Search Results - "Davis, Sanish"

Clinical trial footprint in BRICS: Improvements seen but needs further affirmative action by Davis, Sanish

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Declaration of Helsinki: Can it still serve as a North star for ethics in regulatory trials? by Davis, Sanish

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Role of investigational new drug committees in propelling the drug development ecosystem in India by Davis, Sanish

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Monitoring of approved studies: A difficult tightrope walk by Ethics Committees by Davis, Sanish

“…Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol…”
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Clinical trials and healthcare needs in India: A difficult balancing act but opportunities abound by Davis, Sanish

“…In the recent years, several initiatives have been undertaken by various departments of the government, for example, New Millenium Indian Technology Leadership…”
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Challenges and opportunities for sponsors in conducting clinical trials during a pandemic by Davis, Sanish, Pai, Seema

“…The COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges have arisen, from country/ state lockdowns, site closures due…”
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Cancer Trials Ecosystem in India-Ready for Prime Time? by Mankan, Arun K, Shankar, Abhishek, Limaye, Sewanti, Ajaikumar, B S, Nachane, Prajakta, Singh, Navneet, Dawkhar, Shekhar, Batra, Ullas, Bhosekar, Amol, Ganguly, Sandip, Gawli, Pramod, Debnath, Khokan, Padalalu, Vivek, Reddy, Prasanth, Sundaramoorthy, Shanthi, Naveen, K K, Bondarde, Shailesh, Kumar, Praveen, Davis, Sanish, Ramkissoon, Shakti H, Chacko, Raju Titus, Vidal, Laura, Chico, Isagani, Hegedus, Andrew, Gupta, Sudeep, Saini, Kamal S

“…Executing global clinical trials for cancer is a long, expensive, and complex undertaking. While selecting countries global studies, sponsors must consider…”
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Ethics committees and the changed clinical research environment in India in 2016: A perspective by Davis, Sanish, Sule, Poonam, Bughediwala, Murtuza, Pandya, Vrunda, Sinha, Shilpi

“…Introduction: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs…”
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Ethics of genomic research by Mathaiyan, Jayanthi, Chandrasekaran, Adithan, Davis, Sanish

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Embedding good clinical practice into investigator-initiated studies or trials by Davis, Sanish

“…[3] A review of the requirements for IIT funding approval by Pharmaceutical Industry shows that as a best practice once the IIT is approved, then investigator…”
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A pilot study of the association of pharmacokinetic and pharmacodynamic parameters of warfarin with the dose in patients on long‐term anticoagulation by Kulkarni, Uday P., Swar, Balkrishna D., Karnad, Dilip R., Davis, Sanish, Patwardhan, Anil M., Kshirsagar, Nilima A., Gogtay, Nithya J.

“…WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Warfarin is a widely used anticoagulant with a low therapeutic index. • There is wide interindividual variation in…”
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Evaluation of the activity of CYP2C19 in Gujrati and Marwadi subjects living in Mumbai (Bombay) by Panchabhai, Tanmay S, Noronha, Shaun F, Davis, Sanish, Shinde, Vishal M, Kshirsagar, Nilima A, Gogtay, Nithya J

“…Inherited differences in the metabolism and disposition of drugs, and genetic polymorphisms in the targets of drug therapy (e.g., receptors), can greatly…”
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