Search Results - "Gogtay, Nithya J"

Recruitment and retention of the participants in clinical trials: Challenges and solutions by Chaudhari, Nayan, Ravi, Renju, Gogtay, Nithya, Thatte, Urmila

“…Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the…”
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The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial - A critical appraisal by Rajan, Sujeet, Gogtay, Nithya, Konwar, Mahanjit, Thatte, Urmila

“…The Global Initiative for Asthma (GINA) recently released their updated Global Strategy for Asthma Management and Prevention Guide (2019). The pocket guide for…”
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Age-dependent sex bias in clinical malarial disease in hypoendemic regions by Pathak, Sulabha, Rege, Mayuri, Gogtay, Nithya J, Aigal, Umesh, Sharma, Surya Kant, Valecha, Neena, Bhanot, Gyan, Kshirsagar, Nilima A, Sharma, Shobhona

“…Experimental models show a male bias in murine malaria; however, extant literature on biases in human clinical malaria is inconclusive. Studies in hyperendemic…”
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Quantitative Proteomics Analysis of Plasmodium vivax Induced Alterations in Human Serum during the Acute and Convalescent Phases of Infection by Ray, Sandipan, Patel, Sandip K., Venkatesh, Apoorva, Chatterjee, Gangadhar, Ansari, Naziya N., Gogtay, Nithya J., Thatte, Urmila M., Gandhe, Prajakta, Varma, Santosh G., Patankar, Swati, Srivastava, Sanjeeva

“…The radial distribution of Plasmodium vivax malaria burden has evoked enormous concern among the global research community. In this study, we have investigated…”
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Reporting of randomized controlled trials: Will it ever improve? by Gogtay, Nithya

“…Poor adherence is also seen with other guidelines such as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, STrengthening the Reporting…”
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Investigator-initiated studies: Challenges and solutions by Konwar, Mahanjit, Bose, Debdipta, Gogtay, Nithya, Thatte, Urmila

“…Investigator-initiated studies (IISs) help by generating data on effectiveness and safety of a drug in the real-world setting and attempt to answer questions…”
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Regulatory requirements for clinical trials in India: What academicians need to know by Gogtay, Nithya J, Ravi, Renju, Thatte, Urmila M

“…The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching,…”
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A two-year evaluation of the minutes of Investigational New Drug committee meetings by Raj, Jeffrey, Gogtay, Nithya, Thatte, Urmila

“…Introduction: The Investigational New Drug (IND) committee advises the Drug Controller General of India on matters pertaining to clinical trials (CTs) of IND…”
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Proteomic analysis of Plasmodium falciparum induced alterations in humans from different endemic regions of India to decipher malaria pathogenesis and identify surrogate markers of severity by Ray, Sandipan, Kumar, Vipin, Bhave, Amruta, Singh, Vaidhvi, Gogtay, Nithya J., Thatte, Urmila M., Talukdar, Arunansu, Kochar, Sanjay K., Patankar, Swati, Srivastava, Sanjeeva

“…India significantly contributes to the global malaria burden and has the largest population in the world at risk of malaria. This study aims to analyze…”
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Association between genetic polymorphisms of CYP2C9 and VKORC1 and safety and efficacy of warfarin: Results of a 5 years audit by Biswas, Mansij, Bendkhale, Shital R., Deshpande, Siddharth P., Thaker, Saket J., Kulkarni, Dwarkanath V., Bhatia, Shobna J., Rajadhyaksha, Anjali G., Gogtay, Nithya J., Thatte, Urmila M.

“…Genetic polymorphisms of CYP2C9 and VKORC1 play major role in pharmacokinetics and pharmacodynamics of warfarin, respectively. Purpose of our study was to…”
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An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals by Bose, Debdipta, Nasta, Shagun, Ravi, Renju, Thatte, Urmila, Gogtay, Nithya

“…Background: A conflict of interest (COI) in publication exists when the primary interest of publication is influenced by a secondary interest (financial or…”
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Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India by Chaturvedi, Mansi, Gogtay, Nithya J, Thatte, Urmila M

“…India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not…”
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An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018) by Konwar, Mahanjit, Maurya, Mitesh, Nishandar, Tushar, Thatte, Urmila, Gogtay, Nithya

“…Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a…”
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Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018 by Shetty, Nayana, Salvi, Rachana, Thatte, Urmila, Gogtay, Nithya

“…Introduction: The Clinical Trials Registry of India (CTRI) that initially permitted retrospective registration moved to mandatory prospective registration of…”
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An audit of minutes of Subject Expert Committee meetings as a metric to assess the clinical research roadmap of India by Shetty, Parvan, Gogtay, Nithya, Thatte, Urmila

“…Background: In January 2015, the Drugs Controller General of India approved the formation of 25 Subject Expert Committees [SEC] to aid the office of the…”
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Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit by Bose, Debdipta, Saha, Shruti, Saxena, Unnati, Kesari, Harshad, Thatte, Urmila, Gogtay, Nithya

“…Introduction: A key determinant of the success of any study is the recruitment and subsequent retention of participants. Screen failure and dropouts impact…”
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Low-dose emicizumab prophylaxis in patients with severe hemophilia A: a retrospective study bringing new hope for our patients by Patil, Rucha, Shanmukhaiah, Chandrakala, Gogtay, Nithya J., Pandey, Puloma, Patil, Kirti, Jijina, Farah, Madkaikar, Manisha

“…Low-dose emicizumab can potentially offer a cost-effective treatment option in persons with hemophilia A, especially in developing countries. To compare the…”
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A prospective study to assess the association between genotype, phenotype and Prakriti in individuals on phenytoin monotherapy by Thaker, Saket J., Gandhe, Prajakta P., Godbole, Charuta J., Bendkhale, Shital R., Mali, Nitin B., Thatte, Urmila M., Gogtay, Nithya J.

“…Genetic polymorphisms in drug metabolizing enzymes (DMEs) impart distinct drug metabolizing capacity and a unique phenotype to an individual. Phenytoin has…”
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Economic burden of beta-thalassaemia major receiving hypertransfusion therapy at a public hospital in Mumbai by Uchil, Ashwija, Muranjan, Mamta, Gogtay, Nithya J

“…Background Treating beta-thalassaemia major may entail high costs with considerable out-of-pocket expenditure. Therefore, determination and valuation of the…”
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Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases by Nishandar, Tushar, Birajdar, Amit, Gogtay, Nithya, Thatte, Urmila

“…Purpose: The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional Ethics Committees (IECs). Rule 122DD of the Drugs and…”
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