What’s in Module 5 of the CTD?
(Note: This post is part of a multi-part series on the CTD this fall)
Module 5 contains the clinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 5 and 6. Module 5 contains all the detailed reports for each clinical study performed. Module 5 is the Efficacy module, containing the human clinical trails that demonstrate the benefits and risks of taking the new drug. Studies included in this section are:
- Bioavailability and bioequivalence studies (known as biopharmaceutics studies),
- Studies using human biomaterials to understand pharmacokinetics, such as plasma protein binding or drug-drug interaction studies,
- Human Pharmacokinetic studies,
- Human pharmacodynamic studies, and
- Human safety and efficacy studies.
These last three roughly correspond to the phase 1, 2, and 3 trials for the drug, although the pharmacokinetic and pharmacodynamic subsections will present reports of studies in bot normal subjects and patients. Read more about the organization and contents of the clinical overview and summaries in module 2 and the clinical reports in module 5 in the M4E guidance. In my next post I’ll discuss the application lifecycle.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers
Follow the links below to read each part of the series.
Electronic Regulatory Submissions Part 1
Electronic Regulatory Submissions Part 2
Electronic Regulatory Submissions Part 3
Electronic Regulatory Submissions Part 4
Electronic Regulatory Submissions Part 5
Electronic Regulatory Submissions Part 6
Electronic Regulatory Submissions Part 7
Electronic Regulatory Submissions Part 8
Electronic Regulatory Submissions Part 9
Electronic Regulatory Submissions Part 10
Electronic Regulatory Submissions Part 12
Electronic Regulatory Submissions Part 13
Electronic Regulatory Submissions Part 14