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48 articles for “US-FDA”
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Review on Impurity Profiling Techniques and their Importance in Pharmaceutical Field
Abstract: Impurity profiling is the process of detection, evaluation and determination of impurities present in any drug (bulk or formulated) or biological product. Impurity profiling comprises elucidation, structure, identification and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations done by LC-MS, GC-MS and CE-MS. The present review discusses many facts related to the analytical methods of development for impurity profiling of drugs. Impurity profiling is …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 8, Issue 1, 2023 · pp. 23–32 Read article
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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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Nitrosamine: The Carcinogenic Impurity in Angiotensin Receptor Blockers
Abstract: Angiotensin II Receptor Blockers (ARBs), commonly known as the Sartans, are used in the treatment of hypertension for a long time. Currently, seven Sartan drugs, i.e. Valsartan, Losartan, Candesartan, Irbesartan, Telmisartan, Olmesartan, and Eprosartan, are in use. Recently, Nitroso impurity was detected in Valsartan active pharmaceutical ingredient, which led to the recall of batches of products containing it. Even in trace amounts, the impurity is said to be a probable …
Published in Research and Reviews: Journal of Oncology and Hematology · Vol. 9, Issue 3, 2020 · pp. 36–43 Read article
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Microbial Safety of Dairy Products
Abstract: Microbial safety is paramount in the dairy industry to ensure the production of high-quality and safe dairy products for consumers. This review article explores the microbial pathogens associated with dairy products, including bacterial and fungal species such as Listeria monocytogenes, Salmonella spp., Escherichia coli, Staphylococcus aureus, mycotoxigenic molds, and yeast species. We delve into the primary routes of contamination, emphasizing sources such as raw milk, processing equipment, and cross-contamination during …
Published in Research and Reviews : Journal of Dairy Science and Technology · Vol. 12, Issue 3, 2023 · pp. 7–11 Read article
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Gene Therapy 2.0: Harnessing Cutting-Edge Technologies for Precision Medicine
Abstract: Somatic gene therapy has become the standard form of gene therapy; this creates the Gene Therapy 2.0 era. This new and distinct time consists in the new-generation genome-editing tools and markers, more efficient systems for gene delivery, and personalized medicine approaches that raise the efficacy and safety of the treatment. Base and prime editing are two types of CRISPR-based gene editing tools have provided high precision and reduced off-target effects …
Published in International Journal of Genetic Modifications and Recombinations · Vol. 3, Issue 2, 2025 Read article
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Tamoxifen: Role in Breast Cancer Treatment
Abstract: Breast cancer is one of the most common cancers among women worldwide. In the last two decades, there have been various therapies proposed for the treatment and prevention of breast cancer. One of them is targeted hormonal therapy (THT) for the estrogen and its receptor in breast cancer. The synthetic selective estrogen receptor modulator, tamoxifen is in the use for treating, estrogen receptor-positive breast cancer from the last 30 years. …
Published in Research and Reviews: Journal of Oncology and Hematology · Vol. 5, Issue 1, 2016 · pp. 1–19 Read article
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Design and Analysis of FIR Filter using Neural Network
Abstract: This paper is intended to provide an alternative approach for comparison of FIR digital filter by using neural network. This proposed approach establishes relation between (I) order and main width lobe of filter and (II) order and cutoff frequency of filter. In this paper is used FDA tool to design digital FIR filters of different orders and neural network tool box to compare different filters. As the simulation results show, …
Published in Current Trends in Signal Processing · Vol. 3, Issue 2, 2013 · pp. 9–14 Read article
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Regulatory Requisites for Registration Process of Medical Devices in United States
Abstract: A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 1, 2017 · pp. 31–41 Read article
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Three-stage Decimation Filter Design with CIC and FIR Filters: A Review
Abstract: In this paper the design of decimation filter with three stages are considered and presented using the FDA tool of MATLAB. The decimation filter reduces the sampling rate of the signal while preserving the required data. The single stage filter is very difficult to implement because it requires more coefficients which results in bad frequency response so three stages of filters are considered, and further decimation is done. In filter …
Published in Journal of Nuclear Engineering & Technology · Vol. 13, Issue 1, 2023 · pp. 30–36 Read article
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Drug Master File—Electronic Submission through eCTD: An Overview
Abstract: A Drug Master File (DMF) is a supporting document for various applications such as Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA), etc. Mainly product’s chemistry, manufacturing, and control (CMC) part is covered in the DMF. As per the current guidelines of US Food & Drug Administration (USFDA), all types of DMFs are mandatory to be submitted through Electronic Common …
Published in Trends in Drug Delivery · Vol. 6, Issue 1, 2019 · pp. 8–13 Read article
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Extemporaneous Compounding: Cautions Vs Convenience
Abstract: Pharmacists are only knowledgeable and skilled healthcare professionals dedicated to compounding and preparing medications to meet the unique needs of patients. The safe and successful extemporaneous compounding of prescription products for patients’ requirement in special consideration is vital to the drug store profession. In any case, there are a lot to improvement in the situation secundum artem. It is not in the least conservative for a pharmaceutical organization to marketize …
Published in Research and Reviews: A Journal of Toxicology · Vol. 9, Issue 1, 2019 · pp. 26–43 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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Diabetes Mellitus-Risk Assessment
Abstract: Objective: To determine the risk of acquiring diabetes in patients and families, as well as the relationship between risk of developing diabetes and certain demographic characteristics. Methods: With 500 samples, a non-experimental descriptive design was utilized to assess the risk of developing diabetes. Convenience or Accidental sampling method was opted, and the data were collected by Bio physiological method and interview method by using ADA and FDA scale. Result: According …
Published in Journal of Nursing Science & Practice · Vol. 12, Issue 2, 2022 · pp. 19–25 Read article
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Identification of Specificity Determining Positions through Phylogenetic Studies and Molecular Modeling of ICP27 as a Drug Target of Herpes Simplex Virus-1
Abstract: An ever-growing effort to apply computational power to the combined chemical and biological space in order to streamline drug discovery, design, development and optimization can be achieved through computational approaches. Herpes simplex is an infection that is caused by a herpes simplex virus (HSV), and is one of the most common human infections transmissible to a body site. Infection with HSV can result in several diseases ranging from apparent infections …
Published in Research & Reviews: A Journal of Bioinformatics · Vol. 2, Issue 1, 2015 · pp. 32–43 Read article
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Digital Therapeutics for Management of Chronic Diseases
Abstract: Digital therapeutics (DTx) mark a major advancement in modern medicine, using advanced software technologies to deliver clinically validated treatments for various physical and mental health conditions. Unlike general wellness apps that focus on fitness or lifestyle tracking, DTx are evidence-based medical interventions developed through rigorous clinical research to ensure safety, efficacy, and measurable outcomes. Delivered via digital platforms such as smartphones, tablets, or specialized medical devices, DTx aim to prevent, …
Published in Research and Reviews : A Journal of Medical Science and Technology · Vol. 15, Issue 2, 2026 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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Risperidone: A Silver Lining In Mental Disorders
Abstract: Risperidone (RYKINDO®) is second generation benzisothiazole which elevates linkage to serotonin type 2 (5HT2A) and dopamine type 2(D2) receptor developed by Luye Pharma Group used in short term palliative treatment of aggression or psychopathic disorders. Both 5HT2 antagonism with D2 receptor, it selectively bind to 5HT2A antagonist and shows neuroleptic effect by Risperidone. It is also available in the form of oral solution and disintegrating tablet etc. It is long …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 10, Issue 3, 2023 · pp. 11–21 Read article
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Tirzepatide : Treatment For Diabetes Mellitus II & Obesity
Abstract: Tirzepatide is a novel medication that the FDA has approved to treat type 2 diabetes mellitus. Tirzepatide is used off-label to treat obesity because` of its powerful weight-loss effects. It Known as the "twin epidemics," the prevalence of obesity and diabetes is a growing issue worldwide, particularly in wealthy nations. Therefore, cutting-edge therapeutic strategies are required. Tirzepatide, Known as a "twincretin," tirzepatide is the only dual glucagon-like peptide-1 (GLP-1) and …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 10, Issue 2, 2023 · pp. 23–32 Read article
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Artificial Pancreas Device
Abstract: This paper gives a brief introduction of the artificial pancreas system. The Artificial Pancreas Device System is a system of devices that closely simulates the glucose regulating function of a healthy pancreas. It mainly focuses on how the device with a special algorithm will help the diabetic patient to live an easy life in a sustainable way. The Food and Drug Administration (FDA) has started to campaign for introducing such …
Published in Research and Reviews : A Journal of Medical Science and Technology · Vol. 8, Issue 2, 2019 · pp. 1–4 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