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Purchase Benefits
What is included with this book?
List of Figures | p. xiii |
List of Tables | p. xv |
About the Editors | p. xvii |
Workshop Participants | p. xix |
Foreword | p. xxi |
Acknowledgments | p. xxv |
Introduction | p. 1 |
References | p. 3 |
Uses and Inputs of Veterinary Medicines in the Environment | p. 7 |
Introduction | p. 7 |
Veterinary Medicine Use | p. 7 |
Parasiticides | p. 8 |
Antibacterials | p. 8 |
Coccidiostats and Antiprotozoals | p. 10 |
Antifungals | p. 10 |
Aquaculture Medicines | p. 10 |
Hormones | p. 10 |
Growth Promoters | p. 10 |
Other Medicinal Classes | p. 11 |
Pathways to the Environment | p. 11 |
Emissions during Manufacturing and Formulation | p. 11 |
Aquaculture | p. 12 |
Agriculture (Livestock Production) | p. 13 |
Companion and Domestic Animals | p. 14 |
Disposal of Unwanted Drugs | p. 15 |
Summary | p. 16 |
References | p. 17 |
Environmental Risk Assessment and Management of Veterinary Medicines | p. 21 |
Introduction | p. 21 |
Veterinary Medicines in Regulatory Perspective | p. 23 |
Legislation, Scope, and Past Guidelines for Environmental Risk Assessment (ERA) of Veterinary Medicines | p. 23 |
United States | p. 24 |
European Union | p. 25 |
Japan | p. 26 |
Australia | p. 26 |
Canada | p. 26 |
Current Guidelines: VICH and the VICH-EU Technical Guidance Document (VICH-EU-TGD) | p. 27 |
Refinement of Veterinary Medicinal Product (VMP) Risk Assessments | p. 33 |
Metabolism and Degradation | p. 33 |
Combination Products | p. 35 |
Refinement of Environmental Exposure Predictions | p. 36 |
Probabilistic Risk Assessment of Veterinary Medicines | p. 36 |
Case Study of a Probabilistic Risk Assessment for Dung Fauna | p. 37 |
Risk Management | p. 41 |
Risk Mitigation Measures within Product Authorization or Approval | p. 42 |
Risk Assessment and Management beyond Authorization or Approval | p. 44 |
Communication Challenge | p. 44 |
Incidence Reporting and Pharmacovigilance | p. 47 |
Retrospective Risk Assessment | p. 49 |
Postmarket Monitoring and Remediation | p. 51 |
Monitoring Endpoints | p. 51 |
References | p. 52 |
Exposure Assessment of Veterinary Medicines in Aquatic Systems | p. 57 |
Introduction | p. 57 |
Sources of Veterinary Medicines in the Aquatic Environment | p. 58 |
Treatments Used in Agriculture | p. 58 |
Treatments Used in Aquaculture | p. 61 |
Experimental Studies into the Entry, Fate, and Transport of Veterinary Medicines in Aquatic Systems | p. 62 |
Aquatic Exposure to Veterinary Medicines Used to Treat Livestock | p. 62 |
Leaching to Groundwater | p. 63 |
Movement to Surface Water | p. 63 |
Predicting Exposure | p. 65 |
Comparison of Modeled Concentrations with Measured Concentrations | p. 66 |
Aquaculture Treatments | p. 73 |
Inputs and Fate of Marine Aquaculture Treatments | p. 75 |
Freshwater Aquaculture | p. 76 |
Modeling Exposure from Aquaculture Treatments | p. 77 |
Conclusions | p. 89 |
References | p. 91 |
Assessing the Aquatic Hazards of Veterinary Medicines | p. 97 |
Introduction | p. 97 |
Protection Goals | p. 98 |
Approaches to Assess Effects of Veterinary Medicines | p. 98 |
Current Methods of Assessing Aquatic Effects for Risk Assessment | p. 98 |
Lower Tier Approaches | p. 99 |
Higher Tier Testing | p. 99 |
Limitations to Current Approaches | p. 101 |
Novel Approaches to Aquatic Effects Assessment | p. 102 |
Use of Chemical Characteristics, Target Organism Efficacy Data, Toxicokinetic Data, and Mammalian Toxicology Data | p. 102 |
Use of Ecotoxicogenomics in Ecological Effects Assessment | p. 108 |
Application Factors and Species Sensitivities | p. 110 |
Effects of Veterinary Medicines in the Natural Environment | p. 113 |
Episodic Exposures | p. 114 |
Matrix Effects | p. 114 |
Metabolites and Degradates | p. 115 |
Mixtures | p. 116 |
Enantiomer-Specific Hazard | p. 117 |
Sorption to Sediment | p. 118 |
Assessing Effects on Communities | p. 119 |
Conclusions | p. 121 |
References | p. 122 |
Exposure Assessment of Veterinary Medicines in Terrestrial Systems | p. 129 |
Introduction | p. 129 |
Absorption and Excretion by Animals | p. 130 |
Fate during Manure Storage | p. 134 |
Releases to the Environment | p. 136 |
Factors Affecting Dissipation in the Farm Environment | p. 137 |
Dissipation and Transport in Dung Systems | p. 137 |
Dissipation and Transport in Soil Systems | p. 138 |
Biotic Degradation Processes | p. 138 |
Abiotic Degradation Processes | p. 140 |
Sorption to Soil | p. 141 |
Bound Residues | p. 141 |
Uptake by Plants | p. 143 |
Models for Estimating the Concentration of Veterinary Medicine in Soil | p. 143 |
Intensively Reared Animals | p. 144 |
Pasture Animals | p. 148 |
PEC Refinement | p. 148 |
Research Needs | p. 149 |
References | p. 149 |
Assessing the Effects of Veterinary Medicines on the Terrestrial Environment | p. 155 |
Introduction | p. 155 |
Considerations Unique to Veterinary Medicines | p. 155 |
Routes of Entry | p. 155 |
Additional Safety Data Available in the Dossier | p. 156 |
Residue Data and Detoxification by the Target Animal Species | p. 156 |
Protection Goals | p. 157 |
Tiered Testing Strategy | p. 160 |
Justification for Existing Testing Methods | p. 160 |
Use of Indicator Species | p. 160 |
Short-Term and Sublethal Effects Tests | p. 163 |
Tier A Testing | p. 163 |
Physicochemical Properties | p. 163 |
Fate | p. 164 |
Microorganisms | p. 164 |
Plants | p. 165 |
Earthworms | p. 165 |
Collembolans | p. 166 |
Dung Fauna | p. 166 |
Tier B Testing | p. 168 |
Tier C Testing | p. 169 |
Mesocosm and Field Testing | p. 169 |
Testing of Additional Species | p. 170 |
Monitoring Studies | p. 170 |
Calculation of PNEC Concentrations and Use of Assessment Factors | p. 171 |
Metabolite Testing in Tiers A and B | p. 172 |
Secondary Poisoning | p. 173 |
Bound Residues | p. 174 |
Alternative Endpoints | p. 175 |
Modeling Population and Ecosystem Effects (e.g., Bioindicator Approaches) | p. 176 |
Research Needs | p. 177 |
References | p. 177 |
Workshop Conclusions and Recommendations | p. 181 |
Workshop Conclusions | p. 181 |
Workshop Recommendations | p. 184 |
Index | p. 187 |
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The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.