Page 10 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

Contents ix

VetBooks.ir Postapproval Surveillance Activities 96 8. Toxicokinetics in Veterinary Toxicology
Overview of the CVM’s Pharmacovigilance
Deon van der Merwe, Ronette Gehring and
Program
96
Communication of Safety Information 99 Jennifer L. Buur
Animal Food 99 Introduction 133
References 100 Underlying Physiology 133
Absorption 133
Distribution 134
7. Regulatory Aspects for the Drugs and Biotransformation 134
Chemicals Used in Food-Producing Excretion 134
Animals in the European Union Empirical (Compartmental) Toxicokinetic
Models 135
´
Arturo Anadon, Marı ´a R. Martı ´nez-Larran ˜ aga, Introduction 135
Irma Ares and Marı ´a A. Martı ´nez Measures of Absorption 136
Volume of Distribution 136
Introduction 103
Clearance 136
Veterinary Medicinal Products Legislation 104
Marketing Authorization Procedures 104 Half-Life 136
Human Health Risks From Drug Residues Flip-Flop Kinetics 136
in Foods 106 Residues 136
Acute Toxicity Effects 106 Physiologically Based Toxicokinetics 137
Long-Term Chronic Effects Introduction 137
(Carcinogenesis) 108 Model Construction 137
Carryover of the Feed of Coccidiostats Parameter Estimation and Identifiability 140
and Other Medicated Feed 111 Model Validation 141
Minimum Required Performance Limits and Applications 141
Reference Point for Action 113 Concluding Remarks and Future Directions 142
Pesticide Substances/Residues From References 142
Consumption of Stockfeed Treated With
Agricultural Chemicals 113 9. Toxicological Testing: In Vivo and
Biocidal Substances Used in Animal In Vitro Models
Husbandry 114
Magda Sachana and Alan J. Hargreaves
Feed Additives Legislation 115
Technological Additives 117 Introduction 145
Sensory Additives 117 In Vivo Models in Toxicity Testing 145
Nutritional Additives 117 Introduction 145
Zootechnical Additives 118 Routes of Test Compound Administration 146
Comparative Setting Toxicological Standards Reproductive Toxicity Tests 147
for Food Safety 118 Developmental Toxicity Testing 148
Establishment of European Community Cutaneous Toxicity Testing 148
Maximum Residue Limits for Drugs Genotoxicity Testing 149
and Feed Additives 118 Carcinogenicity Tests 149
Maximum Residue Level 120 Neurotoxicity 149
Establishment of Codex Maximum Immunotoxicity 150
Residue Limits for Drugs and Feed Transgenic Animals in Toxicity Testing 150
Additives 123 In Vitro Models of Toxicity Testing 151
Changes in Calculation of MRLs 124 Introduction 151
United States of America: Food and Drug Types of Cell Culture System Used
Administration Tolerance Setting 126 in Toxicity Testing 151
Drug Withdrawal/Withholding Periods 127 Endpoint Determination for In Vitro Testing
Industrial Chemicals 127 Systems 153
Concluding Remarks and Future Directions 129 Concluding Remarks and Future Directions 157
References 129 References 158
Further Reading 131 Further Reading 161