Posted by admin on Nov 30, 2021 in |
A similar biologic product also called biosimilar, follow-on biologic, is highly similar in terms of quality, safety, efficacy with that of the reference product. These are the pharmaceutical products used as the prime treatment options in many chronic diseases and as substitutes for the primary treatment. For development and approval, each nation has adopted its own regulations, and some countries are adopting WHO guidelines. In India Institutional BioSafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC), CDSCO are the competent authorities involved in the approval process. In EU the legal basis of Article 10(4) of Directive 2001/83/EC lays down the requirements for the Marketing Authorization Applications (MAAs) based on the demonstration of the similar nature of the two biological medicinal products. The US Biologics Price Competition and Innovation Act of 2009 (BPCIA) permits the licensing of biological products. During the development process, the biosimilar developer should consider specific parameters like the manufacturing process, demonstrating analytical similarity, which includes structural and functional similarity, interchangeability, and...
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Posted by admin on Nov 30, 2021 in |
Oral ulcers have been a source of diagnostic difficulty. This has been due to the overlap in their clinical appearances. The problem is complicated because a number of oral ulcers may be superimposed by infections due to their easy access to the oral cavity and the thin nature of the oral mucous membrane is an additional challenge to their diagnosis. While the diagnosis of some types of oral ulcers is done by their association with constitutional signs and symptoms or lesions on the skin and/or mucous membranes in other regions, ulcers that are localized only to the oral cavity may be more difficult to identify. Most oral ulcers are, biopsied because they are less readily recognizable on the basis of their clinical features. The similarity in histologic features due to contamination by the oral liquids and microflora also, on occasion, makes it difficult to distinguish by masking the basic pathology. Proper history taking, including the personal history and a thorough clinical examination, is a must to rule out malignancy....
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Posted by admin on Nov 30, 2021 in |
In recent years, it has been reported that many herbal plants contain antiviral agents which combat a human disease that is caused by pathogenic viruses. The natural products which are obtained from plants as antiviral agents against viruses have gone through researches to check the efficacy and potentials of the herbal products in the prevention of viral disorders. On the basis of randomized controlled studies and in-vivo studies, and in-vitro studies, some agents are utilized all across the globe. Progressively numerous studies on therapy of antivirals have been increased. Though, efficacy remains disputable for antiviral drugs that are employed for viral disorders. The viral diseases are challenging for the health of people around the world cause significant increase in mortality and enhance crises. There are many synthetic antiviral drugs that have a large number of side effects and have narrow therapeutic window range, while in the other hand herbal formulations have minimized side effects. The advantages of herbal formulation over synthetic drugs encourage us to devise and expand new...
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Posted by admin on Nov 30, 2021 in |
The earliest anecdotes of ‘medical device’ dates back thousands of years. In 7000 BC, Neolithics used flint-tipped drills and bowstrings for dentistry. However, regulation of medical devices has only happened recently. Modern medical devices are used for the diagnosis, cure, mitigation, treatment, or prevention of disease. This industry is one of the most dynamic, disruptive, and fastest-growing among all segments in healthcare. However, there are challenges. The transition from innovation to patient care and eventually financial success has proven to be the Achilles hill for most organizations attempting to create a niche within the industry. There has been a multitude of problems to deal with. Financial, operational, technological, and regulatory issues have been plaguing the industry for years. Thankfully, with the advent of new-age technologies like artificial intelligence and machine learning, we are witnessing a paradigm shift in this space. In this review article, we delve deep into the history, evolution, and challenges in the medical devices space. We also look at the emerging technologies that are shaping the...
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Posted by admin on Nov 30, 2021 in |
Mucormycosis is an opportunistic fungal infection caused by a member of the order Mucorales. It is an angio-invasive fungal infection because of its propensity to invade blood vessel walls, resulting in catastrophic tissue ischemia (restriction in blood supply to tissues, causing a shortage of oxygen that is needed for cellular metabolism), infarct (tissue death that is necrosis) due to inadequate blood supply to the affected area. Mucorales fungi are distributed worldwide and found in soil and decaying organic substrates. The most common microbiologically confirmed infecting members of the order Mucorales are Rhizopus, Mucor, Cunninghamella bertholletiae, Apophysomyces elegans, Absidia, Saksenaea and Rhizomucor pusillus. The incidence of mucormycosis has increased significantly in patients with diabetes which is the commonest underlying risk factor globally. Recently, COVID-19 caused by SARS CoV-2 has further worsened the incidence of this disease. Diagnosis of mucormycosis remains challenging. The clinical approach to diagnosis has a low sensitivity and specificity; however, it helps raise suspicion and prompt the initiation of laboratory testing. Histopathology, direct examination, and culture remain essential tools,...
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