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Human ADME Studies Come Early

Understanding which drug metabolites are formed in humans both qualitatively and quantitatively is of fundamental importance in the drug development process, especially if any of the formed metabolites are pharmacologically active or toxic. The new FDA guidance on Safety Testing of Drug Metabolites is particularly focused on situations where the safety of drug metabolites may need to be determined in non-clinical studies because these metabolites are either only identified in humans or are present at disproportionately higher levels in humans than in any of the animal species used during standard non-clinical toxicology testing (1).

 

METABOLISM OF DEVELOPMENT DRUGS

The guidance touches upon the complexities of such cases – for example, where only one species used in the toxicology studies provides insufficient exposure to such a metabolite.

Furthermore, when plasma contains parent plus one or two metabolites, this is a very different situation to one where the drug is metabolised to many metabolites, perhaps over a prolonged period of time – any one of which constitutes...

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The instigator and founder of Xceleron, Dr Colin Garner was previously Research Director and founder of Biocode Ltd, a monoclonal antibody diagnostics company funded originally by Shell Ventures (UK). He also founded and was MD of Microtest Research Ltd. Colin’s career has been spent bridging the gap between academic research and its commercial exploitation having set up the University of York’s first spin-out company in 1976. In addition to his commercial activities, Colin was the UK’s first Professor of Molecular Epidemiology and Director of the Jack Birch Unit for Environmental Carcinogenesis at the University of York. He was founding editor of Carcinogenesis and has published over 200 papers and reviews on the environmental causes of cancer. Colin was elected a Fellow of the Royal College of Pathologists in 1994 and awarded a DSc in 1995 by the University of London for his scientific contributions to the fields of cancer cause and prevention.

Dr Graham Lappin received his BSc in Biochemistry (1981) and PhD (1984) from the University of Westminster. He then spent two years at the University of Glasgow researching the anabolism of terpenoids in plant species. Following a period developing analytical methods for mass spectrometry, Graham joined ICI in Manchester in 1989. There he led a team of scientists researching into the metabolism of xenobiotics in laboratory animal species and later also managed the mass spectroscopy unit. He left in 1995 to join Covance Laboratories as a section manager in the metabolism and environmental chemistry department. In 2001, he joined Xceleron as Head of Research and Development, where he helped pioneer many applications of accelerator mass spectrometry, including human microdosing. Graham is a Fellow of the Institute of Biology and Royal Society of Chemistry in the UK and has served on the Institute of Biology’s Council as well as the Royal Society’s International Scientific Unions’ Committee.

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Dr Colin Garner
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Dr Graham Lappin
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