S. Department of Health and Human Services et al., 2006). This first study will involve limited human exposure and extreme caution.
Most significantly, the study itself has to be based on sound scientific principles with a thorough knowledge of the properties of the chemical, and the potential results on the human subject. Standard clinical safety evaluations will include serial assessment of patient symptoms, physical signs, and clinical laboratory tests amongst other tests monitoring possible adverse effects. These tests will be of sufficient duration in order to catch potential negative effects. Safety hazards for patients and health care workers during and after administration of the radio labeled product will also be identified, evaluated and appropriately managed.
Finally, as prescribed by Section 505(d) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(d)), adequate tests must be taken on the drug first before applying to a human individual. The drug must be FDA approved, before sponsor is allowed to proceed.
4) micro dosing: its benefits.
Since the drug can potentially be lethal, it is important that a repeat-dose pattern be applied (e.g. Of 14-28 days duration) with the patient being monitored throughout. This also prevents possible adverse effects occurring from accumulation of drug or from long-term use. In this way, the amount of radioactive material administered to human subjects will...
Department of Health and Human Services Food and Drug Administration et al., 2004). In fact, micro dose studies are designed not to induce pharmacological effect.
In a more practical sense, a drug can fail unnecessarily by employing inappropriate doses. Consequently, in addition to the cost saving results, micro dosing also enables rational risk management and decision making regarding properties of drug by making sure that the proposed drug is safe and efficacious in procuring intended results, as well as by evaluating which candidates are a positive match for the product (Farde et al., 2007)
References
Farde, L. et al., 2007 Using Positron Emission
Tomography (PET) microdosing. Focus, The Organisation for Professionals in Regulatory Affairs,1-8
U.S. Department of Health and Human Services et al. (2006). Guidance for Industry, Investigators, and Reviewers Office of Training and Communication, http://www.fda.gov/cder/guidance/index.htm
U.S. Department of Health and Human Services Food and Drug Administration et al. (2004). Guidance for Industry Developing Medical Imaging Drug and Biological Products Division of Drug Information HFD-240 http://www.fda.gov/cder/guidance/index.htm.
