Medwisdom

Non Clinical Summary Overview

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.

Module 2.4 Nonclinical Summary

What is Section to Be Included in Module 2.4 Nonclinical Summary

The following section 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).

Other Information

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:

Who Needs Module 2.4 Nonclinical Summary Services?

  1. Marketing Authorization Holder: Companies that produces pharmaceuticals products (Investigational drug/New drugs/ or Generic drugs). They need Module 2.4 Nonclinical summary for preparation for CTD/eCTD file for submission with Regulatory Agencies (Like USFDA, EMEA, TGA, SFDA, Swissmedic).

What Is the Timeline for Preparation of Module 2.4 Nonclinical summary?

  • Collection of Research data, Preparation and Technical Review: 2 to 5 days per molecule

What is the Quotation/charges for the Module 2.4 Nonclinical Summary?

For Quotation, kindly share the product list on the mail id: info@medwisdom.in.

What is Scope of Services (Medwisdom)

  1. Collection of Research Data
  2. 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.)
  3. Interpretation of the data
  4. 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)
  5. 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

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