Diabetes is a globally leading metabolic disorder and diabetic nephropathy (DN) is most serious long term complication associated with it. It accounts for approximately 30% to 40% Chronic Kidney Disease (CKD) and up to 45% of end-stage renal diseases. Diabetes mellitus (DM) starts from autoimmune destruction of the β-cells of the pancreas with consequent insulin deficiency/ abnormalities that result in resistance to insulin action; it leads to hyperglycemia. In a diabetic population an increase in highly reactive free radicals inside blood cells and body that alters blood cell membrane properties which causes blood cell aggregation and increased blood viscosity leads to in impaired blood flow. Glycated hemoglobin (hemoglobin A1c, HbA1c, A1C) is a form of hemoglobin that is covalently bound to glucose. Therefore, increases in glycated hemoglobin used as prognostic marker for DM. Due to hyperglycemia the upper and lower urinary tract enriches the soil for various microorganisms. In DN observed the increase in protein excretion in urine which leads to thickening of glomerular and tubular basal membranes, with progressive mesangial expansion (diffuse or nodular) leading to progressive reduction of glomerular filtration surface. Specifically, glomerulus shown the more alterations. Microscopically; mainly found thickening of glomerular basement membrane/ degeneration, mononuclear cell infiltration, glomerular sclerosis is caused by intraglomerular hypertension and septicemic cases suppurtive nephritis. This review will shed light on the pathophysiology and role of glycated hemoglobin in DN due to proteinuria and histopathological changes. Subsequent pathological alterations and accumulation in the renal tissue shown by special staining PAS and Massons trichrome staining.
It has always been known that facilities and processes involved in pharmaceuticals production impact significant on the quality of the product. It is directly related to preserving and improving the quality of life of human beings. So the process controls are mandatory in good manufacturing practices for finished pharmaceuticals and hence, validate it. A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. It helps in significant gaining of deepen understanding of processes, Decreases the risk of preventing problems and thus assures the smooth running of the process, Decreases the risk of defect costs, Decreases the risk of regulatory non-compliance, reduction in failure, improves productivity and decreases the reliance on end product testing to determine whether the product conforms to the desired standard or not. And also to achieved adequate synergic effect of manufacturing process quality. The purpose of this study is to present an Documented introduction and general overview on process validation of pharmaceutical manufacturing process with special reference to cGMP guidelines given under 21 Code of Federal Regulations(CFR) part 211(Current good manufacturing practices for finished pharmaceuticals).
Every pharmaceutical product requires this procedure of quality and validation .In specific if we talk about research products we bring in the GMP practices while manufacturing the product. Most investigational products need to comply with ISO 9001 i.e. the International Standard that specifies requirements for Quality Management System. Thus ensuring good Quality management for a product/ device is the aim. Validating the product so as to confirm the product/device has met the requirements for a specific intend use or application gives the company its baseline standard and the heights to gain people’s trust.
The demand for highly sensitive and selective optical sensors without the need for complex instrumentation and processing has driven the development of novel nanomaterials for optical sensing applications. Nanoparticles have the potential to be used for biosensing in a diversity of fields and could be further developed into multifunctional sensors able to offer sensitive, specific, rapid, and cost-effective solutions for modern biological research and clinical practice.
Micro-sized calcium carbonate was selected to develop polypropylene-based microporous membranes through the MEAUS process (melt extru-sion – annealing – uniaxial strain). Different filler percentages were added to polypropylene (1, 5, 10 wt. % calcium carbonate) Parameters such as draw ratio during extrusion, annealing temperature, strain rate, and strain extension were kept constant to analyze the effect of the calcium carbonate, and content of the obtained membranes. The stress applied involved a pre-orientation of the amorphous tie chains before the crystal chain unfolding, which can be related to the first yield point. A logical pattern of increasing elastic modulus as filler content does is found in calcium carbonate compounds.
WhatsApp us