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25 articles for “FDA”
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FDA Drug Approvals 2024: A Comprehensive Review
Abstract: The year 2024 has been pivotal for the pharmaceutical industry, with the U.S. Food and Drug Administration (FDA) granting approval to a diverse array of new drugs. These approvals highlight significant strides in therapeutic innovation, targeting a spectrum of diseases from rare genetic disorders to prevalent chronic conditions. This article provides a detailed examination of the FDA-approved drugs of 2024, focusing on their therapeutic indications, mechanisms of action, and the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 28–46 Read article
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Nanotechnology-Driven Drug Delivery: A Comprehensive Review of Current Trends and Future Directions
Abstract: Nanotechnology has revolutionized drug delivery systems, offering profound advancements in precision, efficiency, and targeted therapeutic interventions. This review examines the revolutionary influence of nanotechnology on medical therapies, focusing on advancements, such as precise drug delivery, improved solubility, and responsive treatment systems. These advancements have significantly improved treatment efficacy and minimize side effects, particularly in oncology and chronic disease management. The development of nanoparticles designed for specific cell targeting and environmental …
Published in Journal of Nanoscience, NanoEngineering & Applications · Vol. 15, Issue 1, 2025 · pp. 24–46 Read article
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Uncovering the Comparative Efficacy of Antiviral Drugs and Caricapapaya Phytocompound as VP2H inhibitors in Ebola virus: An Insilico Molecular Docking Analysis
Abstract: The Ebola virus is a fatal disease that transmits from wild animals to humans. Infected individuals' body fluids such as spit, blood, perspiration, faeces, blood, saliva, breast milk, sperm, or fomites can transmit Ebola. Adhesion to cell membranes and penetration into the host organism are essential aspects in viral growth. The presence of VP24, as well as nucleoproteins and structural proteins, is necessary for nucleocapsid formation and integration. The inhibition …
Published in International Journal of Bioinformatics and Computational Biology · Vol. 1, Issue 2, 2023 · pp. 62–78 Read article
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Molecular Docking Evaluation of Cedrus deodara Secondary Metabolites as a Potent Anti-ovarian Cancer Agent
Abstract: Objective: According to the statistics for the year 2022 it was seen that cancer total cases is 14,61,427. After breast cancer, ovarian cancer is the second most frequent cancer among women. The estrogen receptor (PDB ID: 1X7E), progesterone receptor (PDB ID: 1A28), and Phosphoinositide 3-kinases (PDB ID: 4FJY) can be considered as target protein for ovarian cancer. The plant Cedrus deodara and its phytochemicals were chosen in this study to …
Published in International Journal of Molecular Biotechnological Research · Vol. 1, Issue 1, 2023 · pp. 77–93 Read article
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Regulations for Toothbrushes: A Comparative Study Between India, the US, Europe, and Australia
Abstract: Toothbrushes are essential tools for maintaining oral hygiene, making their regulation vital for consumer safety and health efficacy. This article presents a comparative analysis of toothbrush regulations in India, the United States, Europe, and Australia, highlighting the unique frameworks each region has developed to address manufacturing, distribution, and marketing challenges. In India, the Bureau of Indian Standards (BIS) and the Food Safety and Standards Authority of India (FSSAI) set safety …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 1–6 Read article
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A Research on the Additives and Regulatory Requirements for Pediatric Formulation
Abstract: These days, pediatric considerations are incorporated early on in the creation of new medications. The guidelines and policies of European drug regulatory bodies served as the foundation for our investigation. The review comprehensively outlines excipients commonly found in pediatric medicine formulations. It identifies potentially harmful compounds flagged by scientific literature, stressing the necessity of rigorous safety checks, often involving toxicity studies. Excipients included in pediatric databases, like the STEP database, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 28–45 Read article
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Advanced Security Mechanisms for Protecting Mobile Devices: A Comprehensive Analysis of Threats and Counter Measures
Abstract: The digitization of clinical care has led to significant advancements in medical devices and telemetry, fundamentally transforming the healthcare landscape. These innovations have enhanced the quality of patient care by enabling more accurate diagnoses, real-time monitoring, remote consultations, and increased transparency in clinical workflows. As a result, modern medical practices have become more efficient, data-driven, and patient-centric. Devices such as infusion pumps, pacemakers, ventilators, and wearable monitors now rely heavily …
Published in Trends in Opto-electro & Optical Communication · Vol. 15, Issue 3, 2025 · pp. 24–31 Read article
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Innovations in Oral Drug Delivery: Challenges and Opportunities
Abstract: The advancement of novel drug manufacturing technologies offers immense opportunities for innovation but brings regulatory complexities that must be addressed to ensure successful implementation. Early and frequent collaboration with the FDA is fundamental for overcoming these challenges. The establishment of the FDA’s Emerging Technology Team has been pivotal in fostering open dialogue, brainstorming, and feedback between regulators and innovators, reducing the likelihood of unexpected setbacks that could jeopardize projects. Mechanisms …
Published in Trends in Drug Delivery · Vol. 12, Issue 1, 2025 · pp. 31–43 Read article
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Extrapolations of Periwinkle Secondary Metabolites as Multitarget Inhibitor of Breast Cancer Proteins
Abstract: Objective: Breast cancer is considered one of the most common and dangerous forms of cancer. It is a significant public health issue on a global scale. The study estimates that 10.0 million people will die from cancer this year, and 19.3 million people will develop the disease overall (BC). In this computation approach, nowadays emphasizes new drug discovery, the target protein epidermal growth factor receptor (EGFR) (5UGB), estrogen receptor (ER) …
Published in International Journal of Biochemistry and Biomolecule Research · Vol. 1, Issue 1, 2023 · pp. 36–49 Read article
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Data Integrity Best Practices in Pharmaceutical Quality Assurance: A Thorough Review
Abstract: Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 22–30 Read article
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Computational Identification of Antigenic Proteins and Epitopes in Hantavirus sp. for Drug Repurposing
Abstract: Hantavirus is an emerging virus that spreads from animals to humans and can cause serious illnesses like hantavirus pulmonary syndrome (HPS) and hemorrhagic fever with renal syndrome (HFRS). there are no FDA-approved treatments available for these diseases. This study explores in-silico drug repurposing as a strategy to identify potential therapeutic candidates. The physicochemical, secondary structure, antigenicity, and post-translational modification analysis of hantavirus proteins – specifically the glycoprotein precursor, N protein, …
Published in International Journal of Molecular Biotechnological Research · Vol. 3, Issue 1, 2025 · pp. 20–26 Read article
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Computational Investigation of Phytochemicals Targeting AKT1 for Major Depressive Disorder: A Molecular Docking and ADMET Study
Abstract: Major depressive disorder (MDD) is a prevalent neuropsychiatric condition affecting approximately 280 million individuals worldwide, with women exhibiting a 50% higher likelihood of diagnosis than men. Despite significant advancements in treatment, MDD remains a chronic and relapsing disorder, necessitating the exploration of novel therapeutic interventions. This study focuses on the AKT1 gene, a key player in neuropsychiatric disorders, and investigates its interactions with natural phytochemicals as potential alternatives to conventional …
Published in Research and Reviews : Journal of Computational Biology · Vol. 14, Issue 2, 2025 Read article
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Emerging Therapies for Diabetes Mellitus: Efficacy and Safety of USFDA-Approved Drugs and Late-Stage Clinical Trials
Abstract: This review provides a comprehensive analysis of drugs approved by the U.S. Food and Drug Administration (USFDA) for managing diabetes mellitus (DM) from 2013 to 2022, including emerging treatments from phase 3 clinical trials during this period. Over the past decade, the treatment landscape for diabetes has evolved significantly, with new therapies not only improving blood sugar control but also targeting broader health outcomes like heart and kidney health. In …
Published in International Journal of Toxins and Toxics · Vol. 2, Issue 2, 2025 · pp. 11–23 Read article
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Integrative Network Biology Analysis of GSE6011 Uncovers Molecular Signatures in Duchenne Muscular Dystrophy
Abstract: Duchenne muscular dystrophy (DMD) is a rare, severe neuromuscular disorder demonstrated by progressive skeletal muscle deterioration and premature mortality. Despite advances in supportive care, no definitive cure exists, highlighting the need to explore novel molecular targets. The current study aimed to uncover key dysregulated genes and molecular pathways in DMD through a dataset-specific network biology approach. Publicly available microarray data (GSE6011) from DMD quadriceps muscle biopsies of 22 patients and …
Published in Research and Reviews : Journal of Computational Biology · Vol. 14, Issue 3, 2025 · pp. 36–48 Read article
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In-Silico Repurposing of Antipsychotic Drugs Against Novel Protein Targets in Multidrug-Resistant Mycobacterium tuberculosis
Abstract: Multidrug-resistant TB is a growing worldwide health concern, particularly in high-burden areas. Resistance to frontline drugs like isoniazid and rifampicin is caused by mutations in key Mycobacterium tuberculosis proteins. Given the difficulty of developing new antibiotics, medication repurposing offers a good alternative. The potential use of molecular docking to target resistance-associated TB proteins with FDA-approved antipsychotic drugs is investigated in this work. Three proteins were selected: InhA (PDB ID: 5W07), …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 13, Issue 1, 2026 · pp. 49–63 Read article
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Pharmacological Review On Enzalutamide
Abstract: A key therapeutic option in the treatment of prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC), is Enzalutamide, a second-generation anti androgen drug. Enzalutamide, discovered by Charles Sawyer and Michael Jung at the University of California, Los Angeles, was developed and Food and Drug Administration (FDA)-approved in 2012. Its therapeutic significance was further solidified with subsequent extensions in indications to encompass metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer. …
Published in Trends in Drug Delivery · Vol. 11, Issue 2, 2024 · pp. 7–15 Read article
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An in-silico toxicity study of the phytocompounds found in Pongamia pinnata leaves using the ProTox-II web server
Abstract: The aim of the current study was to determine the Insilco toxicity of the phytocompound present in the leaves of Pongamia pinnata. The leaves of Pongamia pinnata have long been used in traditional medicine for their therapeutic properties. Nowadays, herbal toxicity is a common problem caused by incorrect dosage. The FDA reviews the safety and effectiveness of herbal products only in response to patient or health care provider complaints—problems with …
Published in Research and Reviews : Journal of Crop science and Technology · Vol. 13, Issue 1, 2024 Read article
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Comprehensive Approaches to Understanding and Managing Alzheimer’s Disease
Abstract: Alzheimer’s disease is an advanced neurodegenerative disorder described by intense memory loss. It strictly affects the patient’s quality life. The popularity of AD has been increasing in recent years. It is the most common form of mental disorder affecting more than 20 million people in the world. The Alzheimer’s disease is treated with cholinesterase inhibitors or NMDA-receptor (N-methyl D-aspartate) antagonists but here the question is about the therapeutic effect of …
Published in International Journal of Tropical Medicines · Vol. 2, Issue 1, 2025 · pp. 1–9 Read article
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Regulations and Standards in the Dairy Industry
Abstract: The dairy industry is a vital component of the global food system, providing essential nutrients to millions of people worldwide. This article offers a comprehensive overview of the regulatory landscape governing dairy products, focusing on quality standards, labeling requirements, and international trade regulations. Quality standards, established by key organizations such as Codex Alimentarius and the International Dairy Federation, ensure that dairy products meet specific criteria for fat and protein content, …
Published in Research and Reviews : Journal of Dairy Science and Technology · Vol. 13, Issue 2, 2024 · pp. 13–17 Read article
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Melanoma Skin Cancer Detection Using Deep Learning
Abstract: Cancer as one of the major diseases rank in the World is still very challenging to diagnose and treat hence need for the technological advancements. Chemotherapy, radiation, as well as surgery therapies have several drawbacks including non-selective action, damage to healthy tissues, and multi-drug resistance. Smart nano-theranostics, an advanced integration of nanotechnology with diagnostic and therapeutic modalities, offers a next-generation approach for precision oncology. Thus, the development of multifunctional nanoparticles …
Published in Research and Reviews: Journal of Oncology and Hematology · Vol. 14, Issue 2, 2025 Read article