Method for processing and analysing of scientific advice reports
A scoring table and a partly overlapping analysis table were designed to record and analyse the information on the non-clinical development program as present in scientific advice reports and corresponding provided documentation from the sponsor. Both tables consisted for three parts 1) general data and information regarding in vivo animal studies, 2) biodistribution studies and 3) tumourigenicity studies. For a coded descriptive the options are given in between brackets. For an open descriptive this is listed as ‘specified’ in between the brackets.