The use of accelerator mass spectrometry to obtain early human ADME/PK data

Lappin, Graham and Garner, R. Colin (2005) The use of accelerator mass spectrometry to obtain early human ADME/PK data. Expert Opinion on Drug Metabolism and Toxicology, 1 (1). pp. 23-31. ISSN 1742-5255

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There is an increasing recognition within the pharmaceutical industry of the importance of the ADME studies in drug registration. Consequently, there has been a drive in recent times to conduct the ADME studies as early as possible in the development programme. There are, however, regulatory barriers, particularly in the administration of radiotracers to human volunteers, which place limitations on the timing of the ADME studies. Accelerator mass spectrometry (AMS), a technology new to the pharmaceutical industry, is an ultrasensitive technique for measuring tracers such as 14C. Using AMS, it is possible to lower the radioactive dose administered to humans to a point where many regulatory authorities consider it insignificant. With the removal of the regulatory hurdles, ADME data can be obtained much earlier in the development process. Tracers such as 14C can be administered in minute amounts in the first in man studies (Phase I), or even in a preregulatory study known as microdosing (or human Phase 0). AMS also enables other studies such as absolute bioavailability to be conducted earlier if required. © Ashley Publications Ltd 2005.

Keywords:accelerator mass spectrometry, AMS, bioavailability, human Phase 0, microdosing, Radiotracer
Divisions:College of Science > School of Pharmacy
ID Code:8237
Deposited On:24 Mar 2013 16:12

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