Veterinary International Conference on Harmonization (VICH) Guidance Documents
- CVM GFI #63 - VICH GL1 - Validation of Analytical Procedures: Definition and Terminology
- CVM GFI #64 - VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance
- CVM GFI #73 - VICH GL3(R) - Stability Testing of New Veterinary Drug Substances
- CVM GFI #74 - VICH GL4 - Stability Testing of New Veterinary Dosage Forms
- CVM GFI #75 - VICH GL5 - Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products
- CVM GFI #89 - VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I
- CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
- CVM GFI #91 - VICH GL8 - Stability Testing for Medicated Premixes
- CVM GFI #85 - VICH GL9 - Good Clinical Practices
- CVM GFI #92 - VICH GL10(R) - Impurities In New Veterinary Drug Substances
- CVM GFI #93 - VICH GL11(R) - Impurities in New Veterinary Medicinal Products
- CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
- CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
- CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
- CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
- CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
- CVM GFI #99 - VICH GL17 - Testing of New Biotechnological/Biological Products
- CVM GFI #100 - VICH GL18 (R2) - Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
- CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
- CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
- CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
- CVM GFI #115 - VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies
- CVM GFI #116 - VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
- CVM GFI #117 - VICH GL24 - Management of Adverse Event Reports (AER's)
- CVM GFI #144 VICH GL27: Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
- CVM GFI #141 - VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing,
- CVM GFI #142 - VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
- CVM GFI #143 - VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
- CVM GFI #147 - VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat-Dose (90 Day) Toxicity Testing
- CVM GFI #148 - VICH GL32 - Developmental Toxicity Testing
- CVM GFI #149 - VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing
- CVM GFI #214 - VICH GL35 - Electronic Standards for Transfer of Data
- CVM GFI #159 - VICH GL36 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
- CVM GFI #160 - VICH GL37- Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
- CVM GFI #166 - VICH GL38 - Environmental Impact Assessment's (EIA's) for Veterinary Medicinal Products (VMP's) - Phase II
- CVM GFI #176 - VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
- CVM GFI #177 - VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product
- CVM GFI #185 - VICH GL43 -Target Animal Safety for Veterinary Pharmaceutical Products
- CVM GFI #198 - VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
- CVM GFI #205 - VICH GL46 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)
- CVM GFI #206 - VICH GL47 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies In Laboratory Animals
- CVM GFI #207 - VICH GL48 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods
- CVM GFI #208 - VICH GL49 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
- CVM GFI #219 - VICH GL51 - Statistical Evaluation of Stability Data
- CVM GFI #224 - VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study
- Supplement to CVM GFI #224 - VICH GL52 - Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52
- CVM GFI #225 - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations
- CVM GFI #232 - VICH GL54 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
- CVM GFI #243 - VICH GL56 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods
- CVM GFI #257 - VICH GL57 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species
- CVM GFI #259 - VICH GL58 - Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV