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European Biopharmaceutical Review

The Mounting Evidence for Microdosing

Drug development pipelines are plagued by increasing costs and decreasing productivity, so techniques that weed out poorly performing compounds early in development are urgently needed. Microdosing studies can potentially provide information about drug behaviour in humans before Phase I, but there have been concerns that such small doses do not reflect a drug’s activity at the therapeutic dose. Now there is growing evidence that microdosing studies are useful for many drug types.

The number of new drugs reaching the market has been falling over the last 20 years, while research and development costs have progressively increased. This is partly due to inefficiencies in the drug development process – only one in around 5,000 compounds entering drug development makes it from the bench to the bedside (1). Poorly performing drug candidates are discarded at all stages in the development process, but late stage failures are particularly expensive, since the drug has been developed through the preclinical and early clinical trial stages.

The most costly failure occurs when a drug reaches the market, but has to be withdrawn. It costs more than $800 million to develop a drug and more than $125 million to take a drug through Phases I, II and III. The costs increase at later stages, since a Phase III trial can involve thousands of patients spread across several different countries (2). If a drug fails at this point, the financial consequences will be considerable.

Early identification of drugs unlikely to succeed during clinical trials can create significant cost savings, improve pipeline productivity and mitigate risk. For example, the cost of an approved new drug would fall by 4.7 per cent if just 25 per cent of failures in Phase II were detected at Phase I instead (3).

INTRODUCING MICRODOSING

The risk of failure during the expensive clinical trial stages can be reduced by collecting important information about a drug’s behaviour before Phase I so that unpromising candidates can be identified early. One critical attribute of a drug is...

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Dr Graham Lappin graduated in Biochemistry in 1981 and gained his PhD in 1984. After post-doctorial research, he went into industry working for Zeneca and Covance Laboratories. He joined Xceleron in 2000 as Head of Research and is now Senior Director of Science and Technology. He has almost 30 years’ experience in the applications of tracer isotopes to xenobiotic and drug metabolism. He has published over 30 papers and one textbook. He is a Fellow of both the Institute of Biology and Royal Society of Chemistry.
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