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537 articles for “regulatory”
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Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing
Abstract: Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper submission (Common Technical Document), following sign-off by the International Conference on Harmonization Steering Committee of the eCTD Specification document at Step 4. It is …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 1–16 Read article
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A Study on Nutraceutical Products in India: Need of Harmonization in Global Scenario
Abstract: AbstractDuring the study of regulatory guidelines for nutraceuticals and functional foods in India, it was noted that introduction of FSS act in 2006 was a major milestone in integrating of different food laws in India. The FSS act, replaced diverse local laws (such as PFA act. Essential commodity act etc.), post which the Indian regulatory structure of food products has meaningfully progressed. During this journey, the functional food and nutraceutical …
Published in Research & Reviews: A Journal of Pharmacognosy · Vol. 9, Issue 3, 2022 · pp. 1–11 Read article
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Bioremediation of TPH in Petroleum HydrocarbonContaminated Clay Soil with an Emerging Nutrient (Solpawa SBR-X TM)
Abstract: This research focuses on the bioremediation of total petroleum hydrocarbons (TPH) in petroleum hydrocarbon contaminated clay soil with an emerging nutrient (Solpawa SBR-XTM). A laboratory experiment was set up and successfully carried out in order to monitor TPH concentration among the various reactors (T1, T2, T3, and T4). This process was monitored for 7 days, 12 days, 22 days, 32 days, 42 days, and 52 days, respectively, for reactors 1, …
Published in International Journal of Pollution: Prevention & Control · Vol. 1, Issue 1, 2023 · pp. 9–16 Read article
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Risk & Opportunities in Development of new Drugs: A New Perspective
Abstract: The procedures of drug discovery and development are briefly described in this article. Our goal is to assist researchers whose work may be pertinent to the discovery and/or development of new drugs in framing their research reports in a way that appropriately situates their findings within the drug discovery and development process and supports the efficient translation of preclinical research to humans. One overarching theme of our article is the …
Published in Recent Trends in Infectious Diseases · Vol. 1, Issue 2, 2024 · pp. 19–28 Read article
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Horizon Scanning and Early Assessment of Health Technologies for the Treatment of Orphan Diseases
Abstract: The theoretical foundations and regulatory framework of the processes of the formation of an effective health technology assessment (HTA) system at the early stages of the life cycle of medicines are analyzed in the article. Particular attention is paid to horizon scanning (HS) and early assessment of expensive innovative drugs utilized for treating rare diseases. In order to inform policymakers, purchasers, and providers (to prioritize MT research, financial, and operational …
Published in International Journal of Brain Sciences · Vol. 1, Issue 1, 2024 · pp. 32–39 Read article
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Understanding Significance, Challenges and Barriers in Home-Based Medical Care – A Thematic Review of Literature
Abstract: Home-based medical care (HBMC) is emerging as a cornerstone of modern healthcare, offering a pragmatic solution to the evolving needs of patients. This form of care, which delivers personalized and patient-centric services, catering to individual needs within the familiar environment of their homes, is gaining traction for its ability to improve patient outcomes while simultaneously reducing healthcare costs. This thematic review of the literature aims to shed light on the …
Published in Research and Reviews : A Journal of Life Sciences · Vol. 14, Issue 1, 2024 · pp. 66–71 Read article
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Gene Editing and Its Implications for Animal Health
Abstract: Gene editing technologies, particularly CRISPR/Cas9, have revolutionized the field of veterinary medicine, offering unprecedented opportunities for precise genetic manipulation in animals. This review explores the potential applications of gene editing in enhancing animal health, focusing on disease resistance, breeding programs, and the associated ethical considerations. Beginning with an overview of gene editing techniques, we discuss the utility of CRISPR/Cas9 in targeted genetic modifications and compare its advantages and limitations relative …
Published in Research and Reviews : Journal of Veterinary Science and Technology · Vol. 13, Issue 1, 2024 · pp. 13–17 Read article
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Bacteriophage Therapy in Dairy Farming: A Potential Alternative to Antibiotics
Abstract: The widespread use of antibiotics in dairy farming to control bacterial infections has led to significant challenges, including the emergence of antibiotic-resistant bacteria and concerns over antibiotic residues in milk. Consequently, there is an increasing demand for alternative approaches to control bacterial infections in dairy cattle. One promising solution is bacteriophage therapy, which uses viruses that selectively infect and destroy bacteria. As a result, the need for new strategies to …
Published in Research and Reviews : Journal of Dairy Science and Technology · Vol. 13, Issue 2, 2024 · pp. 1–5 Read article
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Nanotechnology in Medical Applications: A Study
Abstract: In the field of medicine, nanotechnology has a wide range of applications that are both transformational and expansive. These apps provide solutions which have an opportunity to significantly enhance the outcomes of treatment and to provide better care for patients. The potential benefits are enormous, ranging from the delivery of drugs in a targeted manner to the development of sophisticated diagnostics and regenerative medicine. The incorporation of nanotechnology into clinical …
Published in Nano Trends – A Journal of Nano Technology & Its Applications · Vol. 26, Issue 2, 2024 · pp. 1–11 Read article
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SiRNA-Based Multivalent Vaccines: A Systematic Review of Potential Risks, Benefits, and Future Applications
Abstract: Background: Small interfering RNA (SiRNA) technology represents a promising innovation in vaccine development, especially for multivalent vaccines that can target multiple pathogens or antigenic variants simultaneously. siRNA-based vaccines offer a unique mechanism to induce specific immune responses, presenting an adaptable and potentially powerful tool for tackling infectious diseases and cancer. Methods: This systematic review synthesizes recent studies on siRNA multivalent vaccines, focusing on their immunogenicity, safety, and effectiveness. We reviewed …
Published in International Journal of Vaccines · Vol. 2, Issue 1, 2025 · pp. 43–49 Read article
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Super Built-Up Area: Examining Its Role in Real Estate Development and Urban Planning Strategies
Abstract: The concept of Super Built-Up Area (SBA) has become pivotal in contemporary real estate development and urban planning strategies. Defined as the total area encompassing the built-up area of an apartment along with common areas like corridors, staircases, and amenities shared among residents, SBA influences both the economic viability of real estate projects and the spatial dynamics of urban landscapes. This study investigates the multifaceted role of SBA in shaping …
Published in International Journal of Urban Design and Development · Vol. 2, Issue 2, 2024 · pp. 01–15 Read article
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Blockchain Technology and Inclusive Financial Systems in the Global South
Abstract: This paper explores how blockchain technology can promote financial inclusivity by providing decentralized, transparent, and secure financial services, particularly in the Global South, where conventional banking systems are frequently insufficient. Through a blend of literature review and empirical analysis, we assess blockchain's role in expanding financial access, using case studies from several developing nations. Our results reveal a promising potential for blockchain to improve financial inclusion, although obstacles such as …
Published in International Journal of Mobile Computing Technology · Vol. 2, Issue 2, 2024 · pp. 17–23 Read article
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The implementation of the food quality protection act (FQPA) in increasing the safety standards for new pesticides used on foods
Abstract: This paper examines the Food Quality Protection Act (FQPA) and its impact on enhancing safety standards for pesticides used on food in the United States. Initially, the study explores the Delaney Clause—a strict standard prohibiting carcinogenic food additives—which FQPA replaced with a more flexible "reasonable certainty of no harm" criterion. This shift allows the Environmental Protection Agency (EPA) to assess pesticide risk with consideration of potential benefits, even if a …
Published in Research and Reviews: A Journal of Toxicology · Vol. 14, Issue 3, 2024 · pp. 41–51 Read article
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Emerging Trends in Drones across Multiple Sectors
Abstract: Drones, also known as unmanned aerial vehicles (UAVs), have become increasingly popular for their adaptability, affordability, and advanced functionalities. Originally developed for military purposes, they are now widely utilized across diverse sectors such as agriculture, filmmaking, and search and rescue missions. The impact of drones has been significant in various domains, such as reducing human casualties, providing more accurate information, increasing efficiency and cost reduction, and improving crop yields. Nonetheless, …
Published in International Journal of Mechanical Dynamics and Systems Analysis · Vol. 2, Issue 2, 2024 · pp. 29–35 Read article
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Antibiotics in the Modern Era: Challenges, Misuse, and the Fight Against Resistance
Abstract: Overuse and inappropriate use of antibiotics in human medicine, agriculture, and environmental pollution. It is one of the biggest public health risks of the 21st century. The discovery of new antibiotics slowdown and the emergence of multidrug-resistant (MDR) microorganisms has highlighted the urgent need to Creative approaches to fighting opposition. This review explores the current challenges in antibiotic use, the factors driving resistance, and the strategies being implemented to address …
Published in International Journal of Antibiotics · Vol. 2, Issue 1, 2025 · pp. 57–70 Read article
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Phytomedicine in 21st century: challenges, innovations & future directions
Abstract: Phytomedicine, the use of plant-derived substances for therapeutic purposes, has experienced significant advancements and challenges in the 21st century. This review explores the current state of phytomedicine, highlighting its advantages, such as natural ingredients, fewer side effects, and cultural acceptance, as well as its disadvantages, including variable quality, lack of standardization, and limited research. The challenges faced by phytomedicine are discussed, focusing on issues of standardization, regulatory discrepancies, scientific evidence …
Published in International Journal of Tropical Medicines · Vol. 2, Issue 1, 2025 · pp. 86–95 Read article
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Homeopathy: A Comprehensive Review of Efficacy, Mechanisms, and Controversies
Abstract: Homeopathy is a widely used alternative medical system based on principles established by Samuel Hahnemann, including “like cures like” and potentization Despite its popularity, homeopathy remains controversial due to the highly diluted nature of its remedies, which often contain no detectable molecules of the original substance. This article provides a comprehensive review of the clinical efficacy, proposed mechanisms, and ongoing controversies surrounding homeopathy Clinical studies yield mixed results, with some …
Published in Research & Reviews : A Journal of Unani, Siddha and Homeopathy · Vol. 12, Issue 1, 2025 · pp. 25–32 Read article
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From Clinic Formulation to Development of Acebrophylline
Abstract: Acebrophylline, a commonly utilized bronchodilator with anti-inflammatory properties, has become a key therapeutic option for managing respiratory conditions like asthma, chronic obstructive pulmonary disease (COPD), and chronic bronchitis. This review explores the journey of Acebrophylline from its clinic formulation to its development and commercialization, focusing on the key aspects of formulation strategies, pharmacological properties, and regulatory considerations. The drug’s dual mechanism of action, which involves both bronchodilation and anti-inflammatory effects, …
Published in Research and Reviews: A Journal of Pharmacology · Vol. 15, Issue 1, 2025 · pp. 35–48 Read article
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Data-Driven Predictive Analytics and Decision- Making in FinTech Using MongoDB and High-Throughput Data Pipelines
Abstract: This paper examines the implementation of MongoDB and high-throughput data pipelines within the financial technology (FinTech) sector to drive data-informed predictive analytics and decision-making. The study focuses on the architectural components, scalability, and challenges of integrating NoSQL databases into real-time data ingestion and analytics pipelines. The transformative potential of these technologies in modern financial systems is highlighted through practical use cases such as fraud detection, credit scoring, and personalized financial …
Published in International Journal of Algorithms Design and Analysis Review · Vol. 3, Issue 1, 2025 · pp. 1–15 Read article
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Ensuring Data Traceability Across Multiple Cloud Environments
Abstract: This study investigates the challenges and solutions for ensuring data traceability across multiple cloud environments. With organizations' increasing reliance on cloud infrastructure, maintaining data traceability is crucial for compliance, data integrity, and secure data management. The diversity of cloud systems, spanning public, private, and hybrid models, introduces complexities in tracking data lineage, access, and movement. This study delves into multi-cloud strategies' technical and operational hurdles, such as varying data formats, …
Published in International Journal of Data Structure Studies · Vol. 3, Issue 1, 2025 · pp. 08–22 Read article