Formatting of Bioequivalence Summary Tables 1. Plea se prov ide the se tabl es as pdf f iles a nd in MS Word. Plac e the MS Word fo rmat o f all th e table s in Module 2.7 and the pdf files in the appropriate eCTD/CTD locations. 2. Mar ins for the pa per shou ld be 1! for the to p and botto m and 1.2"! f or the lef t and rih t sides . #. $l l te %t s hou ld be Times &e' (oman 1). *. Please use the Default Table S t+le 'hen creatin t he tables 'hen the+ are cre ated in Microsoft, Word. -Select Menu TableTable $uto ormatTa ble &ormal0 ". Tabl e 1 Table * Ta ble 7 Ta ble and Ta bles 1) 13 shoul d be in P4(T ($5 T orient ation . 3. Tabl e 2 Tabl e # Tabl e " Tab le 3 Ta ble 6 shou ld be in $&DS C$P 8 orie ntat ion. Table 1 Submission Summary Drug Product Name Strength(s) !!licant Name ddress Point of "ontact Name ddress Tele!hone Number Fa# Number 4r please provide an electronic cop+ of orm #"39. This information is needed for a complete ;ioe<uivale nce revie' and althouh re<uired for the archival cop+ submitted to the $enc+ it is fre<uentl+ not readil+ available in the ;ioe<uivalence Submission. The Division of ;ioe<uivalence prefers that this information be submitted as a electronic orm #"39. 5f this is not possible then please complete Table 1.
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 1/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 2/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 3/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 4/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 5/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 6/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 7/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 8/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 9/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 10/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 11/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 12/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 13/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 14/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 15/16
8/12/2019 DBE Tables
http://slidepdf.com/reader/full/dbe-tables 16/16
Related Documents
