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Redbook

Redbook

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Gửi Thắng.

Thuận
Gửi Thắng.

Thuận

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Published by: Đỗ Lê Đức Thuận on Mar 29, 2014
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 July 2000; Revised July 2007
 Additional copies are available from: Office of Food Additive Safety, HFS-200 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 (Tel)301-436-1200 http://www.cfsan.fda.gov/guidance.html 
 
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied NutritionJuly 2000; Updated July 2007
Note to reader: Individual chapters/sections of this internet version of "Redbook" are available as linked documents via the Table of Contents. The date of revision for each chapter and /or chapter section is provided in the Table of Contents and the individual documents. These revisions supersede previous versions of Redbook A.Introduction
4
 (November 2003) B.General Recommendations for Toxicity Studies
Redbook 2000Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients
Redbook 2000
Table of Contents
1
II. Agency Review of Toxicology Information Submitted in Support of the Safety Assessment of Food Ingredients
(available in 1993 Draft "Redbook II"
2
3
IV. Guidelines for Toxicity Studies
Food
Home > Food > Guidance, Compliance & Regulatory Information > Guidance Documents 
 
Redbook 2000Page 1of 43/3/2010
000001
 
1.General Guidelines for Designing and Conducting Toxicity Studies
5
 (November 2003) 2.Guidelines for Reporting Results of Toxicity Studies
6
 (November 2003) 3.Pathology Considerations in Toxicity Studies
7
 (July 2000) 4.Statistical Considerations in Toxicity Studies
8
 (July 2000) 5.Diets for Toxicity Studies
(available in 1993 Draft "Redbook II"
9
)
 C.Guidelines for Specific Toxicity Studies 1.Short-Term Tests for Genetic Toxicity
10
 (July 2000)
a.Bacterial Reverse Mutation Test
11
 (July 2000) b.
In vitro
 Mammalian Chromosomal Aberration Test
12
 (November 2003) c.
In vitro
 Mouse Lymphoma TK
13
 
+/-
 Gene Mutation Assay
14
 (April 2006) d.
In vivo
Mammalian Erythrocyte Micronucleus Test
15
 (July 2000)
2.Acute Oral Toxicity Tests
(available in 1993 Draft "Redbook II"
16
)
 3.Short Term Toxicity Studies a.Short-Term Toxicity Studies with Rodents
17
 (November 2003) b.Short-Term Toxicity Studies with Non-Rodents
18
 (November 2003) 4.Subchronic Toxicity Studies a.Subchronic Toxicity Studies with Rodents
19
 (November 2003) b.Subchronic Toxicity Studies with Non-Rodents
20
 (November 2003) 5.Chronic Toxicity Studies a.Chronic Toxicity Studies with Rodents
21
 (July 2007) b.One-Year Toxicity Studies with Non-Rodents
22
 (November 2003) 6.Carcinogenicity Studies with Rodents
23
 (January 2006) 7.Combined Chronic Toxicity/Carcinogenicity Studies with Rodents
24
 (July 2007) 8.
In Utero
 Exposure Phase for Addition to Carcinogenicity Studies with Rodents
25
 (July 2007) 9.Reproduction and Developmental Toxicity Studies a.Guidelines for Reproduction Studies
26
 (July 2000) b.Guidelines for Developmental Toxicity Studies
27
 (July 2000) 10.Neurotoxicity Studies
28
 (July 2000) A.Introduction B.Metabolism and Pharmacokinetic Studies C.Immunotoxicity Studies
V. Additional Studies
available in 1993 Draft "Redbook II"
29
VI. Human Studies
Redbook 2000Page 2of 43/3/2010
000002
 
1.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078044.htm 2.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078717.htm 3.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078310.htm 4.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078311.htm 5.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078315.htm 6.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078409.htm 7.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078318.htm 8.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078320.htm 9.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078717.htm 10.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078321.htm 11.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078330.htm 12.http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078332.htm A.Clinical Evaluation of Food Ingredients
(available in 1993 Draft "Redbook II"
30
)
 B.Epidemiology Studies
31
 (October 2001)
1
This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
2
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food 
 (also known as Redbook I), U.S. Food and Drug Administration, Bureau of Foods (now CFSAN), 1982. May be purchased from: National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield, VA 22161, Telephone (703) 605-6000, NTIS Order Number PB83-170696.
3
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food 
 1993 Draft "Redbook II" Table of Contents
33
 
32
Links on this page:
Redbook 2000Page 3of 43/3/2010
000003

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