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CTD (CMC (QbD/PAT (ICH Q8,9,10), Immediate release film coated, Powder…
CTD
CMC
QbD/PAT
ICH Q8,9,10
Immediate release film coated
Powder for oral suspension
Concentrate for solution for injection
CQA
ICH Q 6a
ICH Q1a R2
ICH
3.P.2 of the dossier
Modules
Module 1-regional
Module 2
Module 3
Module 4
Module 5
eCTD-brief
Introduction
CTD impact on dossier prep
Conclusion for both integrated
1600 WORDS
GMP
CTD triangle include