The first sentence states that all publications be provided in one PDF file. Please clarify that each publication should be in a PDF file and all publications should be stored in one folder, rather than all publications combined into one PDF file. The guidance should specify that only critical animal data should be submitted in the proposed format. Population Pharmacokinetic Data overlaps with several folders. Please clarify the placement of this data.
Industry recommends it be placed in either a subfolder for population or a separate folder.
In this case, the patient is assigned a new patient number. Therefore, the patient would not necessarily have a unique number throughout the entire application. The programs and code will not be very useful to the Agency for data that is submitted according to the Content Of Specific Data Sets section because industry's internal databases probably won't match the format, field names and databases described in this section. The guidance requests mapping of a blank case report form to the corresponding elements in he database, a data definition table including codes and decodes, and inclusion of the data definition table in SAS transport format. Some of our codes are quite large and would be difficult to include in a column of a table.