L E Black, J D Green, J Rener, A Dayan, J A Cavagnaro, P Spindler, J L Bussiere, P Bouchard, T Inoue, P T Thomas, D M Essayan, N A Gillett, T K Hart, K Hastings, R V House, D Latta, U Liminga, G Treacy, and D Wierda

Safety evaluation of immunomodulatory biopharmaceuticals: can we improve the predictive value of preclinical studies?
Hum Exp Toxicol 2000 19: 205-207. [PDF]  

J D Green and L E Black

Status of preclinical safety assessment for immunomodulatory biopharmaceuticals
Hum Exp Toxicol 2000 19: 208-212. [Abstract] [PDF]  

Summaries of round-table discussions
Hum Exp Toxicol 2000 19: 213-218. [PDF] [References]  

A G Hendrickx, N Makori, and P Peterson

Nonhuman primates: their role in assessing developmental effects of immunomodulatory agents
Hum Exp Toxicol 2000 19: 219-225. [Abstract] [PDF] [References]  

G Treacy

Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFa monoclonal antibody
Hum Exp Toxicol 2000 19: 226-228. [PDF] [References]  

D Latta

Rapamune: a novel macrolide immunosuppressant for transplantation
Hum Exp Toxicol 2000 19: 229. [PDF]  

P J Bugelskil, D J Herzykl, S Rehm, A G Harmsen, E V Gore, D M Williams, B E Maleeff, A M Badger, A Truneh, S R O'Brien, R A Macial, P J Wier, D G Morgan, and T K Hart

Preclinical development of keliximab, a Primatized^TM anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies
Hum Exp Toxicol 2000 19: 230-243. [Abstract] [PDF] [References]  

D Wierda

Can host resistance assays be used to evaluate the immunotoxicity of pharmaceuticals?
Hum Exp Toxicol 2000 19: 244-245. [PDF] [References]  

R V House

An overview of in vitro/ex vivo assays for preclinical evaluation of immunomo dulation
Hum Exp Toxicol 2000 19: 246-250. [PDF] [References]  

N A Gillett and C Chan

Applications of immunohistochemistry in the evaluation of immunosuppressive agents
Hum Exp Toxicol 2000 19: 251-254. [Abstract] [PDF] [References]  

D M Essayan

Clinical trial design for immunomodulatory bololgics
Hum Exp Toxicol 2000 19: 255-256. [PDF] [References]  

U Liminga

Preclinical assessments of European Union marketing authorisation applications for aimmunomodulatory biopharmaceuticals
Hum Exp Toxicol 2000 19: 257-260. [Abstract] [PDF] [References]  

K L Hastings

Assessment of immunosuppressant drug carcinogenicity: standard and alternative animal models
Hum Exp Toxicol 2000 19: 261-265. [Abstract] [PDF] [References]  

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