Microdosing and drug development: past, present and future

Lappin, Graham and Noveck, Robert and Burt, Tal (2013) Microdosing and drug development: past, present and future. Expert Opinion on Drug Metabolism and Toxicology, 9 (7). pp. 817-834. ISSN 1742-5255

Full content URL: http://dx.doi.org/10.1517/17425255.2013.786042

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Item Type:Article
Item Status:Live Archive

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. © 2013 Informa UK, Ltd.

Keywords:atenolol, caffeine, carbamazepine, celiprolol, clarithromycin, diazepam, digoxin, diphenhydramine, enalapril, fexofenadine, fosdevirine, losartan, metformin, metoprolol, midazolam, nicardipine, paracetamol, phenazone, phenobarbital, propafenone, quinidine, raltegravir, sumatriptan, telmisartan, tenofovir, tolbutamide, unindexed drug, verapamil, warfarin, zidovudine, area under the curve, dose response, drug bioavailability, drug classification, drug clearance, drug efficacy, drug mechanism, drug metabolism, drug microdose, drug penetration, drug solubility, human, liver clearance, nonhuman, peer review, plasma concentration-time curve, positron emission tomography, review
Subjects:B Subjects allied to Medicine > B200 Pharmacology, Toxicology and Pharmacy
Divisions:College of Science > School of Pharmacy
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ID Code:11580
Deposited On:16 Aug 2013 15:47

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