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LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes
EP20282
Poster Title: LC-MS Approaches to Profiling of Non-Radiolabelled Metabolites in Response to Recent Regulatory Changes
Submitted on 19 Dec 2013
Author(s): Richard Clayton, Caroline Anderson, Brian Morrison and Lindsay Corfield
Affiliations: Covance
Poster Views: 1,664
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Poster Information
Abstract: The key aims of these regulatory guidelines are to:

Identify unique human metabolites. Characterise disproportionate human metabolites. Assess relative exposure of parent drug and its metabolites.

LC-MS approaches have become the methods of choice for these investigations. Identification and characterisation of metabolites relies on locating metabolites within a complex matrix and may be addressed using the performance of modern accurate mass instruments such as the Thermo LTQ Orbitrap.
Summary: Following publication of the FDA MIST guidelines and revision of ICH M3, there is increasing interest in obtaining metabolic profiling data at an early stage in the development of a drug. This has led to a requirement to estimate the relative abundance of metabolites in samples prior to the synthesis of the radiolabelled compound and from a wider range of studies.
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