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.