Preclinical studies in development of therapeutic radiopharmaceuticals - the critical approach for successful clinical application

Janevik-Ivanovska, Emilija (2018) Preclinical studies in development of therapeutic radiopharmaceuticals - the critical approach for successful clinical application. In: 7th Balkan Congress of Nuclear Medicine, 9-12 May 2018, Sarajevo, BiH.

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Abstract

The goal of this presentation is to discuss how development of therapeutic radiopharmaceuticals - the critical approach for successful clinical application.
The most important critters before to start preclinical investigation, are:
• High target activity and concentration including affinity and specificity, absence of biological barriers (i. e. endothelium, blood brain barrier,...) and stable labeling of compound
• Low background activity, that comprehend non- specific accumulation, circulating or interstitial activity and renal or hepatic elimination
• Signal amplification as cell trapping, enzymatic conversion and “Reporter” radioactive molecules. Preclinical studies for therapeutic radiopharmaceuticals
should be designed to assess:
• The in vivo stability of the radionuclide complex • The animal biodistribution of the radionuclide • The potential chemical toxicity
• The radiation exposure of tissues.
Data required to establish preclinical safety of radiopharmaceuticals include
• In vitro target/receptor profiling including pharmacodynamics
• Pharmacokinetics
• Potential chemical toxicity including antigenicity
• Radiation exposure of tissues
• Late radiation toxicity
• The dose evoking pharmacologic activity or antigenicity, and
• The minimum radioactivity dose needed for satisfactory imaging.

Item Type: Conference or Workshop Item (Lecture)
Subjects: Medical and Health Sciences > Clinical medicine
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Emilija Janevik
Date Deposited: 06 Feb 2019 08:05
Last Modified: 06 Feb 2019 08:05
URI: https://eprints.ugd.edu.mk/id/eprint/21489

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