Developing drugs is a long and expensive process – on average it takes 10-12 years to get a drug to market at a cost of some $800M to $1B per marketed drug. While the pharmaceutical industry expenditure on R&D is exponentially rising (the latest estimate is $50 billion/year in the USA alone) the number of drugs being approved by the FDA has been falling since the peak in the mid-90s. This unsustainable situation is affecting patients, regulators and the pharma industry alike. The FDA is so concerned that they issued a White Paper known as the Critical Path Document in which they argued that a new development tool kit was needed if drug development efficiency was to be improved. One potential new tool to speed drug development is accelerator mass spectrometry (AMS). The availability of smaller AMS instruments is leading to their increasing use in drug development. AMS has a range of applications and potential applications in human drug metabolism and pharmacokinetic (PK) studies including (1) microdosing or human Phase 0 studies (2) conversion of high dose to low dose human radioactive mass balance studies (3) absolute bioavailability studies (4) absorption, metabolism and excretion studies of biomolecules including proteins, peptides and DNA. We have developed novel methods of taking drugs into humans using AMS detection methods. This presentation will discuss how AMS is being used in each of these clinical scenarios. Data will be reported on the CREAM trial, a pharma industry supported collaborative program on microdose versus pharmacological dose pharmacokinetics which demonstrates just how useful AMS will be in drug development.
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See more of AMS in Low Dose Bioscience Workshop
See more of The 10th International Conference on Accelerator Mass Spectrometry (September 5-10, 2005)