[F1 [F25.4. Specific requirements for tissue engineered products U.K.
5.4.1. Pharmacokinetic studies U.K.
Where conventional pharmacokinetic studies are not relevant for tissue engineered products, the biodistribution, persistence and degradation of the tissue engineered product components shall be addressed during the clinical development.
5.4.2. Pharmacodynamic studies U.K.
Pharmacodynamic studies shall be designed and tailored to the specificities of tissue engineered products. The evidence for the ‘ proof of concept ’ and the kinetics of the product to obtain the intended regeneration, repairing or replacement shall be provided. Suitable pharmacodynamic markers, related to the intended function(s) and structure shall be taken into account.
5.4.3. Safety studies U.K.
Section 5.3.3 shall apply.] ]