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Hello,
could any one suggest me about e-CTD fomat for a bioequivalence study
report.
in the ICH E3 compliance e-CTD report, under which sections we shall
include the bionalytical method validation and bioanalytical study
report.
i understand that all other appendices other than those in ICH E3
report shall be kept under section 16 as sub sections.
is there any specific guidelines for the complete representation of e-
CTD report including bioanalytical method validation and study reports.
any information is appreciable.
Regards,
Debbie.
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Dear Debbie,
<include the bionalytical method validation and bioanalytical study
report>>
The BA & MV reports will fall under m5-5314 section
<under section 16 as sub sections>>
The study report can be placed under m5312 section.The format of the
same will follow ICH E3 and all its appendices will be under section
16.0.
<>
ICH -
http://www.ich.org/cache/html/573-272-1.html
Comprehensive table of contents for ANDA submission (FDA) using eCTD -http://www.fda.gov/cder/regulatory/ersr/5640CTOC-v1.2.pdf
DBE summary data tables & the CTD (FDA)
http://www.fda.gov/cder/ogd/Summary_BioTables_CTD.htm
Guidelines for regular eCTD specifications (FDA) can be accessed at
http://www.fda.gov/cder/Regulatory/ersr/ectd.htm
Habeeb Ibrahim
Medical Writing
GVK BIO
Hyderabad, India
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