Module 18 - Drug Device Combinations and Other Technologies

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PHASE 0 – MICRODOSING

 A small number of human volunteers take doses of experimental new drugs that are just 1/100 of therapeutic dose so there is little risk of toxicity, in order to obtain early useful PK information

 Majority of the major pharmaceutical companies have taken this approach

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PHASE 0 – MICRODOSING

 It is conducted as an interim step between preclinical and Phase 1 studies  In the USA microdose studies are part of what is called ‘Exploratory IND’ studies, see FDA Guidance, January 2006 http://www.fda.gov/downloads/drugs/guidancecompliancere gulatoryinformation/guidances/ucm078933.pdf

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