RESEARCH STUDY OF MEDICINES USING THE HUMAN BODY AFTER HIS/HER DEATH-Reference-Cited by-同舟云学术

RESEARCH STUDY OF MEDICINES USING THE HUMAN BODY AFTER HIS/HER DEATH

Published:2021 Issue:11 Volume:74 Page:3103-3107
ISSN:0043-5147
Container-title:Wiadomości Lekarskie
language:en
Short-container-title:Wiad Lek

Author:

Antoniuk Olena І.¹,Vyshnyvetskyy Ivan I.²

Affiliation:

1. MINISTRY OF JUSTICE OF UKRAINE, KYIV, UKRAINE, UKRAINIAN ASSOCIATION FOR CLINICAL RESEARCH, KYIV, UKRAINE

2. BOGOMOLETS NATIONAL MEDICAL UNIVERSITY, UKRAINIAN ASSOCIATION FOR CLINICAL RESEARCH, KYIV, UKRAINE

Abstract

The aim of this paper is to determine the legal nature and basis for the research of medicines using the human body after establishing the fact of his/her biological death. Materials and methods: This research study is based on an analysis of the norms of international law and legislation of some states on the admissibility of the research of medicines using the human body after establishing the fact of his/her biological death. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. Conclusions: The possibility of organizing and conducting research using the human body after ascertaining the fact of his/her biological death as a scientific study distinguishes such studies from related types of medicines research, proposed standardization of these studies within the preclinical research of medicines, and examination of materials funds.

Publisher

ALUNA

Subject

General Medicine

Reference16 articles.

1. 1. Seyhan AA. Lost in translation: the valley of death across preclinical and clinical divide – identification of problems and overcoming obstacles. Translational Medicine Communications. 2019;4(18). doi.org/10.1186/s41231-019-0050-7.

2. 2. Gail AVan. Norman Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Is it Time to Rethink Our Current Approach? JACC: Basic to Translational Science 2019;4(7):845-854. doi.org/10.1016/j.jacbts.2019.10.008.

3. 3.. Andrade E.L, Bento A.F, Cavalli J et al. Calixto Non-clinical studies in the process of new medicines development – Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Braz. J. Med. Biol. Res. 2016;49(12). doi.org/10.1590/1414-431X20165646.

4. 4. Dirven H, Vist GE, Bandhakavi S et al. Performance of preclinical models in predicting medicines-induced liver injury in humans: a systematic review. Sci Rep. 2021;11(6403). doi.org/10.1038/s41598-021-85708-2.

5. 5. Gawai AA, Shaikh F, Gadekar M et al. A Review on: Phase ‘0’ Clinical Trials or Exploratory Investigational New Medicines. Turk J Pharm Sci. 2017;14(1):84-89. doi:10.4274/tjps.63935.