Journal of Radioanalytical and Nuclear Chemistry
Volume/Issue:
Volume 206: Issue 1
The role of radioisotope applications in regulatory affaits concerning registration of new drugs
Author:
A. Benakis University Medical Center Laboratory of Drug Metabolism, Department of Pharmacology Geneva (Switzerland)

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Pages:
91–105
Online Publication Date:
13 Aug 2005
Publication Date:
17 May 1996
Article Category:
Research Article
DOI:
https://doi.org/10.1007/bf02040046
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Abstract  

Although the original interest in labeled compounds was in order to conduct fundamental studies in pharmacology, a more compelling reason for their use soon became evident with the need to obtain metabolic and pharmacokinetic data required for registration of new drugs.A number of aspects of the protocol for registration of new drugs such as whole-body autoradiography, plasma and tissue protein binding etc, require the use of labeled drugs.The labeling of drugs for this purpose involves a number of problems of which the more important are: the choice of radioisotope, the choice of labeled position, the number of steps to obtain the relevant labeling position, the specific acitivity of the labeled compound, the radiochemical and chemical purity and stability, the purification techniques as well as the time required and cost of performing the synthesis of labeled drugs. A newer application of labeled compounds is that of the synthesis of labeled chemicals to be used for Positron Emission Tomography (PET), a very useful technique not only in neurology but also in metabolic and pharmacokinetic studies.

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Cover Journal of Radioanalytical and Nuclear Chemistry
Journal of Radioanalytical and Nuclear Chemistry
Print ISSN:
0236-5731
Online ISSN:
1588-2780

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Journal of Radionalytical and Nuclear Chemistry
Language English
Size A4
Year of
Foundation		 1968
Volumes
per Year		 1
Issues
per Year		 12
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 0236-5731 (Print)
ISSN 1588-2780 (Online)

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