(Note: This post is part of a multi-part series on the CTD this fall)

Module 4 contains the nonclinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 4and 6, respectively. Module 4 contains all the detailed reports for each nonclinical study performed. The majority of these studies are in vivo (in life) studies conducted in animals, but wherever possible in vitro (in a test tube) studies are substituted. Years of studies have shown that mammalian systems are similar across species and can be predictive of effects in other species, particularly with respect to the safety of the drug. That’s why this module is referred to as the Safety module. The safety studies fall under 3 types:

1. Pharmacology – the beneficial action of the drug on the body
2. Pharmacokinetics- the action of the body on the drug
3. Toxicology – the negative effect of the drug on the body

The regulatory reviewers evaluate this data to confirm the predicted risks (and the nonclinical evidence of benefits) of taking the drug that are presented in the nonclinical summaries. Read more about the organization and contents of the nonclinical overview and summaries in module 2 and the nonclinical reports in module 4 in the M4S guidance. In the next post we’ll review the contents of Module 5, which supports the actual observations of risks and benefits in human studies.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

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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 11

Electronic Regulatory Submissions Part 12

Electronic Regulatory Submissions Part 13

Electronic Regulatory Submissions Part 14

Electronic Regulatory Submissions Part 15

Electronic Regulatory Submissions Part 16