Page 134 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition
P. 134

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://
   129   130   131   132   133   134   135   136   137   138   139