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551 articles for “regulatory”
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Applications of computational techniques in Gene advancements
Abstract: Deep Learning as well as Advanced Analytics could perhaps assist in controlling the massive, unexpected volume of information obtained from screening programs, legitimate pandemic outbreak scanning, pattern prediction, routine condition checklist as well as upgrading from regulatory establishments or species, or rather medical equipment utilization facts, subsequent breakthroughs of genomic as well as bioinformatics methodologies or data exchange systems. The purpose of this article is to provide a insight of …
Published in Research & Reviews: A Journal of Bioinformatics · Vol. 9, Issue 1, 2022 · pp. 1–8 Read article
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A Review on Junk DNA
Abstract: For many years, although being incredibly catchy, the term junk DNA discouraged mainstream scientists from exploring noncoding genetic material. Among humans, the DNA that actually codes for protein synthesis is 2% only. Hence, the noncoding region of genome is then termed Junk DNA. The junk DNA component is drastically different. Hence at the time of investigating the role of satellite DNA for the fertility and survival in pure species, the …
Published in Research and Reviews : A Journal of Biotechnology · Vol. 13, Issue 2, 2023 · pp. 6–9 Read article
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Impact Of Pesticides On Human Body Due To Soybean Farming In The State Of Madhya Pradesh
Abstract: Worldwide, agricultural areas, including the Sehore district of Madhya Pradesh, India, are growing concerned about pesticide pollution. This research aims to determine the extent and effect of pesticide pollution around the region's soybean Farming. In the Sehore district, soybean is an important agricultural product and a revenue generator for the Government. Pesticides are used extensively to control pests and illnesses which could harm the soybean farm. The study used various …
Published in Journal of Modern Chemistry & Chemical Technology · Vol. 14, Issue 3, 2023 · pp. 49–55 Read article
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Effects of Restrictions during COVID-19 on Air Quality in India: An Opportunity to Reshape the Earth
Abstract: The massive increase in the human population, rapid industrialization, and growth in technology has made our life comfortable and luxurious. However, it has come with the price tag of extreme exploitation of our planet earth. Our species have pushed the planet earth against its carrying capacity, damaging the earth’s own restoration capacity to filter the harmful pollutants. One of the outbreaks of this is air pollution. Chronic exposure to air …
Published in Research & Reviews : Journal of Ecology · Vol. 10, Issue 1, 2021 · pp. 1–13 Read article
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Ayurvedic Pharmacopoeia of India (A.P.I.), Part I, Volume IX: A Review
Abstract: Pharmacopoeia is a regulatory compendium of monographs on quality standards to ensure the quality, safety and efficacy of drugs and medicines of a particular system of medicine in a country. In this communication, Ayurvedic Pharmacopoeia of India, Part I, Volume IX is reviewed for its contents, monographs and utilitarian aspects in regulations of Drugs & Cosmetics Act 1940 for Ayurvedic system of medicines. Keywords: Pharmacopoeia, Ayurvedic Pharmacopoeia of India, Drugs …
Published in Research & Reviews : Journal of Herbal Science · Vol. 7, Issue 2, 2018 · pp. 4–9 Read article
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Panchkarma in Janpadodhwansa w.s.r. COVID-19 and Its Documentation from Ayurvedic Texts
Abstract: COVID-19 has emerged as a public health crisis and has done caused a disaster at multiple -levels. Manual retrieval of ancient books of Ayurveda was carried out. In From an Ayurvedic point of view, its very difficult to correlate COVID-19 with Aayurvedic terminology, on the basis of causes, symptoms, and complications., Iit can be correlated with various diseases like Janpadodhwansha(~epidemic), Shwasa(respiratory disease), pranaavrit vata(subtype of vata that is seated in …
Published in Research & Reviews : Journal of Herbal Science · Vol. 12, Issue 2, 2023 · pp. 28–37 Read article
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Seasonal Assessment of Radon, Thoron and their Progeny levels in the Dwellings near the Fly Ash Dumping Site situated in Faridabad (Haryana), India
Abstract: In order to meet the growing demand forof electricity, coal- based thermal power plants are widely used all over the world. These thermal power plants produce a huge amount of fly ash as a by- product of coal combustion. The disposal and management of this ash become a challenging problem for the environmentalist and scientist. Coal ash contains an enhanced level of radionuclides along with some other elements, that are …
Published in Research & Reviews : Journal of Physics · Vol. 8, Issue 2, 2019 · pp. 27–36 Read article
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Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development
Abstract: Bioavailability (BA) has an important role in new drug discovery and product development in pharmaceutical field. The solubility and permeability are important parameters of biopharmaceutics and have central role in lead optimization by controlling the pharmacokinetic parameters to give better therapeutic activity. Biopharmaceutical classification system (BCS) is a drug development tool that is based on correlation of solubility and permeability with bioavailability of drug in human body. The principles of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 1–16 Read article
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Homoeopathic Pharmacopoeia of India (H.P.I.), Tenth Volume: A Review
Abstract: Pharmacopoeia is a regulatory compendium of monographs on quality standards to ensure the quality, safety and efficacy of drugs and medicines of a particular system of medicine in a country. In this communication Homoeopathic Pharmacopoeia of India, ‘Volume Ten’ is reviewed for its contents, monographs and utilitarian aspects in homoeopathic system of medicine. Keywords: Pharmacopoeia, homeopathic pharmacopoeia of India, Drugs and Cosmetics Act 1940 and Rules thereunder Cite this ArticleNitin …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 3, 2017 · pp. 6–11 Read article
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Pharmaceutical Product Registration Requirements in ASEAN & CIS Countries
Abstract: The Association of Southeast Asian Nations (ASEAN) and the Commonwealth of Independent States (CIS) nations are two of the emerging pharmaceutical markets. There is a rise in income levels of middle class, rise in health consciousness and growing burden of disease among the aged groups which has led to an increased demand for general and lifesaving medicines in the emerging pharmaceutical markets. This paper approaches the pharmaceutical product registration requirements …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 2, 2014 · pp. 6–10 Read article
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Review on Different Approaches of Drug Development Process
Abstract: This paper is all about the process of bringing a new compound into the market. Different approaches to drug development are mentioned. Function of drug development to assess all parameters prior to human clinical trials and satisfying the regulatory requirements of drug licensing authorities, generally a number of tests are designed to determine the major toxicities of a novel compound prior to first use in man are the objectives of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 2, 2014 · pp. 18–21 Read article
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Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European Union
Abstract: Developing a new drug requires a great amount of research works in chemistry, manufacturing, controls, preclinical science and clinical trials. European Union (EU) is a hub of political and economic union of 28 member states (MS) and extensive amount of effort was spent by the EU Commission, the EU parliament, the European Medicines Agency (EMEA) and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 8–15 Read article
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Pharmaceutical Drug Product Registration and Requirements in Latin American Countries
Abstract: The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 22–29 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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A Brief Note on Different Concept of Biowaiver
Abstract: The aim of the present work was to understand the concept of to waive a complete and systemic bioequivalence (BE) study. Biowaiver or request for a biowaiver is a fast track approach to boost the drug development process. Over the past three-four years, the biowaiver market has shown greater number of biowaiver submissions and the wider use of in-vitro permeability study. Biowaiver is a beneficial approach for getting approval of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 22–30 Read article
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In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development
Abstract: In a recent era many concepts are dealing as an emerging tool for the drug delivery application like Biopharmaceutical Classification System (BCS), In vitro and In vivo study, and Bioavailability/Bioequivalence (BA/BE) study etc. To determine Therapeutic efficiency in vitro is not enough so the concept of In vitro-In vivo correlation (IVIVC) is playing as an convincing correlation with this for concept of pharmaceutical dosage forms have been a main focus …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 3, 2016 · pp. 31–54 Read article
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Design And Evaluation Of Meloxicam Tablet For Colon Cancer
Abstract: Meloxicam, recognized as a preferential COX-2 inhibitor, has emerged as a promising chemopreventive agent for colorectal cancer. Leveraging its local and targeted action on the colon, Meloxicam proves to be a formidable component in the prevention of colorectal malignancies. This study aims to innovate by formulating and evaluating a targeted tablet delivery system for Meloxicam, emphasizing site-specific and instant drug release in the colon, thereby maximizing its therapeutic efficacy in …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 10, Issue 3, 2023 · pp. 1–7 Read article
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Pharmaceutical Product Registration and Requirements in CIS Countries
Abstract: Commonwealth of Independent States (CIS) has been identified as one of the emerging markets due to the phenomenal growth of the pharmaceutical industry. It has estimated that pharmaceutical sector in Russia and other CIS nations with CAGR of 10–11% during the year 2012–2016. Russia holds 14% of CIS market in 2013 whereas pharmaceutical market in Ukraine and Kazakhstan contributed to 3–4%, respectively. The Federal Service for Surveillance in Healthcare and …
Published in Trends in Drug Delivery · Vol. 1, Issue 3, 2014 · pp. 1–8 Read article
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Pharmaceutical Products Registration Requirements for ASEAN and GCC Countries
Abstract: Registration of pharmaceutical products is a challenge and an important task in regulated, semi regulated as well as rest of the world countries. Although the requirements are harmonized in regulated countries by Common Technical Document (CTD) filing, yet others have enormous diversity in requirements. The purpose of the present study is to understand the requirements for registration of drug products in countries like the Association of South East Asian Nation …
Published in Trends in Drug Delivery · Vol. 1, Issue 3, 2014 · pp. 9–16 Read article
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Pharmaceutical Drug Regulations and Registration Process to Russia
Abstract: Commonwealth of Independent States (CIS) has been identified to be one of emerging markets due to the phenomenal growth of the pharmaceutical industry. It has been estimated that pharmaceutical sector in Russia and other CIS nations with CAGR of 10 to 11% during the year 2012–2016. Russia holds 14% of CIS market in 2013. The choice of Russia as one of the destination for the market of the drug products …
Published in Trends in Drug Delivery · Vol. 2, Issue 2, 2015 · pp. 8–18 Read article