The expanding utility of microdosing

Lappin, Graham (2015) The expanding utility of microdosing. Clinical Pharmacology in Drug Development, 4 (6). pp. 401-406. ISSN 2160-763X

Full content URL: http://dx.doi.org/10.1002/cpdd.235

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Abstract

The concept of microdosing has been around for more than a decade. It consists of the subpharmacologic administration of an investigational drug (1 of the pharmacologic dose or 100μg, whichever is lower) to human subjects to attain pre-phase 1 pharmacokinetics (PK) in humans. The major concern with microdosing has been the potential for nonlinear PK between doses, but methods are emerging to evaluate the potential for nonlinear PK prior to conducting a study. Currently, approximately 80 of drugs tested by the oral route and 100 by the intravenous route have exhibited scalable PK between a microdose and a therapeutic dose (within a factor of 2). Over the past few years microdosing has found utility in pediatrics, protein-based therapeutics, and a new application known as intra-arterial microdosing that focuses more on localized pharmacodynamics than PK. Compared with other PK predictive methods, such as physiologically based pharmacokinetic modeling, allometry, and in vitro-in vivo extrapolation, microdosing appears to provide a significantly better understanding of PK prior to phase 1, albeit within what is currently a limited database. © 2015, The American College of Clinical Pharmacology.

Keywords:Microdosing, Intra-arterial microdosing, Dose linearity, Phase-0, Protein microdosing, Pediatric microdosing, JCNotOpen
Subjects:B Subjects allied to Medicine > B200 Pharmacology, Toxicology and Pharmacy
Divisions:College of Science > School of Pharmacy
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ID Code:20223
Deposited On:30 Mar 2016 14:16

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