Non-clinical Dose Formulation Analysis

Details in guidance, is it possible ?“Non viral vectors for delivery of transgenes. (…). Non- viral delivery of an expression construct employspharmaceutical formulation of the construct by exploiting the physic-chemical or colloidal properties,for example, SIZE, and SURFACE CHARGE conferred by the achieve site-specific or target deliveryof the construct. (…)”“The composition of the formulation used to deliver the construct should be supported by (..) in vivobiodistribution (…) in vivo biodistribution can be influenced by PARTICLE SIZE, the mean particle size aswell as the SIZE DISTRIBUTION should be characterized using an appropriate method (…) the STABILITYof the particles should be addressed. The INFLUENCE of pH (…) should be considered (…) Referenceshould be made with regard to the potential DEGRADATION product derived from the delivery vehicle(…) data should form the basis of (…) the STORAGE conditions (…)”NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF THE GENE TRANSFER MEDICINAL PRODUCTS. EMEA 2001www.filab.com.pl