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 |
A simple, accurate, precise and sensitive first-order UV – Spectrophotometric assay method has been developed and validated for the quantitative estimation of fluvastatin sodium in pharmaceutical dosage forms. The solvent to dissolve the drug and for dilutions, methanol was used. The absorption maxima of fluvastatin sodium in methanol after derivatized into the first-order derivative was found to be 306nm. The drug obeyed Beer’s law in the concentration range of 1 – 5µg/mL with correlation coefficient of 0.9997. The developed method was validated as per the ICH guidelines. The % recovery values were found to be within limits, which showed that the method was accurate. The % relative standard deviation values were less than 2, indicating the method was found to be precise. Limit of detection and limit of quantitation were calculated using statistical methods. The developed method can be used for the quality control of fluvastatin sodium in pharmaceutical dosage...
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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 |
To predict the cocos anther dehiscence, a novel method was devised to compile the colossal amount of pollen grains. The matured inflorescence enveloped by the spathe was collected and the anther dehiscence were noticed day by day until the shedding of entire pollen. This study was experimented for a period of eight months between (February) 2018 to 2018 (September). After an experimental trails, sieve and a new tool wrist action shaker methods were used to collect the healthy pollen grains. Proximate analysis was determined by food analysis-FSSAI and association of analytical chemicals method. The complete process of anther dehiscence took 12 -18 days and after an experimental trials the high amount of pollen grains were obtained on the twelfth day. During the month of June amount of pollen i.e. 16.21 ± 0.05 g per 100 g of the fresh flower weight was recorded in wrist action shaker whereas 2.36 ± 0.018 g per 100 g of the flower weight found in sieve method. The average dry weight of pollen...
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Posted by admin on Nov 30, 2021 in |
Heavy metal accumulates mostly in the liver and kidney as these organs involved in the detoxification and excretion of foreign materials. In the present study, we explored the effect of Gum Arabic (GA) and Guar Gum (GG) on mercuric chloride (HgCl2) induced hepatorenal toxicity. Twenty-eight adult male albino rats “Sprague Dawely” weighing 250-300 g were divided into four equal groups: the first group served as the negative control group, the second group received intraperitoneal (I.P.) injection with HgCl2, the third group received HgCl2 injection followed by GA and the fourth group received HgCl2 injection followed by GG. HgCl2 injection caused a significant increase in serum total bilirubin, aspartate aminotransferase (ALT), alanine aminotransferase (AST), creatinine, urea, and uric acids compared to control. Moreover, there was a significant reduction in tissue-reduced glutathione (GSH) with a marked increase in the tissue hydroxyproline content and TGF-β% in the liver and kidney. Also, hepatorenal intoxication was confirmed by histopathological examination compared with the control group. Treatment with GA or GG showed significant recovery (p...
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