-
1
-
-
84939594254
-
-
EMEA. European Medicines Agency. Note for guidance on preclinical pharmacological and toxicological testing of vaccines. 1997. http://www.emea.eu.int/pdfs/human/swp/046595en.pdf
-
-
-
-
2
-
-
84939594255
-
-
EMEA. European Medicines Agency. Note for guidance on the pre-clinical evaluation of anticancer medicinal products (CPMP/SWP/997/96), 1999. http://www.emea.eu.int/pdfs/human/swp/099796en.pdf
-
-
-
-
3
-
-
84939594256
-
-
EMEA. European Medicines Agency. Note for guidance on repeated dose toxicity (CPMP/SWP/1042/99), 2000. http://www.emea.eu.int/pdfs/human/swp/104299en.pdf
-
-
-
-
4
-
-
84939594257
-
-
EU. Directive 91/414/EEC concerning the placing of plant protection products on the market. Official J 1991;L230. http://europa.eu.int/eur-lex/en/consleg/pdf/1991/en_1991L0414_do_001.pdf
-
-
-
-
5
-
-
84939594258
-
-
EU. Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. Official J 1998;L123(1). http://ecb.jrc.it/
-
-
-
-
6
-
-
84939594259
-
-
EU. Guidance on submissions for food additive evaluations by the scientific committee on food. 2001. http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf
-
-
-
-
7
-
-
84939594260
-
-
EU. Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption. Consolidated text. CONSLEG: 1989L0107 - 20/11/2003, 2003a. http://europa.eu.int/eur-lex/en/consleg/pdf/1989/en_1989L0107_do_001.pdf
-
-
-
-
8
-
-
84939594261
-
-
EU. REACH (Registration, Evaluation and Authorisation of Chemicals), 2003b. http://ecb.jrc.it/REACH/
-
-
-
-
9
-
-
10044243559
-
The accuracy of extended histopathology to detect immunotoxic chemicals
-
Germolec D., Kashon M., Nyska A., Kuper C., Portier C., Kommineni C., et al. The accuracy of extended histopathology to detect immunotoxic chemicals. Toxicol Sci 82 (2004) 504-514
-
(2004)
Toxicol Sci
, vol.82
, pp. 504-514
-
-
Germolec, D.1
Kashon, M.2
Nyska, A.3
Kuper, C.4
Portier, C.5
Kommineni, C.6
-
10
-
-
0034082523
-
US FDA "Redbook II" immunotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins
-
Hinton D.M. US FDA "Redbook II" immunotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins. Toxicol Pathol 28 (2000) 467-478
-
(2000)
Toxicol Pathol
, vol.28
, pp. 467-478
-
-
Hinton, D.M.1
-
11
-
-
84939594262
-
-
ICH.S6 Preclinical safety evaluation of biotechnology-derived pharmaceuticals, ICH Step 4. 1997. http://www.fda.gov/cder/guidance/1859fnl.pdf or http://www.ich.org./LOB/MEDIA503.pdf
-
-
-
-
12
-
-
84939594263
-
-
ICH. S8 Immunotoxicity studies for human pharmaceuticals, ICH Step 4. 2005. http://www.emea.eu.int/pdfs/human/ich/16723504en.pdf or http://www.fda.gov/cber/gdlns/ichs8immuno.pdf
-
-
-
-
13
-
-
0032489063
-
-
ICICIS. International Collaborative Immunotoxicity Study (ICICIS) Group Investigators. Report of validation study of assessment of direct immunotoxicity in the rat. Toxicology 1998;124:183-201.
-
-
-
-
14
-
-
0034130174
-
Histopathologic approaches to detect changes indicative of immunotoxicity
-
Kuper C.F., Harleman J.H., Richter-Reichhelm H.-B., et al. Histopathologic approaches to detect changes indicative of immunotoxicity. Toxicol Pathol 28 (2000) 454-466
-
(2000)
Toxicol Pathol
, vol.28
, pp. 454-466
-
-
Kuper, C.F.1
Harleman, J.H.2
Richter-Reichhelm, H.-B.3
-
15
-
-
0012730493
-
Immune system
-
Haschek W.M., Rousseaux C.G., and Wallig M.A. (Eds), Boston Academic Press, San Diego, New York
-
Kuper C.F., de Heer E., van Loveren H., et al. Immune system. In: Haschek W.M., Rousseaux C.G., and Wallig M.A. (Eds). Handbook of toxicologic pathology vol. 2 (2002), Boston Academic Press, San Diego, New York 585-647
-
(2002)
Handbook of toxicologic pathology
, vol.2
, pp. 585-647
-
-
Kuper, C.F.1
de Heer, E.2
van Loveren, H.3
-
16
-
-
84939594265
-
-
MHLW. Ministry of Health, Labour and Welfare, Japan Pharmaceutical Manufacturers Association (JPMA). Interim draft guidance for immune toxicity testing. 2001.
-
-
-
-
17
-
-
84939594266
-
-
OECD. Guideline for the testing of chemicals 407: repeated dose 28-day oral toxicity study in rodents. 1995.
-
-
-
-
18
-
-
0344520492
-
Two immunotoxicity ring studies according to OECD TG 407 - Comparison of data on cyclosporin A and hexachlorobenzene
-
Schulte A., Althoff J., Ewe S., et al. Two immunotoxicity ring studies according to OECD TG 407 - Comparison of data on cyclosporin A and hexachlorobenzene. Regul Toxicol Pharmacol 36 (2002) 12-21
-
(2002)
Regul Toxicol Pharmacol
, vol.36
, pp. 12-21
-
-
Schulte, A.1
Althoff, J.2
Ewe, S.3
-
19
-
-
20944442212
-
-
STP Immunotoxicology Working Group, Haley P, Perry P, et al. STP position paper: best practice guideline for the routine pathology evaluation of the immune system. Toxicol Pathol 2005;33:404-7.
-
-
-
-
20
-
-
84939594268
-
-
TGD. Technical Guidance Document in Support of Commission Directive 93/67/EEC on Risk Assessment for New Substances and Commission Regulation (EC) No. 1488/94 on Risk Assessment for Existing Substances. 2003.
-
-
-
-
21
-
-
84939594269
-
-
US-EPA. Environmental Protection Agency. Health effects test guidelines OPPTS 870.7800 Immunotoxicity. 1998. http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Eff ects_Test_Guidelines/Series/870-7800.pdf
-
-
-
-
22
-
-
84939594270
-
-
US-FDA. Division of Antiviral Drugs Center for Drug Evaluation and Research (CDER). Points to consider in the immunotoxicology evaluation of new drugs intended for the treatment of HIV infection and related disorders. 1993.
-
-
-
-
23
-
-
84939594271
-
-
US-FDA. Food and Drug Administration, Center for Devices and Radiological Health (CDRH). Guidance for Industry and FDA Reviewers. 1999. http://www.fda.gov/cdrh/ost/ostggp/immunotox.html
-
-
-
-
24
-
-
84939594272
-
-
US-FDA. Food and Drug Administration, Department of Health and Human Services, Center for Drug Evaluation and Research (CDER). Guidance for industry: immunotoxicology evaluation of investigational new drugs. 2002.
-
-
-
-
25
-
-
84939594273
-
-
US-FDA. Redbook 2000. Toxicological principles for the safety assessment of food ingredients. Office of Food Additive Safety; 2003. http://www.cfsan.fda.gov/~redbook/red-ivb1.html
-
-
-
-
26
-
-
24644496805
-
Current status and burning issues in immunotoxicity testing of drugs
-
Van der Laan J., and van Loveren H. Current status and burning issues in immunotoxicity testing of drugs. Toxicol Appl Pharmacol 207 Suppl. (2005) 435-440
-
(2005)
Toxicol Appl Pharmacol
, vol.207
, Issue.SUPPL
, pp. 435-440
-
-
Van der Laan, J.1
van Loveren, H.2
|