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Dear All,
Does any one know how to prepare 'inf' and 'dat' for Submissions in
the CTD Format for Health Canada.
Reference:
Page 38/41,
Appendix B: Computer Format for the Submission of Data for Comparative
Bioavailability
Studies
DRAFT GUIDANCE FOR INDUSTRY
Preparation of Comparative Bioavailability Information for Drug
Submissions in the CTD Format
Link:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/draft_ebauche_ctdbe-eng.php#two
Thank you,
Yogesh
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