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537 articles for “regulatory”
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Servo and Regulatory Response of Non-linear Spherical Tank System
Abstract: The highly nonlinear spherical tank system is employed in many process industries for huge storage. The nonlinearity is due to the cross-sectional area of the tank with respect to its height. Thus, the level control of the spherical tank system is a challenging task. The diverse controller methods are existing for level control, in which 95% of controllers employed are Proportional, Integral, and Derivative (PID) controllers. In this paper, to …
Published in Journal of Instrumentation Technology & Innovations · Vol. 6, Issue 2, 2016 · pp. 6–14 Read article
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Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario
Abstract: The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 32–39 Read article
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Regulatory Requirement for Supergenerics in Saudi Arabia, Brazil and Malaysia
Abstract: Supergeneric is the general form of nomenclature for value-added generics globally, which is coined suitably in different regulatory authorities. The supergeneric form of the medicinal product is one that considers changes, which may not be limited to, form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly of results of preclinical tests and clinical trials of an innovator product and also on new data …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 3, Issue 1, 2016 · pp. 38–45 Read article
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Regulatory Requirements for Registration of Generic Drug Products in Japan
Abstract: Drug registration is a procedure of expertise of the pharmaceutical product quality, efficacy and safety by regulatory authority. The emergence of various formats has enabled the manufacturers of drugs to easily gain access into various markets and thus, was able to place their products in the market. The choice of Japan as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. …
Published in Trends in Drug Delivery · Vol. 2, Issue 2, 2015 · pp. 19–27 Read article
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AI-Driven Psychological Profiling on Social Media: Mechanisms, Ethical Breaches, and Regulatory Challenges in Data Inference
Abstract: This literature review examines AI-driven psychological profiling on social media, analyzing 21 academic studies that focus on machine learning techniques such as supervised learning, deep neural networks, sentiment analysis, and natural language processing. These methodologies infer mental health indicators—such as depression, anxiety, and stress—from users' digital footprints, encompassing linguistic patterns, engagement metrics, and temporal behaviors. While these tools offer potential for early detection of psychological distress, they also raise significant …
Published in Recent Trends in Social Studies · Vol. 2, Issue 1, 2025 · pp. 1–7 Read article
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Environmental Pollution and Health Concerns in India: Regulatory Measures and Public Activism
Abstract: Environmental pollution affects human health significantly and is a major global problem. This chapter goes into great length on the various types of environmental pollution that affect the air, water, and soil, along with their primary causes. By analyzing the many health problems associated with each type of pollution, it draws attention to the complex link that exists between pollutants and human health. Reproductive issues, cancer, neurological problems, cardiovascular diseases, …
Published in Research & Reviews : Journal of Ecology · Vol. 14, Issue 3, 2025 · pp. 12–17 Read article
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Detection of Radioactive Material Out of Regulatory Control: A Radiation Dose Survey of a University Environs in Rivers State, Nigeria
Abstract: This research investigates radiation levels at refuse dump sites and laboratories within the University of Port Harcourt, Nigeria environs and assesses the associated risks to human health and the environment. The study utilizes two radiation detection instruments namely the Personal Radiation Detector and the Radioisotope Identifier Device. The PRD offers real-time detection and spectroscopic analysis of gamma and neutron radiation, while the RID combines gamma and neutron radiation detection with …
Published in Journal of Nuclear Engineering & Technology · Vol. 13, Issue 2, 2023 · pp. 1–11 Read article
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Regulatory Perspectives of Ayurvedic, Siddha and Unani Formularies and Pharmacopoeias
Abstract: The Ayurvedic Formulary of India, Ayurvedic Pharmacopoeia of India, Siddha Formulary of India, Siddha Pharmacopoeia of India, National Formulary of Unani Medicine, Unani Pharmacopoeia of India are included in the Schedule I of the Drugs and Cosmetic Act 1940 and rules made thereunder and serve as a tool for regulatory compliance and standardization tool for the Ayurvedic, Siddha and Unani system of medicines respectively. The Pharmacopoeias of Ayurvedic, Siddha and …
Published in Journal of AYUSH: Ayurveda, Yoga, Unani, Siddha and Homeopathy · Vol. 6, Issue 2, 2017 · pp. 56–64 Read article
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Issues, Strategies, Regulatory Concerns for Monitoring and Management of Water: Microplastics, Microorganisms and Emerging Pollutants
Abstract: Water is regarded as a multi-purpose and eccentric resource as it performs plethora of vital functions essential for human body. Water pollution is responsible for contaminating drinking water sources, food moieties and causing adverse health implications. Access to clean and reliable water is imperative for ensuring healthy lifestyle and prevention of diseases with direct impact on economy and social life. A wide variety of emerging pollutants (viz. microplastics, Phthalates, BPA …
Published in Journal of Water Pollution & Purification Research · Vol. 9, Issue 2, 2022 · pp. 1–13 Read article
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Growth Regulatory Activities of Different Extracts of Few Ornamental Plants on Radish (Raphanus sativus) with Chemical Investigation
Abstract: AbstractAn experiment was conducted to study the effects of aqueous extracts of few ornamental plants viz. China box (Murraya exotica), Indian Medlar (Mimusops elengi), Parrot tree (Butea monosperma) Mussaenda (Mussaenda erythrephytta), Mast tree (Polyalthia longifolia) and Swamp tree (Thuja occidentalis) on the germination and growth of radish (Raphanus sativus) aqueous extract of Mussaenda plant extract showed the highest percentage of germination shoot length, root length and chlorophyll contents of radish …
Published in Research and Reviews : Journal of Crop science and Technology · Vol. 5, Issue 3, 2016 · pp. 16–20 Read article
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Drug Discovery and Development: An Overview from the Regulatory Prospective
Abstract: The improvement of medication from an underlying plan to its entrance into the market is an extreme process which can take around 5–10 years and cost $1.7 billion. The thought for another advancement can originate from an assortment of sources which incorporate the flow necessities of the market, new rising infections, good clinical research, business part, and so on. Once an objective for revelation has been picked, the pharmaceutical businesses …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 6, Issue 1, 2019 · pp. 1–9 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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European Regulatory Perspective on Super-Generics: Antacid Orally Disintegrating Tablets (ODT)
Abstract: Super-generic is the general form of nomenclature for hybrid medicinal product in European Union (EU). The super-generic form of the medicinal product is one that considers changes in the form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly on results of preclinical tests and clinical trials of an innovator product and also on new data with appropriate bioavailability and bioequivalence studies. Marketing authorization …
Published in Trends in Drug Delivery · Vol. 3, Issue 1, 2016 · pp. 31–37 Read article
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Investigations on Anthocyanin and Its Regulatory Role
Abstract: Anthocyanin is the most widely studied and abundant group of natural pigments. It has been gaining increased attention for its potential health benefits. This vibrant, water-soluble pigment is found in fruits, vegetables, and flowers, and is responsible for the colors of many of the foods we eat. Anthocyanins are not only responsible for the aesthetic appeal of these foods, but they are also believed to have powerful antioxidant, anti-inflammatory, and …
Published in Research and Reviews : A Journal of Biotechnology · Vol. 14, Issue 1, 2024 · pp. 32–37 Read article
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THE REGULATORY ROLE OF FOOD SPICES AGAINST LIPID PEROXIDATION IN MEAT PRODUCTS
Abstract: Spices are plant-based materials used for enhancing the flavor, taste and aroma of meat and have been employed in cooking and meat processing for many decade. Interestingly, some of these spices have found relevance in meat preservation as they not only enhance the flavor and taste of meat product but can also reduce meat spoilage. One of the major causes of meat spoilage outside those induced by microbes is Lipid …
Published in Research & Reviews : Journal of Food Science & Technology · Vol. 13, Issue 3, 2024 · pp. 21–25 Read article
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Review article on Quality Control in Clinical Trials
Abstract: Quality control (QC) is a critical component in the conduct of clinical trials, ensuring the accuracy, reliability, and credibility of data collected throughout the study. It encompasses a systematic set of procedures designed to monitor trial conduct and data integrity, thus safeguarding the rights, safety, and well-being of participants. This review explores the principles, implementation, and evolving practices of quality control in clinical trials, highlighting its importance across all phases …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 3, 2025 · pp. 01–07 Read article
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Advancements in Analytical Techniques and Validation Methods for Pharmaceutical Tablet Formulations Using HPTLC
Abstract: High Performance Thin Layer Chromatography (HPTLC) is a versatile analytical technique which has been effectively used for pharmaceutical quality control and cost effectively, rapidly, and high throughput analyzed tablet formulations. HPTLC is different from traditional chromatographic methods as multi sample analysis is possible in one run with low consumption of solvent, which are principles of green analytical chemistry. But existing HPTLC is limited in sensitivity, resolution and reproducibility and these …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 3, 2026 Read article
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Revamping of Pharmaceutical Manufacturing Processes
Abstract: The pharmaceutical sector is entering a new era marked by technological advancements and an emphasis on sustainability and efficiency. A commitment to compliance can help boost consumer confidence and regulatory approval. This abstract explores the multifaceted approach to revamping pharmaceutical manufacturing processes, encompassing technological integration, regulatory compliance, and sustainability initiatives. Technological advancements, including automation, data analytics, and artificial intelligence, are playing a pivotal role in streamlining manufacturing operations. These innovations …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 38–44 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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Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries
Abstract: The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 28–36 Read article