Development of the ICH guidelines for immunotoxicology evaluation of pharmaceuticals using a survey of industry practices

Journal of Immunotoxicology

Volumn 2, Issue 3, 2005, Pages 171-180

  Weaver, James L ^a,n   Tsutsui, Naohisa ^b   Hisada, Shigeru ^c   Vidal, Jean Marc ^d   Spanhaak, Steven ^e   Sawada, Jun Ichi ^f   Hastings, Kenneth L ^a   Van Der Laan, Jan Willem ^g   Van Loveren, Henk ^g   Kawabata, Thomas T ^h   Sims, Jennifer ⁱ   Durham, Stephen K ^j   Fueki, Osamu ^k   Matula, Tibor I ^l   Kusunoki, Hirofumi ^m   Ulrich, Peter ^o   Nakamura, Kazuichi ^p  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

^c Grelan Pharmaceutical Co Ltd   (Japan)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^f NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^g NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^h PFIZER INC   (United States)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

^j BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^k PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^l HEALTH CANADA   (Canada)

^m Japan Ministry of Health Labour and Welfare   (Japan)

ⁿ Life Science Building 64 ^*  (United States)

^o Novartis Pharma AG   (Switzerland)

^p SHIONOGI AND CO LTD   (Japan)

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Author keywords

Guidance; Immunosuppression; Pharmaceutical; Regulatory; Testing

Indexed keywords

CONFERENCE PAPER; DOSE RESPONSE; DRUG ACTIVITY; DRUG SCREENING; IMMUNE RESPONSE; IMMUNOMODULATION; IMMUNOSUPPRESSIVE TREATMENT; IMMUNOTOXICITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUESTIONNAIRE;

EID: 28244436994     PISSN: 16602854     EISSN: 1547691X     Source Type: Journal    
DOI: 10.1080/15476910500241339     Document Type: Conference Paper

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