Technetium-99m Pharmaceuticals

Preparation and Quality Control in Nuclear Medicine

By: Ilse Zolle (Editor)

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Hardcover | 7 November 2006

At a Glance

Hardcover
368 Pages

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23.39 x 15.6 x 2.06

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$328.55

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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)

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Non-Fiction Medicine Other Branches of Medicine Medical Imaging Radiology Science Chemistry Physics Applied Physics Medical Physics Pharmacology Medical Toxicology

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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.

Technetium-99m Pharmaceuticals

Preparation and Quality Control in Nuclear Medicine

At a Glance

Hardcover

Industry Reviews

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