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Search Results: 1 - 10 of 198392 matches for " Sharma D "
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REGULATORY ASPECT OF PHARMACEUTICAL CHANGE CONTROL SYSTE
Sharma D,Sharma V
Journal of Drug Delivery and Therapeutics , 2011,
Abstract: The change control is ―A process that ensures that changes to materials; methods, equipment and software are properly documented, validated, approved and traceable‖. The process requires eight basic steps: Identification, documentation review, change proposal, change classification, implementation plan, installation, verification, closure. Changes are outlines as Major, Moderate & Minor. A compliance of regulatory group within the company determines the filing impact and submits it to FDA,-A prior- Approval supplement (PAS) for major changes, A CBE -30 or CBE-0 for moderate changes or Annual report for Minor changes. Firms are expected to write adequate Standard Operating Procedure (SOP) for the change control & be in total compliance with proper documentation. Considering the regulatory prospective of change control procedures, it is important to note that there are many guideline which describe the control of changes in manufacturing few references includes 21 CFR Part211: Sec. 211.100, 21 CFR Part 211.194 (Laboratory Records), ICH Q7A and USFDA Guidance for Industry: Change to an approved NDA or ANDA (April 2004- Revison-1).
Prevalences of Simian, Sydney and Suwon Creases and their Association with Each Other, Body Sides, Handedness, Sex and Anomalies/Diseases/Syndromes in a Population of Central India
Sharma,D. K; Sharma,Vandana;
International Journal of Morphology , 2011, DOI: 10.4067/S0717-95022011000300069
Abstract: the simian and sydney creases are variant palmar creases which have now drawn medical attention as their presence correlates strongly with numerous chromosomal anomalies and diseases. works on these creases have been done on several human communities, racial and ethnic but no specific study is focussed out on the indian populations. in this study 1000 central indian subjects (500 males and 500 females) aged between 5 to 70 years were randomly selected and examined by the authors. we found the prevalence of simian, sydney and suwon creases in studied population of central india is 14.4%, 3.6% and 2.4% respectively, which is a little higher than the figures for asians and caucasians claimed by earlier studies. there is no any association between these creases. the simian crease is predominantly unilateral right side and associated with handedness. it is more common in males. the sydney crease does not have unilateral or bilateral predominance and association with handedness but it is more common in females. the suwon crease does not have unilateral or bilateral predominance and association with handedness but it is more common in males. there is no association of these creases with anomalies/diseases/syndromes. conclusively this work draws attention to the importance of undertaking parallel investigations on every socio-cultural human group or population wherever possible.
Prevalences of Simian, Sydney and Suwon Creases and their Association with Each Other, Body Sides, Handedness, Sex and Anomalies/Diseases/Syndromes in a Population of Central India Prevalencias de Pliegues Simiesco, de Sydney y de Suwon y su Asociación entre Ellos, Lados del Cuerpo, Dominancia Manual, Sexo y Anomalías/Enfermedades/Síndromes en una Población de la India Central
D. K Sharma,Vandana Sharma
International Journal of Morphology , 2011,
Abstract: The Simian and Sydney creases are variant palmar creases which have now drawn medical attention as their presence correlates strongly with numerous chromosomal anomalies and diseases. Works on these creases have been done on several human communities, racial and ethnic but no specific study is focussed out on the Indian populations. In this study 1000 Central Indian subjects (500 males and 500 females) aged between 5 to 70 years were randomly selected and examined by the authors. We found the prevalence of Simian, Sydney and Suwon creases in studied population of Central India is 14.4%, 3.6% and 2.4% respectively, which is a little higher than the figures for Asians and Caucasians claimed by earlier studies. There is no any association between these creases. The Simian crease is predominantly unilateral right side and associated with handedness. It is more common in males. The Sydney crease does not have unilateral or bilateral predominance and association with handedness but it is more common in females. The Suwon crease does not have unilateral or bilateral predominance and association with handedness but it is more common in males. There is no association of these creases with anomalies/diseases/syndromes. Conclusively this work draws attention to the importance of undertaking parallel investigations on every socio-cultural human group or population wherever possible. Los pliegues simiescos y de Sydney, son pliegues palmares variantes que en la actualidad han llamado la atención médica, ya que su presencia se relaciona estrechamente con numerosas anomalías cromosómicas y enfermedades. Investigaciones sobre estos pliegues se han realizado en diferentes comunidades humanas, raciales y étnicas, pero ningún estudio específico se centra sobre las poblaciones indígenas. En este estudio 1000 sujetos de la India central (500 hombres y mujeres 500) entre 5 y 70 a os fueron seleccionados al azar y examinados. Se encontró que la prevalencia de los pliegues Simiescos, de Sydney y de Suwon de la población estudiada es de 14,4%, 3,6% y 2,4% respectivamente, mayor que los porcentajes en asiáticos y caucásicos. No hay ninguna asociación entre estos pliegues. El pliegue simiesco es predominantemente unilateral derecho y se asocia con dominancia manual. Es más común en los hombres. El pliegue de Sydney no tiene predominio unilateral o bilateral, ni asociación con dominancia manual, pero es más común en las mujeres. El pliegue de Suwon no tiene predominio unilateral o bilateral, ni asociación con dominancia manual, pero es más común en los hombres. No existe ninguna as
RS-GIS Based Assessment of River Dynamics of Brahmaputra River in India  [PDF]
Archana Sarkar, R. D. Garg, Nayan Sharma
Journal of Water Resource and Protection (JWARP) , 2012, DOI: 10.4236/jwarp.2012.42008
Abstract: The Brahmaputra River is one of the largest alluvial rivers in the world characterized by frequent bank erosion leading to channel pattern changes and shifting of bank line. This study is aimed at quantifying the actual bank erosion/deposi- tion along the Brahmaputra River within India for a period of eighteen years (1990-2008). The entire course of Brah- maputra River in Assam from upstream of Dibrugarh up to the town Dhubri near Bangladesh border for a stretch of around 620 kms has been studied using an integrated approach of Remote Sensing and Geographical Information Sys- tem (GIS). The channel configuration of the Brahmaputra River has been mapped for the years 1990 and 2008 using IRS 1A LISS-I, and IRS-P6 LISS-III satellite images respectively. The analysis of satellite data has provided not only the information on the channel configuration of the river system on repetitive basis but also has brought out several sig- nificant facts about the changes in river morphology, stable and unstable reaches of the river banks and changes in the main channel. The results provide latest and reliable information on the dynamic fluvio-geomorphology of the Brah- maputra River for designing and implementation of drainage development programmes and erosion control schemes in the north eastern region of the country.
Role of saxagliptin as monotherapy or adjunct therapy in the treatment of type 2 diabetes
Morali D Sharma
Therapeutics and Clinical Risk Management , 2010, DOI: http://dx.doi.org/10.2147/TCRM.S7679
Abstract: le of saxagliptin as monotherapy or adjunct therapy in the treatment of type 2 diabetes Review (4741) Total Article Views Authors: Morali D Sharma Published Date May 2010 Volume 2010:6 Pages 233 - 237 DOI: http://dx.doi.org/10.2147/TCRM.S7679 Morali D Sharma Baylor College of Medicine, Houston, Texas, USA Abstract: Type 2 diabetes is associated with decreased incretin hormone response to an oral glucose load, and a progressive decline in postprandial glucagon-like peptide-1 (GLP-1) secretion. Incretin-based therapies offer a new option for treatment of type 2 diabetes. Saxagliptin, a potent, selective dipeptidyl peptidase-4 (DPP-4) inhibitor specifically designed for extended inhibition of the DPP-4 enzyme, causes increased endogenous GLP-1 concentration. In a phase 3 clinical trials program of 24 weeks duration, saxagliptin was studied in 6 multicenter, multinational, randomized, controlled studies and in combination with 3 of the most commonly administered oral antidiabetic drugs: metformin, glyburide and a thiozolidinedione (TZD). Saxagliptin provided significant reductions in hemoglobin HbA1c when given with metformin, glyburide, a TZD, or as monotherapy. Saxagliptin also reduced fasting plasma glucose and 2-hour post-prandial glucose in each of these studies, and was weight and lipid neutral. Saxagliptin was well tolerated and had a low risk of hypoglycemia when used as monotherapy.
Fixed point theorems without continuity of any mappings in dislocated quasi metric space
R. Sharma,D. Thakur
International Journal of Mathematical Analysis , 2013,
Abstract: The aim of this paper is to prove some common fixed point theorems fordislocated quasi-metric spaces. We point out that for the existence of fixed point,continuity of any mapping is not needed.
A Political-Economy of the U.S. Subprime Meltdown
Shalendra D. Sharma
Economic Analysis and Policy , 2009,
Abstract: What began as a downturn in the U.S. housing sector in mid-2007 soon mushroomed into a global financial crisis by September 2008. Why was the crisis triggered in the United States renowned for its resilient and innovative economic system? Why the crisis, which began with the implosion of a relatively small part of the U.S. housing market (the subprime mortgages) quickly morphed into a credit crunch, plunging the world economy in the worst financial crisis since the Great Depression? And, what explains the failure of both the market participants and public authorities to anticipate (at least initially) the depth and gravity of the crisis? In contrast to conventional explanations that see the crisis rooted in the procyclicality of the financial system, or the result of Wall Street greed and incompetence, this article provides a political-economy analysis of the complex series of events that lead to U.S. subprime meltdown. Specifically, the paper illustrates that the subprime crisis is fundamentally the result of massive regulatory failure in the United States. Although both market actors and regulators failed to properly assess the risks of complex assets, powerful lawmakers (both Republicans and Democrats) and regulators whose responsibility was to maintain due diligence against potentially destructive market failure, clearly failed in their responsibility.
Role of saxagliptin as monotherapy or adjunct therapy in the treatment of type 2 diabetes
Morali D Sharma
Therapeutics and Clinical Risk Management , 2010,
Abstract: Morali D SharmaBaylor College of Medicine, Houston, Texas, USAAbstract: Type 2 diabetes is associated with decreased incretin hormone response to an oral glucose load, and a progressive decline in postprandial glucagon-like peptide-1 (GLP-1) secretion. Incretin-based therapies offer a new option for treatment of type 2 diabetes. Saxagliptin, a potent, selective dipeptidyl peptidase-4 (DPP-4) inhibitor specifically designed for extended inhibition of the DPP-4 enzyme, causes increased endogenous GLP-1 concentration. In a phase 3 clinical trials program of 24 weeks duration, saxagliptin was studied in 6 multicenter, multinational, randomized, controlled studies and in combination with 3 of the most commonly administered oral antidiabetic drugs: metformin, glyburide and a thiozolidinedione (TZD). Saxagliptin provided significant reductions in hemoglobin HbA1c when given with metformin, glyburide, a TZD, or as monotherapy. Saxagliptin also reduced fasting plasma glucose and 2-hour post-prandial glucose in each of these studies, and was weight and lipid neutral. Saxagliptin was well tolerated and had a low risk of hypoglycemia when used as monotherapy.Keywords: saxagliptin, incretins, type 2 diabetes, DPP-4 inhibitors
Non Invasive Mechanical Ventilation
Dr U. D. Sharma
Indian Anaesthetists' Forum , 2004,
Abstract: Negative pressure ventilators (Tank and Cuirass ventilators) were the only non-invasive methods of assisting ventilation for many years mainly for ventilating large number of victims of Polio during their acute illness. In 1980s it was recognized that delivery of continuous positive airway pressure by close fitting nasal masks for treatment of obstructive sleep apnoea could also be used to deliver an intermittent positive pressure. This was followed by improvements in the interface and establishment of role of NIMV in patients of COPD. The use of NIMV has increased in last decade in various conditions to avoid complications of intubation.
Newer Vaccines-Need for Informed Choice
Taneja D,Sharma P
Indian Journal of Community Medicine , 2006,
Abstract:
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