Browsing by Author "Burt, Tal"
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Clinical Research Environment in India: Challenges and Proposed Solutions.
Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh (J Clin Res Bioeth, 2014-11-01)India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed ... -
Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.
Burt, Tal; Gupta, Yogendra K; Mehta, Nalin; Swamy, Nagendra; Vishwas; Speers, Marjorie A (J Clin Res Bioeth, 2014-09-07)Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of ... -
Microdosing and drug development: past, present and future.
Lappin, Graham; Noveck, Robert; Burt, Tal (Expert Opin Drug Metab Toxicol, 2013-07)INTRODUCTION: Microdosing is an approach to early drug development where exploratory pharmacokinetic data are acquired in humans using inherently safe sub-pharmacologic doses of drug. The first publication of microdose data ... -
PARTAKE survey of public knowledge and perceptions of clinical research in India.
Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; Mv, Deepa; Alam, Sazid; Jain, Sarika; ... (10 authors) (PLoS One, 2013)BACKGROUND: A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently ... -
Pharmacogenomics in early-phase clinical development.
Burt, Tal; Dhillon, Savita (Pharmacogenomics, 2013-07)Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify ...