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Regulatory Considerations in Veterinary Toxicology Chapter | 6 101
VetBooks.ir FDA, 2016c. Guidance for Industry: Action Levels for Poisonous or www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance
Enforcement/GuidanceforIndustry/UCM207941.pdf.
(accessed
Deleterious Substances in Human Food and Animal Feed. ,https://
30.05.17.).
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory
Information/ucm077969.htm#afla. (accessed 30.05.17.).
FDA, 2017. Consumer Complaint Coordinators. ,https://www.fda.gov/ FDA/CVM, 2015d. Guidance for Industry #208 (VICH GL49(R))
Studies to Evaluate the Metabolism and Residue Kinetics of
safety/reportaproblem/consumercomplaintcoordinators/default.htm. Veterinary Drugs in Food-Producing Animals: Validation of
(accessed 30.05.17.). Analytical Methods Used in Residue Depletion Studies. ,https://
FDA/CVM, 2001. Freedom of Information Summary: Baytril (enrofloxa- www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance
cin) Antibacterial Tablets. ,https://www.fda.gov/downloads/Animal Enforcement/GuidanceforIndustry/UCM207942.pdf. (accessed
Veterinary/Products/ApprovedAnimalDrugProducts/FOIADrug 30.05.17.).
Summaries/UCM326939.pdf. (accessed 30.05.17.). FDA/CVM, 2016a. Draft Revised Guidance for Industry #3 - General
FDA/CVM, 2009a. Guidance for Industry #185(VICH GL43) Target Principles for Evaluating the Human Food Safety of New Animal
Animal Safety for Veterinary Pharmaceutical Products. ,https:// Drugs Used In Food-Producing Animals. ,https://www.fda.gov/
www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance downloads/AnimalVeterinary/GuidanceComplianceEnforcement/
Enforcement/GuidanceforIndustry/ucm052464.pdf. (accessed GuidanceforIndustry/UCM052180.pdf. (accessed 30.05.17.).
30.05.17.). FDA/CVM, 2016b. Report A Problem. ,https://www.fda.gov/Animal
FDA/CVM, 2009b. Guidance For Industry #149 (VICH GL33) Veterinary/SafetyHealth/ReportaProblem/default.htm. (accessed
Studies to Evaluate the Safety of Residues of Veterinary Drugs in 30.05.17.).
Human Food: General Approach to Testing. ,https://www.fda.gov/ FDA/CVM, 2016c. Dear Doctor Letters. ,https://www.fda.gov/
downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055433.
Guidance htm. (accessed 30.05.17.).
forIndustry/UCM052521.pdf. (accessed 30.05.17.). FDA/CVM, 2017a. Minor Use/Minor Species. ,https://www.fda.gov/
FDA/CVM, 2011a. Guidance for Industry #85 (VICH GL9) Good AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinor
Clinical Practice. ,https://www.fda.gov/downloads/AnimalVeterinary/ Species/default.htm. (accessed 30.05.17.).
GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052417. FDA/CVM, 2017b. From an Idea to the Marketplace: The Journey of an
pdf. (accessed 30.05.17.). Animal Drug through the Approval Process. ,https://www.fda.gov/
FDA/CVM, 2011b. Guidance for Industry #205 (VICH GL46) Studies AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm219207.
to Evaluate the Safety of Residues of Veterinary Drugs in Human htm. (accessed 30.05.17.).
Food: Metabolism Study to Determine the Quantity and Identify the Gaylor, D.W., Kodell, R.L., 1980. Linear interpolation algorithm for low
Nature of Residues (MRK). ,https://www.fda.gov/downloads/ dose risk assessment of toxic substances. J. Environ. Pathol.
AnimalVeterinary/GuidanceComplianceEnforcement/Guidancefor Toxicol. 4, 305 312.
Industry/UCM207939.pdf. (accessed 30.05.17.). Hampshire, V.A., Doddy, F.M., Post, L.O., et al., 2004. Adverse drug
FDA/CVM, 2013. Guidance for Industry #159 (VICH GL36(R)) Studies event reports at the United States Food and Drug Administration
to Evaluate the Safety of Residues of Veterinary Drugs in Human Center for Veterinary Medicine. JAVMA. 225 (4), 533 536.
Food: General Approach to Establish a Microbiological ADI. ,https:// Ramirez, C.J., Minch, J.D., Gay, J.M., et al., 2011. Molecular genetic
www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance basis for fluoroquinolone-induced retinal degeneration in cats.
Enforcement/GuidanceforIndustry/UCM124674.pdf. (accessed Pharm. Gen. 21, 66 75.
30.05.17.). USDA-APHIS, 2017. Common Questions about Veterinary Biologics.
FDA/CVM, 2014. Drug Indexing. ,https://www.fda.gov/Animal ,http://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-
Veterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ biologics/ct_vb_pel_faqs. (accessed 30.05.17.).
ucm070206.htm. (accessed 30.05.17.). US Environmental Protection Agency, 2017. Pesticides. ,https://www.
FDA/CVM, 2015a. What We Do. ,https://www.fda.gov/AboutFDA/ epa.gov/pesticides. (accessed 30.05.17.).
CentersOffices/OfficeofFoods/CVM/WhatWeDo/default.htm. (accessed US Government Publishing Office, 2017. Electronic Code of Federal
30.05.17.). Regulations. ,https://www.ecfr.gov/. (accessed 30.05.17.).
FDA/CVM, 2015b. Draft Guidance for Industry #232 (VICH GL54) VICH, 2017. (International Cooperation on Harmonisation of Technical
Studies to Evaluate the Safety of Residues of Veterinary Drugs in Requirements for Registration of Veterinary Medicinal Products).
Human Food: General Approach to Establish an Acute Reference ,http://www.vichsec.org/. (accessed 30.05.17.).
Dose (ARfD). ,https://www.fda.gov/downloads/AnimalVeterinary/ WHO, 2017b. Safety Monitoring of Medicinal Products: Guidelines for
GuidanceComplianceEnforcement/GuidanceforIndustry/UCM448430. Setting Up and Running a Pharmacovigilance Centre. ,http://apps.
pdf. (accessed 30.05.17.). who.int/medicinedocs/en/d/Jh2934e/14.html. (accessed 30.05.17.).
FDA/CVM, 2015c. Guidance for Industry #207 (VICH GL48(R)) World Health Organization (WHO), 2017a. Pharmacovigilance. ,http://
Studies to Evaluate the Metabolism and Residue Kinetics of www.who.int/medicines/areas/quality_safety/safety_efficacy/pharm-
Veterinary Drugs in Food-Producing Animals: Marker Residue vigi/en/. (accessed 30.05.17.).
Depletion Studies to Establish Product Withdrawal Periods. ,https://