List of Guidelines for Toxicology Animal Studies

1. ICH Guidelines for Pharmaceuticals: Safety (S) and Multidisciplinary (M3, M4, M7) 

2. (a) OECD Guidelines for the Testing of Chemicals:- Human Health Effects (Section 4) Test Numbers 404, 405, 408, 413, 414, 425, 432, 442B,443, 471, 474, and 476/490 - 

    (b) Effects on Biotic Systems (Section 2) Test Numbers 202, 203, and 207.

    (c) Acute Toxicity Study (Some Distinct Calculation  Methods)

 3. US EPA Human Health and Ecological Risk Assessment Guidelines: 

     - Risk Assessment Guidance for Superfund (RAGS): Part A  

     - Guidelines for Carcinogen Risk Assessment

     - Guidance for Applying Quantitative Data to Develop Data-Derived ExtrapolationFactors for Interspecies and Intraspecies Extrapolation 

     - 1998 Guidelines for Ecological Risk Assessment

4. National Research Council (NRC). 2009. Science and Decisions: Advancing Risk Assessment (Silver Book). National Academy Press, Washington, D.C.

5. National Research Council of the National Academies of Science. 2007 Toxicity Testing in the 21st Century: A Vision and a Strategy (2007). Washington, DC: The NationalAcademies Press.  

6. US FDA Guidance for Industry:

 - The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB) (CDRH/CBER, December 2017)

 - Guidance for Industry: Nonclinical Studies for the Safety Evaluation of PharmaceuticalExcipients (PDF - 230KB) (CDER/CBER, May 2005)

 - CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of VeterinaryDrugs in Human Food: General Approach to Establish an Acute Reference Dose(ARfD) (PDF - 100KB) 

- Guidance for Industry: Safety of Nanomaterials in Cosmetic Products 

- Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance forIndustry (PDF - 115KB) 

- Food Additives: Frequently Asked Questions about GRAS (October 2016)

 - Food Additives: Toxicological Principles for the Safety Assessment of FoodIngredients: Redbook 2000 (July 2007) 

- Food Additives: Estimating Dietary Intake of Substances in Food (August 2006) 

- Pharmacology / Toxicology: Estimating the Maximum Safe Starting Dose in InitialClinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702KB) Final Guidance 07/28/05

 - Pharmacology / Toxicology: Carcinogenicity Study Protocol Submissions (PDF - 29KB) Final Guidance 05/22/02 

- Pharmacology / Toxicology: Safety Testing of Drug Metabolites: Guidance for Industry (Revision 1; Nov 2016)

7. Klaassen, C.D., Ed.: Casarett and Doull's Toxicology: The Basic Science of Poisons. 9th and 8 th Editions, McGraw-Hill, (2018, 2013).

8. Hayes, A.W., Ed.: Principles and Methods of Toxicology. 6th Edition, CRC Press, (2014). 

9. Torres, J. and Bobst, S. (eds.). Toxicological Risk Assessment for Beginners, Springer, (2015). 

10. Gilman, A.G., Rall, T.W., Nies, A.S. and Taylor, P., Eds: Goodman and Gilman's The Pharmacological Basis of Therapeutics, 12th Edition (2011) 

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11. RITA guidelines All three parts are available (Regulatory of Industrial Guidelines), How to take tissue & specimen for histopathology?

12. Nonneoplastic Lesion Atlas Part of the National Toxicology Program Useful website for evaluation of gross pathology. 

13. AVMA Guidelines for the Euthanasia of Animals:2020 Edition ( American Veterinary Medical Association )

14. Manual of Histologic Staining Methods of the Armed forces institute of Pathology,  Author Lee J -Luna (Mother Standard Protocol for H&E Staining).

                                                                    

                                                               END OF DOCUMENTS

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