Documentary Support for Preclinical Studies in vivo in Accordance with the Principles of Good Laboratory Practice

INTRODUCTION. Currently, the Eurasian Economic Union (EAEU) lacks guidelines for documenting preclinical studies. At the same time, proper registration of raw data is necessary to confirm the quality of the preclinical results obtained.

AIM. This study aimed at introducing a documentation procedure for preclinical studies that would cover documents from the initial study application to the final report and provide for preclinical data transfer to the marketing authorisation dossier.

MATERIALS AND METHODS. The authors opted for information analysis as the method of research. All recommendations for documenting preclinical studies were formulated in accordance with the EAEU Good Laboratory Practice (GLP) requirements applicable to the medicinal product lifecycle and the work of preclinical study sites using experimental animals.

RESULTS. The general EAEU recommendations for the conduct of animal studies are not sufficient to achieve adequate quality of preclinical studies. This article proposes a procedure for complete documentation of preclinical studies, with all documents following the documentation requirements of the EAEU GLP for each study stage. When developing the necessary forms and documents, each study site should operate under its own quality management system and consider the preclinical study specifics on a case-by-case basis. The preparation of any given document should ensure compliance with the GLP principles and guarantee the completeness and integrity of the data obtained.

CONCLUSIONS. Study sites can implement the proposed documentation procedure to design and conduct preclinical studies in accordance with the regulatory requirements that determine the role and responsibilities of the study director and the conduct of inspections by the quality assurance unit.

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