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- Proposal for criteria to be used in the classification of R48 for haemolytic anaemia in repeated dose toxicity studies.
Final report from the Working Group on Haemolytic Anaemia, based on the comments from Belgium, Denmark, Germany, Industry, Ireland, The Netherlands and The United Kingdom, August 2004
 size: 78 kB
- Evaluation of immunorelevant organs
size: 8 kB
- ICH: Immuntoxicology Summary
Gerd Bode, July 2004
size: 10 kB
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Germolec DR, Nyska A, Kashon M, Kuper CF, Portier C, Kommineni C, Johnson KA, Luster MI (2004) Extended histopathology in immunotoxicity testing: interlaboratory validation studies. Toxicol Sci 78: 107-115
Above link shows the PubMed abstract
- Inquiry regarding immunotox-testing according to CPMP
Distributed via the Immunotoxicology Technical Committee (ILSI)
November 2002
size: 42 kB
- ICH Survey on Immunotoxicity Data for Development of the Harmonized Guideline of Immunotoxicity Study of Pharmaceuticals
ICH, February 2003
 zipped Excel files, size: 154 kB
- Proposal: Development of a Preclinical Immunotoxicity Testing Database
Pfizer, Inc., Tom Kawabata, October 2002
size: 78 kB
- Immunotoxicology evaluations in non human primates: Relevance and hurdles
Aventis, Francois Verdier, March 2002
size: 893 kB
- Immunotoxicity Testing Strategy
Novartis Pharma, Pathology, February 2002
size: 47 kB
Harmonization of immunotoxicity guidelines
- ICH S8 Immunotoxicity studies for human pharmaceuticals
EMEA, October 2005
size: 98 kB, EMEA Web server
- ICH S8 Immunotoxicity studies for human pharmaceuticals
FDA, April 2006
size: 73 kB, FDA Web server
- Ruehl-Fehlert C, Bradley A, George C, Germann PG, Bolliger AP, Schulte A; European Society of Toxicological Pathology (ESTP) (2005) Harmonization of immunotoxicity guidelines in the ICH process – pathology considerations from the guideline Committee of the European Society of Toxicological Pathology (ESTP). Exp Toxic Pathol 57: 1-5
Above link shows the PubMed abstract
- Haley P, Perry R, Ennulat D, Frame S, Johnson C, Lapointe JM, Nyska A, Snyder P, Walker D, Walter G; STP Immunotoxicology Working Group (2005) STP position paper: best practice guideline for the routine pathology evaluation of the immune system. Toxicol Pathol 33: 404-407
Above link goes to PubMed, no abstract available
- van der Laan JW, van Loveren H (2005) Current status and burning issues in immunotoxicity testing of drugs. Toxicol Appl Pharmacol 207: 435-440
Above link shows the PubMed abstract
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