Module 2.4 is a critical component of the Common Technical Document (CTD), specifically designed to provide a comprehensive summary of nonclinical (preclinical) study data. It bridges the detailed data presented in Module 4 with the concise overviews in the Quality and Clinical modules. At Medwisdom, we understand the strategic importance of Module 2.4 in regulatory submissions and its role in supporting product safety profiles.
This section includes summarized pharmacology, pharmacokinetics, and toxicology data obtained from nonclinical studies on animals and in vitro systems. It presents the results in a narrative, integrated format, allowing regulatory reviewers to quickly understand the scientific rationale behind the safety evaluation of a drug or biologic.
Key elements of Module 2.4 include:
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Overview of nonclinical findings relevant to pharmacodynamics (PD), pharmacokinetics (PK), and toxicology.
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Justification for dose selection in clinical trials based on animal studies.
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Risk assessments regarding reproductive toxicity, genotoxicity, and carcinogenic potential.
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Comparative discussions highlighting consistency or discrepancies across different study types.
At Medwisdom, our regulatory experts and scientific writers ensure that Module 2.4 is accurately aligned with ICH guidelines, clearly written, and formatted to meet global regulatory expectations. This enables pharmaceutical and biotech companies to present their nonclinical data with confidence and precision in their CTD submissions.
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