Clinical trials Microdosing

Yamane, N., Tozuka, Z., Sugiyama, Y., Tanimoto, T., Yamazaki, A., and Kumagai, Y. (2007). Microdose clinical trial Quantitative determination of fexofenadine in human plasma using liquid. J. Chromatogr. B 858 118-128. 

Clinical trials are divided into four phases. These are Phase I to Phase IV (Fig. 6.1). These trials are conducted with specihc purposes to evaluate the safety and effectiveness of the drug in defined population groups. A recent proposal is to conduct Phase 0 —a microdosing trial on subjects. Exhibit 6.4 provides more details on this new topic. 

European Medicines Evaluation Agency (EMEA) (2003). Position paper on non-clinical safety studies to support clinical trials with a single microdose. EMEA, London, UK. 

CPMP Position Paper on Von-clinical Safety Studies to Support Clinical Trials with a Single Microdose. July 2003... 

Especially in combination with alternative approaches such as toxicogenom-ics or a phase 0 clinical trial based on microdosing, fish embryo assays have a strong potential for reducing drug developmental costs in the near future.15-109 This is also demonstrated by a growing number of enterprises in which lead development and initial preclinical safety evaluation is performed with embryos... 

European Medicines Agency (EMEA), Position Paper on Non-clinical Safety Studies to Support Clinical Trials with a Single Microdose, 1, 2004. http //www.emea.europa.eu/ pdfs/human/swp/259902en.pdf... 

---