Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και Πρόσβαση
Library of the School of Health Sciences

2022-05-13

2022

Sakkas Dimitrios

Αδάμ Αδαμόπουλος, Επίκουρος Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ανδριανή Χαρπίδου, Ακαδημαϊκή Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Νικόλαος Κωστομητσόπουλος, Ειδικός Λειτουργικός Επιστήμονας Α’ Βαθμίδας, Υπεύθυνος Μονάδας Ζωικών Προτύπων, Ίδρυμα Ιατροβιολογικών Ερευνών Ακαδημίας Αθηνών

Πώς τα αποτελέσματα των προκλινικών δοκιμών -in vivo δοκιμές και μελέτες- μπορούν να γίνουν πιο αξιόπιστα και ρεαλιστικά για τις κλινικές μελέτες και δοκιμές, ώστε να οδηγηθούμε σε γρήγορη, ασφαλή και οικονομική ανάπτυξη νέων φαρμάκων;

Greek

How can the preclinical results become more reliable and realistic for clinical use in order to achieve safe, fast and less costly drug development?

This thesis undertakes the modern Reproducibility and Repeatability crisis of preclinical research under the spectrum of the strict regulatory framework as defined by the international drug associations such as FDA and EMA.
First, a brief historical overview of animal’s contribution on development of human life quality standards is presented in introductory chapter. The second half of this chapter includes the drug development process. To date, animals’ involvement in preclinical research of new drug development plays a key role in order to guarantee the safety of new molecules.
Next chapter presents the legislative framework under which FDA and EMA operate to validate the whole process. Approval of new drug application is required for every candidate in order to design a clinical study. For this purpose, animal preclinical studies are mandatory to be included in the application file. The international associations, i.e., FDA and EMA, have the obligation to overwatch the housing conditions of preclinical experiments and guarantee the safety of laboratory animals via guidelines, laws and directives such as Guide for the Care and Use of Lab Animals and the Directive 2010/63/EU.
Furthermore, the major causes and negative effects of Irreproducibility Crisis are analyzed in the third chapter. The inability of reproducible results and the failure to replicate certain experiments-methods has led to unnecessary and excessive use of laboratory animals, reagents and materials. As a result, drug development process becomes both time and cost- consuming.
After detailed analysis of the crisis and its effects, presentation of remedial measures is implemented. During the conduction of experiment and results extraction, every process and participant should act under full transparency conditions. Transparency is a key component to enhance the public opinion over animal experiments.
The last chapter of this thesis concentrates the major derived conclusions and key proposals in order to increase the reliability of preclinical research results on drug development process.

Health Sciences

Preclinical Research, Reproducibility, Repeatability, Drug Development

No

0

Yes

58

204

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https://pergamos.lib.uoa.gr/uoa/dl/object/3217529