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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Xenotransplantation: The Future Bullet For Malady

Author: SARA JABEEN, BALAMURALIDHARA V
Abstract: Background & Objectives: Due to the shortage of organ donors around the globe most of the people are losing their life waiting for deceased organs this led to the emergence of xenotransplantation. The term xenotransplantation (xeno = alien; transplantation = relocate) consist of donor and acceptor which involves transfer of live cells, tissues, or organs from animal source into a human. Xenotransplantation benefits human life through multiple ways by Organ xenotransplants tissue xenotransplants, cellular xenotransplants. The research has shown that swine is the most acceptable animal in the process of organ, cells and tissue transplantations in humans. The main objective of this paper is to enlighten the researchers to make a scientific study on Xenotransplantation as a new concept to improve public health and save number of lives for which no alternative treatment is available. Methods: With the assistance of regulatory guidance document, the chances of transmission of porcine retrovirus (PERV) for which numerous scrutinising methods are available is best described in the released guidances. Interpretation and conclusion: Considering the patient and public health which may get affected due to the potential risk linked with xenotransplantation, to prevent such problem regulatory framework was enforced to assist the ongoing clinical trial. The current regulatory study highlights the distinct focus on Xenotransplantation by overseeing the regulatory comparison between USA and New Zealand and projects the concern taken by these countries to safeguard the public health.
Keyword: Regulatory Authorities, organ donors, xenotransplantation, Investigational New Animal Drug, New animal drug, Passive screening program, Active screening program
DOI: https://doi.org/10.31838/ijpr/2021.13.03.227
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