
Technetium-99m Pharmaceuticals
Preparation and Quality Control in Nuclear Medicine
By: Ilse Zolle (Editor)
Hardcover | 7 November 2006
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368 Pages
23.39 x 15.6 x 2.06
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Radioactive drug development is a multi-disciplinary task, therefore, in a concerted effort, dedicated scientists and experts from different fields of specialisation have contributed to this book. It is presented in two sections. Section 1 contains basic principles and methods used for analysis, information on the chemistry of technetium and on radiopharmaceuticals labelled with technetium-99m, the characteristics of the 99 Mo/99mTc-generator, of 'kits' and formulations for in-vitro labelling, and special safety aspects for in-vivo labelling of blood cells. Section 2 contains monographs of 99mTc-radiopharmaceuticals used in nuclear medicine. Each monograph includes information on the chemistry, formulation, commercial products and trade names, factors affecting in-vivo performance, clinical information on pharmacokinetics, as well as details concerning the clinical application and the radiation dose to patients.
Industry Reviews
From the reviews:
"This nicely organized and clearly illustrated book provides an up-to-date resource for radiopharmacists and nuclear medicine physicians who compound and prescribe 99mTc-labeled radiopharmaceuticals. Radiochemists and those concerned with regulatory affairs also will be interested, and the book could be used as a primary text in nuclear medicine training programs. This outstanding book fills a void and is the first compilation of its kind in many years. We recommend it with the highest enthusiasm." (Susan Z. Lever and John R. Lever, Journal of Nuclear Medicine, May, 2009)
Drug Safety | p. 1 |
Quality Control and Cost | p. 3 |
Quality Standards | p. 4 |
Quality Assurance | p. 4 |
Quality Control of Kit Products | p. 4 |
European Economic Community Directives and Regulations | p. 5 |
Technetium in Medicine | p. 7 |
[superscript 99m]Technetium Chemistry | p. 7 |
Technetium Compounds and their Structures | p. 8 |
Technetium(V) Complexes | p. 9 |
Technetium(IV), (III), and (I) Complexes | p. 17 |
[superscript 99m]Tc Labeling | p. 20 |
Technetium and Rhenium Tricarbonyl Core | p. 27 |
Bioconjugates Comprising the M(CO)[subscript 3] Core | p. 32 |
Technetium Coupled With Biologically Active Modules | p. 40 |
Introduction | p. 40 |
Factors Affecting In Vivo Performance | p. 41 |
Chelate Units in the Design of Target-Specific [superscript 99m]Tc Pharmaceuticals | p. 42 |
Search for Novel Tc Pharmaceuticals | p. 46 |
Stannous Chloride in the Preparation of [superscript 99m]Tc Pharmaceuticals | p. 59 |
Introduction | p. 59 |
Stannous Chloride: the Preferred Reducing Agent for Tc Pharmaceuticals | p. 61 |
Quality Assurance of Radiopharmaceuticals | p. 67 |
Introduction | p. 67 |
Definitions | p. 67 |
Quality Assurance | p. 67 |
Good Manufacturing Practice | p. 68 |
Pharmacopeias | p. 70 |
Approval for Marketing Authorization of a Radiopharmaceutical | p. 71 |
Quality Control | p. 71 |
Performance and Quality Control of the [superscript 99]Mo/[superscript 99m]Tc Generator | p. 77 |
The Equilibrium State | p. 78 |
Production of Molybdenum-99 | p. 79 |
Separation Methods | p. 79 |
Design of the Generator Column | p. 80 |
The Generator Eluate | p. 80 |
Performance of the [superscript 99]Mo/[superscript 99m]Tc generator system | p. 81 |
Elution Efficiency | p. 81 |
The Kinetics of Decay and Growth of the [superscript 99]Mo/[superscript 99m]Tc Generator | p. 82 |
Factors Affecting the Elution Yield | p. 85 |
Elution of Carrier [superscript 99]Tc | p. 85 |
Purity of Generator Eluate (European Pharmacopeia) | p. 86 |
Radionuclidic Purity | p. 86 |
Radiochemical Purity | p. 86 |
Chemical Purity | p. 87 |
pH of Eluate | p. 87 |
Methods and Results | p. 87 |
Determination of the Elution Efficiency | p. 87 |
Determination of the [superscript 99]Mo Content of the Eluate | p. 87 |
Determination of the Radiochemical Purity of the Eluate | p. 89 |
Determination of the Chemical Purity of the Eluate | p. 89 |
Conclusions | p. 90 |
Preparation of Technetium [superscript 99m]Tc Pharmaceuticals | p. 95 |
Introduction | p. 95 |
Physical Characteristics | p. 95 |
Chemical Characteristics | p. 95 |
Kit Preparation | p. 95 |
General Considerations | p. 96 |
Cold Kits | p. 96 |
[superscript 99m]Tc-Pertechnetate | p. 97 |
Incubation | p. 97 |
Quality Control | p. 97 |
Dispensing | p. 98 |
Lyophilization Technique for Preparing Radiopharmaceutical Kits | p. 9 |
History of the Lyophilization Technique | p. 99 |
Principles of Lyophilization | p. 100 |
Apparatus for Freeze-Drying | p. 101 |
The Drying Chamber | p. 101 |
The Ice Condenser | p. 101 |
The Refrigeration Unit | p. 101 |
The Vacuum Pump | p. 102 |
Cellular Labeling with [superscript 99m]Tc Chelates: Relevance of In Vitro and In Vivo Viability Testing | p. 103 |
Introduction | p. 103 |
Red Blood Cells | p. 103 |
Platelets | p. 108 |
White Blood Cells | p. 114 |
Stem Cells | p. 118 |
Conclusions | p. 118 |
Quality Control Methods of [superscript 99m]Tc Pharmaceuticals | p. 123 |
Determination of Chemical Purity | p. 123 |
Thin-Layer Chromatography | p. 123 |
Column Chromatography | p. 136 |
Electrophoresis | p. 143 |
Determination of Tin(II) | p. 144 |
Sterility Testing of Radiopharmaceuticals | p. 146 |
Problems in Applying European Pharmacopeia Test to Radiopharmaceuticals | p. 146 |
Recommendations for Sterility Testing of Radiopharmaceuticals | p. 147 |
Frequency of Testing | p. 148 |
Pyrogen Testing of Radiopharmaceuticals | p. 148 |
Recommendations for Endotoxin Determinations of Radiopharmaceuticals | p. 149 |
Other Tc Isotopes: [superscript 94m]Tc as a Potential Substitute in Positron Emission Tomography Investigations | p. 151 |
Introduction | p. 151 |
Methods of Production | p. 151 |
Methods of Separation | p. 152 |
The Rules Governing Medicinal Products for Human Use in the European Union | p. 155 |
European Economic Community Directives and Regulations | p. 155 |
Application for Marketing Authorization | p. 157 |
Industrial Production | p. 158 |
Marketing Authorization | p. 158 |
Sales and Distribution | p. 159 |
Pharmacovigilance | p. 159 |
Other Aspects | p. 159 |
SPC for Radiopharmaceutical Products | p. 160 |
The European Pharmacopeia | p. 161 |
General | p. 161 |
Monographs on Radiopharmaceuticals in the European Pharmacopeia | p. 162 |
Elaboration of New European Pharmacopeia Monographs on Radiopharmaceutical Preparations | p. 163 |
European Union Legislation Concerning New Drug Development | p. 165 |
European Commission Directives and Guidelines | p. 165 |
Clinical Trials | p. 166 |
CTA Requirements | p. 166 |
Monographs of [superscript 99m]Tc Pharmaceuticals | p. 173 |
[superscript 99m]Tc-Pertechnetate | p. 173 |
[superscript 99m]Tc-Labeled Human Serum Albumin | p. 181 |
[superscript 99m]Tc-Albumin (HSA) | p. 181 |
[superscript 99m]Tc-Albumin Macroaggregates (MAA) | p. 187 |
[superscript 99m]Tc-Albumin Microspheres (HAM) | p. 194 |
[superscript 99m]Tc-Labeled Colloids | p. 201 |
[superscript 99m]Tc-Labeled Microcolloids | p. 201 |
[superscript 99m]Tc-Tin Colloid (Size Range: 0.2-0.8 [Mu]m) | p. 201 |
[superscript 99m]Tc-Rhenium Sulfide Colloid | p. 207 |
[superscript 99m]Tc-Albumin Microcolloid | p. 213 |
[superscript 99m]Tc-Albumin Millimicrospheres | p. 218 |
[superscript 99m]Tc-Labeled Nanocolloids | p. 224 |
[superscript 99m]Tc-Rhenium Sulfide Nanocolloid | p. 224 |
[superscript 99m]Tc-Albumin Nanocolloid | p. 230 |
[superscript 99m]Tc-Labeled Myocardial Perfusion Agents | p. 237 |
[superscript 99m]Tc-MIBI (Methoxyisobutyl Isonitrile) | p. 237 |
[superscript 99m]Tc-Tetrofosmin | p. 245 |
[superscript 99m]Tc-Labeled Brain Perfusion Agents | p. 251 |
[superscript 99m]Tc-HMPAO (Hexamethylpropylene Amine Oxime) | p. 251 |
[superscript 99m]Tc-ECD (Ethyl Cysteinate Dimer) | p. 260 |
[superscript 99m]Tc-Labeled Leukocytes | p. 266 |
[superscript 99m]Tc-Labeled Bone Imaging Agents | p. 271 |
[superscript 99m]Tc-Pyrophosphate (PYP) | p. 271 |
[superscript 99m]Tc-Diphosphonates | p. 280 |
[superscript 99m]Tc-Labeled Renal Imaging Agents | p. 291 |
[superscript 99m]Tc-DMSA (Dimercaptosuccinic Acid) | p. 291 |
[superscript 99m]Tc-DPTA (Diethylenetriaminepentaacetate) | p. 297 |
[superscript 99m]Tc-EC (Ethylene Dicysteine) | p. 303 |
[superscript 99m]Tc-MAG[subscript 3] (Mercaptoacetyltriglycine) | p. 308 |
[superscript 99m]Tc-Labeled Hepatobiliary Agents | p. 315 |
[superscript 99m]Tc-IDA (Iminodiacetic Acid) Derivatives | p. 315 |
[superscript 99m]Tc-Labeled Peptides | p. 322 |
[superscript 99m]Tc-Depreotide | p. 322 |
[superscript 99m]Tc-Labeled Monoclonal Antibodies | p. 328 |
[superscript 99m]Tc-Arcitumomab | p. 328 |
[superscript 99m]Tc-Sulesomab | p. 333 |
Administration of Radioactive Substances Advisory Committee (ARSAC): radiation doses for children | p. 339 |
European Association of Nuclear Medicine (EANM): radiation doses for children (issued by the Pediatric Task Group of the EANM) | p. 340 |
Recommended Reading | p. 340 |
Scope of Cost B3 | p. 343 |
Table of Contents provided by Ingram. All Rights Reserved. |
ISBN: 9783540339892
ISBN-10: 3540339892
Published: 7th November 2006
Format: Hardcover
Language: English
Number of Pages: 368
Audience: Professional and Scholarly
Publisher: Springer Nature B.V.
Country of Publication: DE
Dimensions (cm): 23.39 x 15.6 x 2.06
Weight (kg): 0.64
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