Title
The impact of early human data on clinical development: There is time to win
Author
Swart, P.
Lozac'h, F.
Simon, M.
van Duijn, E.
Vaes, W.H.
Publication year
2016
Abstract
Modern accelerator mass spectrometry (AMS) methods enable the routine application of this technology in drug development. By the administration of a (14)C-labelled microdose or microtrace, pharmacokinetic (PK) data, such as mass balance, metabolite profiling, and absolute bioavailability (AB) data, can be generated easier, faster, and at lower costs. Here, we emphasize the advances and impact of this technology for pharmaceutical companies. The availability of accurate intravenous (iv) PK and human absorption, distribution, metabolism, and excretion (ADME) information, even before or during Phase I trials, can improve the clinical development plan. Moreover, applying the microtrace approach during early clinical development might impact the number of clinical pharmacology and preclinical safety pharmacology studies required, and shorten the overall drug discovery program.
Subject
Life
MSB - Microbiology and Systems Biology
ELSS - Earth, Life and Social Sciences
Biomedical Innovation
Healthy Living
Pharmacology
Humans
Development
To reference this document use:
http://resolver.tudelft.nl/uuid:fb91760d-ea00-4197-8fbd-411adb403bba
DOI
https://doi.org/10.1016/j.drudis.2016.03.012
TNO identifier
871581
Source
Drug Discovery Today, 21 (6), 873-879
Document type
article