Microdosing: A critical assessment of human data

Malcolm Rowland

    Research output: Contribution to journalArticlepeer-review


    Ultrasensitive analytical methodologies have now made possible the ability to characterize the pharmacokinetics (PK) of compounds following administration to humans of a minute, subpharmacologic dose, a microdose. This has the potential to provide pre-IND information to help in early candidate selection, but only if such information is reasonably predictive of PK at pharmacologic doses. The published clinical data in this area are critically assessed and perspectives drawn. The place of microdosing, alone and coupled with other innovative methodologies, both pre-IND and during clinical development, is considered as a way forward to improve the efficiency and informativeness of drug development. © 2012 Wiley Periodicals, Inc.
    Original languageEnglish
    Pages (from-to)4067-4074
    Number of pages7
    JournalJournal of Pharmaceutical Sciences
    Issue number11
    Publication statusPublished - Nov 2012


    • Bioavailability
    • Biopharmaceutical drug disposition classification system (BDDCS)
    • Oral absorption
    • PET
    • Pharmacokinetics
    • Physiological model


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