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69 articles for “GENERICS”
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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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Regulatory Requirements for Registration of Generic Drug Product in Brazil
Abstract: Drug Product Registration is a procedure of expertise of the pharmaceutical products quality, efficacy and safety by Regulatory Authority. This present study focuses mainly on the marketing regulatory requirements for filing a generic product, the regulations that are applicable for the Pharmaceutical drug products. The emergence of various formats has enabled the manufacturers of the drug product, to easily gain access into various markets and thus, able to place their …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 2, 2015 · 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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Blockchain Technology for Strengthening the Indian Generic Medicine Supply Chain and Combating Counterfeit Drugs
Abstract: India is one of the leading distributors of generic medicines globally, but its supply chain faces numerous challenges including substandard medicines, counterfeiting, and inefficient logistics. Blockchain technology offers a promising solution by providing a secure, decentralized, and transparent platform to track and verify the entire drug supply chain from production to delivery. This paper investigates the potential of blockchain to mitigate counterfeit drug circulation, improve trust in Indian generic medicines, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 3, 2024 · pp. 9–12 Read article
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Compulsory Licensing – The Effect on Generics, Patents and Drug-Development in Indian Pharma
Abstract: The objective of the present study was to analyse the effect of compulsory licensing (CL) on Generics, Patents and Drug-Development in India. This analytical study was carried out by collection of the data with respect to research questions. The data were collected from WTO, research articles, journals, ICMR and DCGI guidelines, Drugs and Cosmetics Act, WHO guidelines, TRIPS agreement, Indian Patents Act. The results revealed that expiry of three years …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 5, Issue 1, 2014 · pp. 1–13 Read article
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An Overview of GMP Requirements for Generics in Brazil and Russia
Abstract: Implementation of good manufacturing practice (GMP) is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the key GMP requirements for manufacturing of generics in Brazil and …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 7–14 Read article
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Design and Development of a Triboelectric Sensor for a Generic Counting Application
Abstract: In today’s consumer-oriented market, researchers are increasingly focusing on harvesting energy from ambient and renewable sources to enable sustainable power generation and reduce dependency on conventional energy resources such as batteries and fossil-fuel-based electricity. The rapid growth of portable electronics, wireless sensor networks, and Internet of Things (IoT) devices has created a significant demand for low-power, long-life, and maintenance-free energy solutions. In many practical situations, frequent battery replacement is difficult, …
Published in Journal of Experimental & Applied Mechanics · Vol. 17, Issue 1, 2026 · pp. 38–48 Read article
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Post Approval Life Cycle Management of Variations for Generic Drugs in Brazil
Abstract: Changes or variations in respect of any information concerning the registered or approved drug products, including information on the formulation of the registered/listed goods or other aspects of their manufacture, and the labeling of the goods, shall forthwith be notified to the agency and the change or variation shall not be implemented until approved by the agency. Changes occurs to have business continuity, if any quality problem arises, to maintain …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 3, 2017 · pp. 37–42 Read article
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Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics
Abstract: Getting a marketing approval includes various junctures such as getting drug substances from approved vendors, finished product development, clinical studies, plant inspection, dossier writing and finally submission to authorities. US, Europe, Japan and Canada are the countries which are regulated for the approval of pharmaceutical products. These countries follow the ICH guidelines for the registration of drug of drug product. But each country has different type of application for the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 1–7 Read article
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Generic Virtual Mouse
Abstract: The mouse and keyboard have been replaced by new input mechanisms brought about by the quick development of Human-Computer Interaction (HCI). Using computer vision and deep learning techniques, this study explores the possibility of replacing actual mouse inputs in a computer system with hand gestures. We created a virtual mouse system that uses a normal webcam to record hand motions. Computer vision algorithms then process these gestures to handle mouse …
Published in Current Trends in Signal Processing · Vol. 15, Issue 2, 2025 · pp. 26–32 Read article
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Application of Generic Multi-criteria Economic Model for Line Balancing to a Hypothetical Organization Using Soft Computing Techniques
Abstract: Total Productive Manufacturing (TPM) is feasible only if the Overall Equipment Effectiveness (OEE) of the production line meets world-class standards. In the current research, crisp and fuzzy simulation models are developed and implemented for exploring OEE parameters for a hypothetical manufacturing organization. As OEE parameters, availability, performance efficiency, and quality, in turn, depend on several other parameters, a sort of cascaded effect is generated which can effectively be modeled as …
Published in Journal of Artificial Intelligence Research & Advances · Vol. 10, Issue 1, 2023 · pp. 105–122 Read article
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Cloud Enabled Machine Learning Framework for Medicine System
Abstract: The Medicine Generic App is a cutting-edge mobile application designed to empower users with information about generic medications. Given the rising expenses of healthcare and prescription medications, this app acts as a useful resource for consumers to make informed decisions regarding their medication options. The Medicine Generic App aims to promote generic drug usage, reduce healthcare costs, and improve medication management for users. By providing detailed information and price transparency, …
Published in International Journal of Mobile Computing Technology · Vol. 3, Issue 1, 2025 · pp. 1–6 Read article
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A Study and Report on Due (Drug Utilization Evaluation) of Cardiovascular and Endocrine Disorders/Diseases in Inpatient Units of Hospitals
Abstract: In recent years drug utilization studies have become a potential tool to be used in the evaluation of health systems. On the process of drug utilization studies focus on factors related to prescribing, dispensing, administering, and taking of medication, and its associated events. Drug utilization data are available from databases- computerized or otherwise. From these databases different types of information, qualitative or quantitative or referring to a particular population are …
Published in Trends in Drug Delivery · Vol. 8, Issue 3, 2023 · pp. 11–32 Read article
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Elaborate Business Dimension of Business Oriented Business Rule Framework
Abstract: AbstractWe explore business rules from the business perspective with the aim of developing information/software systems. We underpin our work with a 4-dimensional framework of business rules consisting of the business, system, representation, and application dimensions. We focus on the business dimension here and elaborate it at three levels. These levels consist of the generic model, the business-independent governance model, BIGm, and the business-specific governance model. At the generic level, we …
Published in Journal of Image Processing & Pattern Recognition Progress · Vol. 6, Issue 1, 2019 · pp. 24–35 Read article
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Prescribing Pattern of Nonsteroidal Anti-inflammatory Drugs among the Specialists Doctors in Mymensingh City of Bangladesh—A Descriptive Study
Abstract: Irrational prescribing of medicines is a global problem, particularly in developing and transitional countries like Bangladesh, and so drug use patterns need to be evaluated. The aim of the study was to investigate the prescribing patterns of nonsteroidal anti-inflammatory drugs (NSAIDs) among the specialist doctors in Mymensingh city of Bangladesh. Prescriptions were collected from patients visiting different hospitals and pharmacies in different areas of Mymensingh city. A total number of …
Published in Research and Reviews: A Journal of Pharmacology · Vol. 8, Issue 2, 2018 · pp. 19–23 Read article
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Supergenerics Regulation in India and US: A Comparative Review
Abstract: ‘Supergenerics’, a new form of generic drugs with improved properties such as safety, efficacy, stability or improved commercial attractiveness such as taste or route of administration. Those drugs are most often based on an incremental re-formulation of a generic API (active pharmaceutical ingredient) or the combination of multiple generic APIs. Process of forming supergeneric molecule need not to be complex all the time. A supergeneric may be as simple as …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 1, 2016 · pp. 30–38 Read article
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Reducing the Uncertainty of Marine Accidents Failure Rate in Harsh Environment; Using Bayesian Theory
Abstract: The interest in arctic activities is strong, but has not led to significant quantifying analysis over the fact of finding rescannable failure rate. To attract investors and promote the development of a marine industry, a clear concept of project risk is paramount; in particular, issues relating to human role in operation are critical. In the public domain, reliability of information is often scarce or inappropriate for such environment. Also, an …
Published in Journal of Industrial Safety Engineering · Vol. 3, Issue 2, 2016 · pp. 30–39 Read article
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A Study to assess Prescription pattern in outpatient department of tertiary care hospital
Abstract: ABSTRACTBackground:Antibiotic resistance and irrational prescribing is a global concern, is particularly pressing in developing nations, including India, where the burden of infectious disease is high and healthcare spending is low. The Global Antibiotic Resistance Partnership (GARP) was established to develop actionable policy recommendations specifically relevant to low- and middle-income countries where suboptimal access to antibiotics - not a major concern in high-income countries - is possibly as severe a problem …
Published in Journal of Nursing Science & Practice · Vol. 8, Issue 2, 2018 · pp. 33–36 Read article
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A brief review on Influenza A virus (H 3 N 2 ) and its effects in human with precondition
Abstract: A primary cause of human influenza is the viral genus Influenzavirus A, of which H3N2 is a subtype. The virus has undergone various mutations, resulting in the emergence of different strains, affecting pigs, humans, and birds. H3N2 exchanges internal protein-coding genes with other influenza subtypes through reassortment. The H3N2 virus, which is a type of seasonal influenza A virus, is still circulating globally and is causing symptoms very similar to …
Published in Research and Reviews: A Journal of Microbiology and Virology · Vol. 13, Issue 1, 2023 · pp. 13–17 Read article
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Drug Utilization Study of Anti Rheumatoid Drugs in Patients with Rheumatoid Arthritis at a Tertiary Care Hospital
Abstract: Background: Rheumatoid arthritis (RA) is a chronic disease that is classified as an autoimmune illness. It is characterized by joint inflammation, which can subsequently cause joint destruction. This leads to disability and a decline in quality of life. An analysis of drug usage is an important way of assessing prescribing habits and evaluating the rationality of drug use in an effort to achieve optimal therapeutic results among RA patients. Objectives: …
Published in International Journal of Orthopedic Nursing and Practices · Vol. 4, Issue 1, 2026 · pp. 14–20 Read article