EU-Japan Float Criteria for Developing Drugs Using Block-Copolymer-Micelles

February 27, 2013
First-in-human studies of block-copolymer-micelle (BCM) drug products should establish sampling time points and sampling duration that quantify the time course of the nanotech products for total active substance, free active substance and metabolites, according to a joint EU-Japan reflection paper. Nonclinical data to consider in setting these parameters include pharmacokinetic (PK) parameters such as Cmax, half-life and AUC (total time under the concentration time curve) of BCM drugs for total active substance and free active substance in blood, plasma or serum, the paper says.
International Pharmaceutical Regulatory Monitor