Nonclinical CTD Modules: What Goes in, Why and How?

10:15 AM - 10:40 AM

Writing the nonclinical CTD Modules requires in-depth knowledge of the nonclinical studies that should be described in these modules. The package of nonclinical studies is quite diverse in nature and partly depends on the drug under investigation. It ranges from a description of the compound's pharmacological mode of action and its beneficial activity against target disease, to studies which provide insight in the safety aspects and metabolism of the drug. These safety studies can again be subdivided into various groups, such as safety pharmacology studies, in vitro and in vivo toxicological, and pharmacokinetic studies. The writer should have knowledge on the interplay between the various types of studies and study aspects which will be important for the clinical investigators to consider for envisioning potential adverse effects of the drug in the clinical situation. This presentation will provide an overview of the various types of studies that will be part of the nonclinical package that has to be described in the CTD modules. Specifically for the safety studies, this presentation will explain their mutual connections, why they are included in the nonclinical modules, and which aspects are important to describe in the regulatory documentation. The presentation will also discuss how these studies are described in the general templates for the various study types in Module 2.6.