Table 1.

Guidance on the use of healthy volunteers^a

The number of trials that a subject may take part in during any 12-month period will depend on the:

• Types of investigational medicinal product (IMP) and their half-lives

• Routes of administration of the IMP

• Frequency and duration of exposure to IMP

• Procedures involved

• Total volume of blood taken from the subject

• Amount of radioactivity (no more than 10 milliSievert).

In general, subjects should not receive an IMP systemically less than 3 months after the previous one

^aFrom Association of the British Pharmaceutical Industry (ABPI) guidelines for phase 1 clinical trials, 2007 [2]