Microdosing and drug development: past, present and future.
Abstract
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.
Type
Journal articleSubject
Administration, IntravenousAdministration, Oral
Animals
Clinical Trials, Phase I as Topic
Databases, Factual
Dose-Response Relationship, Drug
Drug Interactions
Guidelines as Topic
Humans
Pharmaceutical Preparations
Pharmacokinetics
Positron-Emission Tomography
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https://hdl.handle.net/10161/11174Published Version (Please cite this version)
10.1517/17425255.2013.786042Publication Info
Lappin, 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Tal Burt
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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