Serono Geref Phase IV dose-optimization study should focus on effect of multiple injections, FDA says.

SERONO GEREF DOSE-OPTIMIZATION STUDY SHOULD FOCUS ON MULTIPLE INJECTION EFFECTS, FDA advises the Norwell, Mass.- based company in a Sept. 26 approval letter. FDA is asking Serono to "conduct a dose-ranging study in children with growth hormone deficiency which will include a pharmacokinetic/pharmacodynamic characterization of sermorelin using population analysis."