever cases have been reported from all around the world. Dengue fever is a viral infection that is transmitted to humans by the bite of infected Aedes mosquitos, particularly Aedes aegypti. The goal of this page is to provide information on many aspects of dengue. By reviewing peer-reviewed papers and acquiring access to internationally recognised scientific databases, a bibliographic search was done to retrieve accessible published content (Scopus, PubMed, SciELO, NISCAIR, Google Scholar and WHO Guidelines available during 1994-2016). Overall, 100 papers were thoroughly reviewed, but only 22 research from 1994 to 2016 were chosen for the study. Dengue criteria, transmission, laboratory diagnosis methods, clinical treatment (including a step-by-step approach to dengue management), and vector management are all covered on this page (including biological control). The study's main findings include the recently introduced Caripill tablets and the Dengvaxia immunisation. Caripill tablet has been shown to increase platelet count, which is a big accomplishment. This article will provide a roadmap for clinicians and other healthcare professionals. It will aid in raising public knowledge about dengue. More research on dengue fever is needed.

Keywords: Dengue; Caripil; Aedes aegypti; Dengvaxia; Platelet count;

Vol 4, No 1 (2022): A Review on Hyperuricemia and the Worldwide Risk of Cardiovascular Disease Current Research and Future Preventive Strate

Authors: Arjun Dahal, G. Sivakumar, S. Ramesh Babu

Abstract: Over the last several years, scientific study has focused on the possible significance of hyperuricemia as a cardiovascular risk factor; the major focus has been on persistently elevated plasma uric acid levels. Although some studies have not found a strong link between hyperuricemia and cardiovascular risk, the majority of scientific evidence agrees that hyperuricemia is important in determining cardiovascular events and the development of other risk factors, which are frequently associated with only moderately elevated serum uric acid levels. The pathophysiological mechanisms behind this connection include mostly hyperuricemia-induced endothelial dysfunction, as well as inflammatory and oxidative stress caused by high blood uric acid levels. Early detection, follow-up, and preventative measures, as well as successful hyperuricemia therapy, are especially suggested in patients with additional concurrent cardiovascular risk factors. Urate-lowering medication should aim to achieve a serum uric acid level of less than 6 mg/dL (360 mol/L), while in high-risk individuals, the lowest feasible value of uric acid is preferable.

Keywords: Cardiovascular Disease, Worldwide Risk, pathophysiological Mechanisms, Hyperuricemia Therapy

Vol 4, No 1 (2022): A Review of Information and Prevention of Communicable Diseases

Authors: Dr. Chetan Salekar, Arjun Yadav, Ganesh Ahire

Abstract: In recent decades, natural disasters have killed millions of people, disrupted the lives of nearly one billion people, and resulted in enormous economic compensations. The primary causes of communicable illness in disasters may be categorised into four categories: Among the most prevalent are infections caused by contaminated food and water, respiratory infections, vector and insect-borne illnesses, and infections caused by wounds and trauma. The most prevalent causes of morbidity and death in this situation are diarrheal disease and acute respiratory infections. The purpose of this protocol is to assist the discovery, evaluation, and synthesis of the best available information on the prevention and assessment of the following priority infectious diseases: diarrhoea, hepatitis A and E, leptospirosis, vector-borne illnesses, and wound and injury infections.

Keywords: Communicable Diseases, Vector-Borne Illnesses, Infectious Disease, Economic Compensations

Vol 4, No 1 (2022): A Comprehensive Analysis of the Current State of Generic Pharmaceuticals in India

Authors: Bidisha Chaudhuri, Amit Chattopadhyay

Abstract: Drugs or medications are substances that are used to treat, diagnose, mitigate, or prevent disease. However, it is too costly. Not at all, yet therapy is extremely difficult for poorer and middle-class people due to the high expense of medications. Many people die because they cannot pay the cost of their medications. The introduction of generic drugs into the market resulted in a dramatic shift in the healthcare system, with the market share steadily expanding. The poor and vulnerable elements of society gain since these are genuine, dependable, secure, inexpensive, and available to everybody. There is now an alternative to expensive branded medications. The government of India is taking several initiatives to increase the availability of generic drugs in both rural and urban regions, as well as to educate people about how safe and effective they are in comparison to branded medicines. Many pharmaceutical businesses manufacture generic drugs and distribute them through retail shops. E-pharmacies are also in operation, delivering generic medications to customers' homes. Thousands of Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK) have been established around the country to provide generic medications at a considerably lesser cost. The current paper is based on a research to determine the availability of generic medications through PMBJK, a price comparison of generic and branded medicines, the reasons for the lower price of generic medicines, and locations other than PMBJK where generic medicines are accessible.

Keywords: Pradhan Mantri Bhartiya Janaushadhi Kendra PMBJK, Market share of generic medicines in India, Price comparison of generic and branded medicines.


2021

Vol 3, No 2 (2021): Treating Diseases like Inflammation and Arthritis with Different Biological Extracts to Help the Body

Authors: Rohit singh Dhanwai, Hemant Kumar

Abstract: Inflammation and the arthritis are the two most irremovable diseases which affect human life at the time of old age. Different preventive measures from all parts of the world are taken into consideration, so that effective and constructible care and a balanced medicine could be made against the concerned bodily arrays. As per the allopathic medicines are taken into consideration they furnish some relief, but only up-to the use of the medicines. But nowadays scientists showed their interest towards the utilisation of medicinal plants against almost all types of diseases. Similarly the present study was carried out about the three medicinal plants viz, Artemisia maritima, Capsicum annuum, Juglans regia against inflammation and arthritis. Among the three plants Juglans regia oil was found most effective against inflammation and arthritis followed by capsicum annum. Also among various extracts  of the concerned plants more polar solvents extracts proved to be more effective as compared to less polar solvent extracts.

Keywords:Arthritis, Capsicum Annuum, Juglans Regia, Artemisia Maritima, Inflammation

Vol 3, No 2 (2021): The Use of Natural Remedies for the Treatment of Leukaemia

Authors: Dr. Sharad Tiwari, Devanshu Sharma

Abstract: A case of leukaemia, which was effectively treated using homoeopathic drugs, is described. The treatment regimen includes medications that were prescribed based on the patient's mental symptoms, disease-specific symptoms, and therapy methods. Bone marrow aspiration and trephine biopsy were used to make the diagnosis, which was followed by a regular complete blood count test. The patient has fully recovered from leukaemia and is in good health at this time. Clinical trials involving this homoeopathic therapy procedure are required in order to investigate the therapeutic potential of these drugs in the treatment of leukaemia, according to the authors.

Keywords:Childhood cancer; White blood cells; Juvenile myelomonocytic leukemia

Vol 3, No 2 (2021): Molecular Iodine: A Novel Broad-Spectrum Antiviral Agent against SARS-Cov-2

Authors: Srikanta Akumalla, Hamsini Hari kumar, Maithri D. B, Aditi S. Jois

Abstract: Corona viruses are a group of RNA viruses that cause respiratory infection in mammals and birds. The ongoing COVID-19 pandemic has heightened the battle between humans and viruses. At this time, it is critical for everyone to take precautionary measures in order to avoid becoming infected. Physical barriers, such as masks, PPE kits, and face-shields, as well as maintaining social distance, are recommended. Chemical barriers, such as hand sanitizers, sprays, and hand-washes, are also recommended along with vaccinations. Another lesser-known but well-proven method for combating Covid is to use Iodine as an antiviral agent. Iodine has broad-spectrum disinfectant properties. According to laboratory studies, iodine exposure inactivates the SARS virus within few minutes. Iodine can be taken in the form of Povidone-iodine (PVP-I) gargles or Iodine V (available in the form of Essential Iodine Drops) or the use of molecular iodine (I2) in the form of lotion (I2 Cure). Iodine acts on viruses by damaging viral surface proteins and lipid coating. Free iodine can cause irreversible damage to the virus by degrading viral nucleoproteins, oxidising nucleic acids, and disrupting metabolic pathways. Furthermore, free iodine is an anti-inflammatory agent during viral infections because it scavenges free radicals. Iodine's above action results in the inactivation of the cell/viral particle. Although the use of iodine seems as a promising method of inactivating viruses, the effects of long-term exposure to Iodine is not fully evaluated.

The purpose of this paper is to understand a relatively unknown but well-proven mode of disinfection, namely the use of molecular iodine, against Corona virus.

Keywords: COVID, Molecular Iodine, Antiviral agent, Antimicrobial Agent, SARS-CoV-2

Vol 3, No 2 (2021): Current Therapeutic Options for Parkinson's disease and the Role of Proinflammatory Cytokines

Authors: Priyam Jain, Yogesh Kirar, Sameer Thakur

Abstract: In Parkinson's disease, dopaminergic neurons in the substantia nigra region of the brain gradually degenerate, resulting in a progressive loss of function. Because the origin of this disease is unclear, treatment is symptomatic and ineffective in terms of slowing the progression of the condition. Recent research, on the other hand, has established a clear link between neuroinflammation and proinflammatory cytokines and the pathophysiology of several diseases. A discussion of the relationship between proinflammatory cytokines and the pathophysiology of Parkinson's disease is presented in this paper, which also considers current therapy options that target these pathways.

Keywords: Parkinson's disease; Neurodegenerative disease; Neuroinflammation; Current approaches; Proinflammatory cytokines

Vol 3, No 2 (2021): A Systematic Review on Oral Lichen Planus: Pathogenesis and its Treatment

Authors: Krishna Dhungana, Sunil Gupta, Daisy Arora

Abstract: Oral lichen planus (LIE-kun PLAY-nus) is an ongoing (chronic) inflammatory condition that affects mucous membranes inside your mouth. Oral lichen planus may appear as white, lacy patches; red, swollen tissues; or open sores. These lesions may cause burning, pain or other discomfort. Oral lichen planus can't be passed from one person to another. The disorder occurs when the immune system mounts an attack against cells of the oral mucous membranes for unknown reasons. Symptoms can usually be managed, but people who have oral lichen planus need regular monitoring because they may be at risk of developing mouth cancer in the affected areas. The white, lacy patches may not cause discomfort when they appear on the inside of the cheeks. However, symptoms accompanying red, swollen patches and open sores may include burning sensation or pain. Some factors may increase your risk of developing oral lichen planus, such as having a disorder that lowers your immunity or taking certain medications, though more research is needed. In the present review a brief pathophysiology and different treatment approaches are discussed in brief.

Keywords: Oral Lichen planus, immunity, open sores, corticosteroids, nutraceuticles.

Vol 3, No 1 (2021): Advanced Data Mining Techniques and Their Impact on Enhancing Pharmacovigilance Practices for Improved Drug Safety Monit

Authors: Dr. Rohan Mehta, Dr. Priya Choudhary

ABSTRACT: Pharmacovigilance is a critical aspect of healthcare that focuses on detecting, assessing, and preventing adverse drug reactions (ADRs) to ensure patient safety. With the exponential growth of medical data, traditional methods of monitoring drug safety have become insufficient. Data mining techniques have emerged as powerful tools that can analyze large-scale datasets to identify hidden patterns and potential drug-related risks. This paper explores the application of various data mining methodologies in pharmacovigilance, highlighting their role in signal detection, risk assessment, and predictive analysis. Moreover, it discusses challenges associated with data heterogeneity, privacy concerns, and methodological limitations. The paper also explores the future scope of integrating advanced computational approaches, such as machine learning and artificial intelligence, with pharmacovigilance systems.

KEYWORDS: Pharmacovigilance, Data Mining, Adverse Drug Reactions, Signal Detection, Predictive Analysis, Machine Learning, Drug Safety Monitoring.

Vol 3, No 1 (2021): Sports Medicine as a New Frontier for Ayurveda

Authors: Kavita Gupta, Mahima Sharma

Abstract: Ayurveda, an ancient Indian medical system, is one of the most important systems of alternative medicine. Due to its distinct unmatched concept, it is proven to be highly practical even in the current period of medicine. We can't find any field of current medicine that has explanations of sports medicine from two centuries ago, and the same is true of Ayurvedic literature. However, in this modern era of medicine, the discipline of medicine is becoming increasingly multidisciplinary by combining information from other professions. In contemporary medicine, the area of sports medicine has just recently evolved as a separate department. As a result, Ayurvedic practitioners began to use the term "sports medicine" and chose a number of traditional, time-tested formulas that were discovered to be acceptable for prescription for modern-day sports injuries. They also took many of the formulas and procedures used in many ancient martial arts schools and produced numerous contemporary medicaments based on them. This study tries to describe this new subject by mentioning historic formulations as well as current pharmaceuticals.

Keywords: Ayurveda, Sports medicine, Physical exercises, Rasayana Diet, Ayurvedic Practitioners

Vol 3, No 1 (2021): Formulations of Poly Herbal Gel based Hand Sanitizer

Authors: Sidat Parin S., Ashara S.Jeesha.,Varachia AyshaI., Vanshiya Shivangini K., Unagar Ajay H., Virani G.Smit.

Abstract: The primary mode of transmission of microbes and infections is through the hands. Hand hygiene is thus the most important measure for avoiding the transmission of harmful germs and preventing infections. Hand sanitizer kills hazardous microorganisms on the hands while also preventing scratching, irritation, and dermatitis. The main aim of this research work is to develop a polyherbal hand sanitizer that is both alcohol-based and alcohol-free. Various essential oils, water and IPA, extracts of Neem leaf (Azadiractaindica), Tulsi leaf Ocimum sanctum L.), Kesudo leaf, Orange peel, Pulp of Aloe, were components of the hand sanitizers instead of synthetic ingredients. All of the ingredients have antimicrobial properties and smoothing effects on the hands. Physicochemical parameters such as pH, viscosity, and foam stability were determined along with antibacterial activity of hand sanitizer on selected strains of microorganisms. The findings show that the formulations have strong appearance characteristics, and the sanitizer's overall characterization showed that the formulations have no unpleasant color or odor.

Keywords: Hand sanitizer, Hand hygiene, Essential oils, Plant extracts

Vol 3, No 1 (2021): Determinants Influencing the Relapse of SARS-Cov-2 Infections in COVID-19 Pandemic

Author: Arathi Radhakrishanan, Chanchal Srivastav, Chandresh Sharma, Chanderdeep Tandon, Rajpal Srivatsav

Abstract: The pandemic COVID-19 caused by SARS-CoV-2, has been responsible for millions of deaths, highest in world history in a year. Most countries have been affected by COVID-19 and this viral infection has become a serious threat to public health worldwide. There are many reports indicating the relapse of COVID-19. Millions of people have been infected and recovered from SARS-CoV-2 infection. However, there are ambiguities regarding the immunity elicited by SARS-CoV-2. Numerous cases have been reported worldwide about the relapse and reoccurrence of the disease. This has led to the discussion regarding the immune response and immunity developed after infection. There are multiple factors responsible for the relapse of COVID-19. The relevance of relapse phenomenon cannot be underscored and the factors responsible should be monitored for successfully combating the disease. Hence, the focus should be to understand the relapse phenomenon and various factors responsible for this condition. SARS-CoV-2 is undergoing continuous mutational changes to adapt for higher pathogenicity and rapid transmission. Therefore, there is requisite to understand the relapse mechanism and the factors responsible of COVID-19.

Keywords: COVID-19, Coronavirus, SARS-CoV-2, Immune response, Vaccine, Relapse infection.

 

Vol 3, No 1 (2021): Rosacea: Pathophysiology, Differential Diagnosis and Treatment Modalities

Authors: Varsha Sodhi, Raj Kumar Narang, Daisy Arora

Abstract: Rosacea is a chronic cutaneous inflammatory disease that affects the facial skin. Clinically, rosacea can be categorized into papulopustular, erythematotelangiectatic, ocular, and phymatous rosacea. However, the phenotypic presentations of rosacea are more heterogeneous. Although the pathophysiology of rosacea remains to be elucidated, immunologic alterations and neurovascular dysregulation are thought to have important roles in initiating and strengthening the clinical manifestations of rosacea. In this article, we presented the possible molecular mechanisms of rosacea based on recent laboratory and clinical studies. We have also described the genetic predisposition for rosacea along with its associated diseases, triggering factors, and suggested management options in detail based on the underlying molecular biology. Understanding the molecular pathomechanisms of rosacea will likely aid in better comprehending its complex pathogenesis.

Keywords: Rosacea; Inflammation; cutaneous disorder; Facial erythema; papules


2020

Vol 2, No 2 (2020): Blockchain For Data Integrity in Pharmacovigilance: A Novel Approach to Secure and Transparent Drug Safety Monitoring

Authors: Dr. Raghav Mehta, Dr. Sneha Iyer

ABSTRACT: Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects of pharmaceutical products. The increasing volume of health data, including electronic health records, social media reports, and clinical trial results, demands high levels of data integrity and transparency. Blockchain technology, with its decentralized, immutable, and transparent ledger system, presents a promising solution to improve data integrity in pharmacovigilance systems. This paper explores the potential of blockchain to enhance pharmacovigilance by ensuring secure data sharing, reducing data tampering, and promoting trust among stakeholders. Additionally, challenges in implementing blockchain, such as scalability, privacy, and regulatory compliance, are discussed along with future research directions.

KEYWORDS: Blockchain, Pharmacovigilance, Data Integrity, Drug Safety, Adverse Drug Reactions, Decentralized Systems, Smart Contracts

Vol 2, No 2 (2020): The Impact of Digital Health on Pharmacovigilance

Authors: Dr. Meena Verma, Mr. Ankit Rao

ABSTRACT: Digital health technologies are reshaping the field of pharmacovigilance, introducing advanced tools for detecting, reporting, and preventing adverse drug reactions (ADRs). With the rise of electronic health records (EHRs), mobile health applications, wearable devices, artificial intelligence (AI), and big data analytics, pharmacovigilance is shifting from reactive safety monitoring to proactive, predictive approaches. This paper examines the impact of digital health innovations on pharmacovigilance systems, focusing on benefits, challenges, regulatory considerations, and future directions. It highlights how digital tools enhance patient safety, regulatory compliance, and global collaboration in drug safety monitoring.

KEYWORDS: Digital Health, Pharmacovigilance, Artificial Intelligence, Electronic Health Records, Drug Safety

Vol 2, No 2 (2020): Role of Big Data and Machine Learning in Drug Safety: Transforming Pharmacovigilance for the Digital Era

Authors: Dr. Richa Sharma, Mr. Karan Mehta

ABSTRACT: The integration of big data analytics and machine learning (ML) has revolutionized pharmacovigilance by enabling real-time detection, prediction, and prevention of adverse drug reactions (ADRs). Traditional drug safety monitoring faces challenges such as underreporting, delayed signal detection, and fragmented data sources. Big data platforms consolidate diverse datasets from electronic health records, social media, clinical trials, and wearable devices, while ML algorithms facilitate pattern recognition, risk stratification, and predictive modeling. This paper explores the principles, methodologies, challenges, and regulatory considerations in implementing big data and ML for drug safety monitoring. Tables summarizing applications, benefits, and limitations are included. The adoption of these technologies promises enhanced patient safety, optimized therapeutic interventions, and data-driven decision-making in pharmacovigilance.

KEYWORDS: Pharmacovigilance, Big Data, Machine Learning, Adverse Drug Reactions, Drug Safety, Predictive Analytics

Vol 2, No 2 (2020): Quality Assurance Audits in Pharmaceutical Industries: Ensuring Compliance and Safety

Authors: Dr. Meera Sharma, Mr. Arjun Verma

ABSTRACT: Quality assurance (QA) audits in pharmaceutical industries are integral to ensuring compliance with regulatory standards, maintaining product quality, and safeguarding patient safety. Audits provide a systematic evaluation of manufacturing processes, documentation, and operational procedures. This paper discusses the objectives, methodologies, challenges, and significance of QA audits in pharmaceutical industries. Emphasis is placed on the role of audits in Good Manufacturing Practice (GMP) compliance, continuous process improvement, and risk mitigation. Tables summarizing audit types and common findings are included. Through effective QA audits, pharmaceutical companies can achieve regulatory compliance, maintain high-quality standards, and ensure safe and effective medicines for public use.

KEYWORDS: Quality Assurance, Audits, Pharmaceutical Industry, GMP Compliance, Risk Mitigation, Process Improvement

Vol 2, No 2 (2020): Pharmacovigilance For Herbal and Traditional Medicines: Ensuring Safety in Complementary Therapies

Authors: Dr. Asha Mehta, Mr. Ravi Kumar

ABSTRACT: The use of herbal and traditional medicines (HTMs) has seen a rapid global increase, driven by cultural practices and a preference for natural therapies. While often perceived as safe, these medicines can cause adverse reactions, interactions with conventional drugs, and may be contaminated with adulterants or heavy metals. Pharmacovigilance in HTMs is critical for detecting, assessing, and preventing these risks while ensuring patient safety. This paper explores the principles, methodologies, challenges, regulatory frameworks, and modern tools employed in the pharmacovigilance of herbal and traditional medicines. Emphasis is placed on integrating real-world data, promoting standardization, and strengthening safety monitoring to enhance public confidence in complementary therapies.

KEYWORDS: Herbal Medicines, Traditional Medicine, Pharmacovigilance, Adverse Reactions, Safety Monitoring

Vol 2, No 1 (2020): Ethical Considerations in Pharmacovigilance Studies: Balancing Patient Safety and Research Integrity

Authors: Priya Nair, Vikram Desai

ABSTRACT: Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring adverse drug reactions (ADRs) and assessing therapeutic outcomes. Ethical considerations in PV studies are essential to protect patient rights, ensure data integrity, and maintain public trust in healthcare systems. This paper explores the ethical principles guiding PV, including informed consent, confidentiality, transparency, and equitable access to information. Challenges such as reporting bias, conflict of interest, and balancing patient confidentiality with public health obligations are discussed. Tables illustrate ethical frameworks, key PV responsibilities, and strategies to address ethical dilemmas. The paper emphasizes the integration of ethical guidelines, regulatory compliance, and continuous education to promote responsible pharmacovigilance practices.

KEYWORDS: Pharmacovigilance, Ethics, Adverse Drug Reactions, Informed Consent, Confidentiality, Patient Safety, Regulatory Compliance.

Vol 2, No 1 (2020): A Comprehensive Literature Review of Coronavirus Pandemic: Therapeutic Options and Possible Lessons from SARS-CoV

Authors: P. S. Meher, Dr. J.R. Rao

Abstract: There are new public health emergencies debilitating the world with the spread of the coronavirus disease in 2019. This presents an inventive challenge to identify useful drugs for therapy. A new coronavirus was found in China, Wuhan city, in December 2019. A causative agent earlier termed COVID-19 by WHO. It affects the lower respiratory tract and explicit as pneumonia in humans. The disease is transferred by inhalation or in contact with infected surfaces. The evaluation and exposure to the pathogenic organism period of the virus is between 2 to 14 days. The common symptoms observed usually are cough, fever, fatigue and sore throat, among others. The number of people is asymptomatic. The present review includes in detail information of virus, its epidemiology, symptoms, diagnostic tests, prevention, some useful therapies and drugs which may be effective in treatment.

Keywords: Covid-19, epidemiology, pathogenesis, favipiravir, unani system


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