Writing scientific reviews
The DOCLINX team provides comprehensive services for preparing scientific reviews and summaries for Module 2 — Summary of the Common Technical Document.
Module 2 is a mandatory part of the registration dossier (Common Technical Document - CTD) for a medicinal product and consists of the following documents:
- 2.1. Table of Contents for Modules 2-5
- 2.2. CTD Introduction
- 2.3. Quality Overall Summary
- 2.4. Nonclinical Overview
- 2.5. Clinical Overview
- 2.6. Nonclinical Summary
- 2.7. Clinical Summary
2.1. Table of Contents for Modules 2-5
This section of the module presents the contents of the documentation on quality, safety, and efficacy of the medicinal product included in Modules 2- 5.
2.2. CTD Introduction
Information on the pharmacological group, mechanism of action, and proposed clinical use of the medicinal product should be presented.
2.3. Quality Overall Summary
The Quality Overall Summary should provide an overview of information related to chemical, pharmaceutical, and biological data.
Special attention should be paid to key critical parameters and issues related to quality aspects, as well as providing justification in cases where relevant requirements and guidelines are not met. This document should cover issues and describe relevant data that are presented in detail in Module 3.
2.4. Nonclinical Overview
A comprehensive and critical assessment of nonclinical studies of the medicinal product in animals and in vitro should be provided, as well as a discussion and justification of the research strategy when deviating from relevant requirements.
An assessment of impurities and degradation products of the medicinal product should be included, along with their potential pharmacological and toxicological effects, except for biological medicinal products. Any differences in chirality, chemical form, and purity of compounds used in nonclinical studies and in the medicinal product to be manufactured should be considered.
For herbal and biological medicinal products, it is necessary to evaluate the comparability of the product used in nonclinical studies, clinical trials, and the medicinal product to be registered.
Any new excipient is subject to a separate safety assessment.
It is necessary to identify the properties of the medicinal product proven in nonclinical studies, as well as present the significance of safety results for the planned clinical use of the medicinal product.
2.5. Clinical Overview
The Clinical Overview should contain a critical analysis of the clinical data included in the summary and Module 5. Information on the method of clinical development of the medicinal product should be presented, including study design, decisions made regarding the study, and the course of the studies.
A brief overview of clinical study data should be presented, including important limiting factors, as well as an assessment of the benefit-risk ratio based on the conclusions of clinical studies, justification for the proposed dose and indications for use based on the obtained clinical data on efficacy and safety, and an evaluation of how the general characteristics of the medicinal product, instructions for medical use, and other approaches can optimize benefits and limit risks.
All questions regarding efficacy and safety that arose during the development process and were not explained should be addressed.
2.6. Nonclinical Summary
The nonclinical summary should be presented based on the actual results of pharmacological, pharmacokinetic, and toxicological studies conducted on animals in vitro, in text format and in tables in the sequence presented below, with an introductory part:
- 2.6.1. Pharmacology Written Summary
- 2.6.2. Pharmacology Tabulated Summary
- 2.6.3. Pharmacokinetics Written Summary
- 2.6.4. Pharmacokinetics Tabulated Summary
- 2.6.5. Toxicology Written Summary
- 2.6.6. Toxicology Tabulated Summary
2.7. Clinical Summary
A detailed summary of clinical information on the study of the medicinal product included in Module 5 should be presented with factual data. The summary should include the results of all biopharmaceutical studies, clinical pharmacology studies, as well as studies on clinical efficacy and safety. A brief overview of individual studies should be provided. Clinical information in the form of a summary should be presented in a specific sequence of parts (with a list of scientific sources used):
- 2.7.1. Summary of Biopharmaceutic Studies and Associated Analytical Methods
- 2.7.2. Summary of Clinical Pharmacology Studies
- 2.7.3. Summary of Clinical Efficacy
- 2.7.4. Summary of Clinical Safety
- 2.7.5. References
- 2.7.6. Synopsis of Individual Studies
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