Microdosing and drug development: past, present and future.
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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 was 10 years ago and this review comprehensively explores the microdose concept from conception, over the past decade, up until the current date. AREAS COVERED: The authors define and distinguish the concept of microdosing from similar approaches. The authors review the ability of microdosing to provide exploratory pharmacokinetics (concentration-time data) but exclude microdosing using positron emission tomography. The article provides a comprehensive review of data within the peer-reviewed literature as well as the latest applications and a look into the future, towards where microdosing may be headed. EXPERT OPINION: Evidence so far suggests that microdosing may be a better predictive tool of human pharmacokinetics than alternative methods and combination with physiologically based modelling may lead to much more reliable predictions in the future. The concept has also been applied to drug-drug interactions, polymorphism and assessing drug concentrations over time at its site of action. Microdosing may yet have more to offer in unanticipated directions and provide benefits that have not been fully realised to date.
Clinical Trials, Phase I as Topic
Dose-Response Relationship, Drug
Guidelines as Topic
Published Version (Please cite this version)10.1517/17425255.2013.786042
Publication InfoLappin, Graham; Noveck, Robert; & Burt, Tal (2013). Microdosing and drug development: past, present and future. Expert Opin Drug Metab Toxicol, 9(7). pp. 817-834. 10.1517/17425255.2013.786042. Retrieved from https://hdl.handle.net/10161/11174.
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Assistant Professor of Psychiatry and Behavioral Sciences
Tal Burt, MD is a Board-Certified psychiatrist and clinical researcher trained in Israel, Italy, France, and the United States. After joining the faculty at the Department of Psychiatry at Columbia University, Dr. Burt joined Pfizer Inc., and then Eisai Pharmaceuticals, as Senior Medical Director with responsibilities in all phases of clinical research and development. He then joined Duke and was the founding director of the Investigational Medicine Unit (IMU) in Singapore and th
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Robert Joseph Noveck
Associate Professor of Medicine
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