What Is Module 2.4? A Guide to the Nonclinical Summary Section
What is Module 2.4 Nonclinical Summary
It is the integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation of the pharmaceutical other than Human (i.e., Animals). If the drug products contain any novel excipients, then the safety of novel excipients should be established.
What Sections Should Be Included in Module 2.4 Nonclinical Summary
The following sections should be covered in Module 2.4 Nonclinical summary:
- Overview of the nonclinical testing strategy
- Pharmacology
- Pharmacokinetics
- Toxicology
- Integrated overview and conclusions
- List of literature references
For Format of Module 2.4 Nonclinical summary, kindly connect with the mail id: info@medwisdom.in
Why Module 2.4 Nonclinical Summary is Necessary for Marketing Authorization Submission
This section aims to determine the safe human use of pharmaceuticals by analysing data from pharmacology, pharmacokinetics, and toxicology. These data will be included in labelling of Pharmaceuticals.
How to Write the Module 2.4 Nonclinical Summary
The Module 2.4 nonclinical summary should be designed based on the guideline: The common technical document for the registration of pharmaceuticals for human use: safety – m4S(R2) nonclinical overview and nonclinical summaries of module 2 organisation of module 4
(https://www.ich.org/page/ctd).
How Medwisdom Lifesciences Can Assist You With Preparation of Module 2.4 Nonclinical Summary
The Medwisdom Lifesciences assist in the following:
- Search of Research Article
- Preparation of Module 2.4 Nonclinical summary
- Review of prepared Module 2.4 Nonclinical summary
- Gap analysis
- Suggestion of Labelling updates
FAQs
Marketing Authorization Holder: Companies that produce pharmaceutical products (Investigational drug / New drugs / or Generic drugs). They need Module 2.4 Nonclinical summary for preparation of CTD/eCTD file for submission with Regulatory Agencies (Like USFDA, EMEA, TGA, SFDA, Swissmedic).
Collection of Research data, Preparation and Technical Review: 2 to 5 days per molecule
- Collection of Research Data
- Searching of Data base to collect the Research Article (Example: PubChem[](https://pubchem.ncbi.nlm.nih.gov/), Drug bank[](https://go.drugbank.com/), ChEMBL (https://www.ebi.ac.uk/chembl etc.)
- Interpretation of the data
- Finding and Cross-linking with the quality aspects of the pharmaceutical, and the implications of the nonclinical findings for the safe use of the pharmaceutical (i.e., as applicable to labelling)
- Preparation of Overview/summary of all finding as per designed format of Module 2.4 Nonclinical summary based on guideline
For Format of Module 2.4 Nonclinical summary, kindly connect with the mail id: info@medwisdom.in
