CTD

Question 1

CTD?

Answer 1

Designed tp provide a coomin format between Europe, USA, and japen for the techical documentation inclduing in an application for the registration of a human phrmaceutical product

Question 2

Objectives and advantages of the CTD?

Answer 2

Reduce time and resources due to the common format which provides the necesary infomation
the manufacturer know where to plave the information, whereby the reviews know where to find the information , leading to potentially decrease time to market

Question 3

Advantges of the eCTD?

Answer 3

Organisation of the documents within the XML file and quick access
Verification of the integrity of the documents by integrating the MD5 checksum
Avoid duplicate files within the dossier

Question 4

Disadvantges of the eCTD?

Answer 4

Expensive software solutions
time consuming manual creation
conversion iof existing internal processes

Question 5

how many modules do the CTD have?

Answer 5

5 modules

Question 6

Moduel 1

Answer 6

Administrative information and prescibing information

Question 7

Moduel 2

Answer 7

Overviews and summaries of Modules 3-5

Question 8

Module 3

Answer 8

quality(pharmaceutical documentation

Question 9

Module 4

Answer 9

Non-clinical reports (pharmacology/toxicology

Question 10

Module 5

Answer 10

Clinical study report