Search CORE

1 research outputs found

The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process

Author: A Al Mesned
A Goel
A Suchanek
AC Cartwright
BR Kuhnert
Drug Information Association DIA.
E Fritz
eSubmission.
European Medicines Agency EMA.
European Medicines Agency EMA.
European Medicines Agency EMA.
European Medicines Agency EMA.
European Medicines Agency.
G Gensinger
Guidance for industry: providing regulatory submissions in electronic format—human pharmaceutical product applicationsrelated submissions using the eCTD specifications.
H Emoto
I Liquent
International Conference on Harmonisation ICH.
International Conference on Harmonisation ICH.
International Conference on Harmonisation ICH.
International Conference on Harmonisation.
IQ Pharma
J Bendtsen
J Molzon
J Schnitzler
JA Molzon
K Menges
K Menges
L Benning
L Goater
M Perez
M Pothiawala
MM Lakkis
NR Katz
P Kershaw
Porsche Consulting.
R Haan De
S Belkum Van
S Gens
S Gens
S Harmsen
S Järmann
S Scrace
T Buxton
T Felgate
Thomson Corporation.
Thomson Reuters.
Thomson Scientific.
UNICUS.
US FoodDrug Administration FDA.
V Ventura
W Hamilton
World Health Organization.
Publication venue: 'SAGE Publications'
Publication date
Field of study

core

core