The ICH S8 immunotoxicity guidance. Immune function assessment and toxicological pathology: Autonomous or synergistic methods to predict immunotoxicity?

Experimental and Toxicologic Pathology

Volumn 57, Issue 5-6, 2006, Pages 373-376

  Spanhaak, Steven ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Guideline; ICH S8; Immunoglobulins; Immunosuppression; Immunotoxicity; Lymphocyte phenotyping; Regulatory; Survey

Indexed keywords

NEW DRUG;

ARTICLE; DRUG APPROVAL; DRUG EFFECT; DRUG SCREENING; EVALUATION; FUNCTIONAL ASSESSMENT; HISTOPATHOLOGY; HUMAN; IMMUNE DEFICIENCY; IMMUNE FUNCTION TEST; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOTOXICITY; LYMPHOCYTE; PATHOLOGY; PHENOTYPE; PRACTICE GUIDELINE;

EID: 33745144992     PISSN: 09402993     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.etp.2006.03.013     Document Type: Article

References (5)

1. CPMP, 2000. CPMP/SWP/1042/99: note for guidance on repeated dose toxicity, 27 July 2000.
2. ICH, 2005. ICH S8: Immunotoxicology studies for human pharmaceuticals. Step 5 document, 13 October 2005.
3. ICICIS group, 1998. Report of validation study of assessment of direct immunotoxicity in the rat. Toxicology 1998;125:183-201.
4. Schulte A., Althoff J., Ewe S., Richter-Reichhelm H.B., and BGVV Group. Two immunotoxicity ring studies according to OECD TG 407-comparison of data on cyclosporin A and hexachlorobenzene. Regul Toxicol Pharmacol 36 (2002) 12-21
5. Weaver J.L., Tsutsui N., Hisada S., Vidal J.M., Spanhaak S., et al. Development of the ICH guidelines for immunotoxicology evaluation of pharmaceuticals using a survey of industry practices. J Immunotoxicol 2 (2005) 171-181