@inbook{56875471, author={Markus Paulmichl, MD and Marc Maliepaard, PhD and Marisa Papaluca, MD and Christian Grimstein, PhD}, editor={Bertino, Joseph S. and DeVane, C. Lindsay and Fuhr, Uwe and Kashuba, Angela D. and Ma, Joseph D.}, title={Chapter 4. Regulatory Considerations in Pharmacogenomics at EMA and US FDA}, booktitle={Pharmacogenomics: An Introduction and Clinical Perspective}, publisher={The McGraw-Hill Companies}, address={New York, NY}, year={2013}, url={accesspharmacy.mhmedical.com/content.aspx?aid=56875471} }