Juliane Gust, Rafael Ponce, W. Conrad Liles, Gwenn A. Garden & Cameron J. Turtle. (2020) Cytokines in CAR T Cell–Associated Neurotoxicity. Frontiers in Immunology 11.
Crossref
Sandrine Vessillier, Madeline Fort, Lynn O'Donnell, Heather Hinton, Kimberly Nadwodny, Joseph Piccotti, Peter Rigsby, Karin Staflin, Richard Stebbings, Divya Mekala, Aarron Willingham & Babette Wolf. (2020) Development of the first reference antibody panel for qualification and validation of cytokine release assay platforms – Report of an international collaborative study. Cytokine: X 2:4, pages 100042.
Crossref
Fang Yang & Thomas R. Kosten. (2019) Psychopharmacology: neuroimmune signaling in psychiatric disease-developing vaccines against abused drugs using toll-like receptor agonists. Psychopharmacology 236:10, pages 2899-2907.
Crossref
Alexander Batista-Duharte, Damiana Téllez Martínez & Iracilda Zeppone Carlos. (2018) Efficacy and safety of immunological adjuvants. Where is the cut-off?. Biomedicine & Pharmacotherapy 105, pages 616-624.
Crossref
Danuta J. Herzyk & Helen G. Haggerty. (2018) Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies. The AAPS Journal 20:2.
Crossref
L.I. Loberg & K.A. Archer. 2018. Comprehensive Toxicology. Comprehensive Toxicology
343
360
.
H.G. Haggerty, K.D. Price & J.M. Shenton. 2018. Comprehensive Toxicology. Comprehensive Toxicology
826
851
.
K.B. Meyer-Tamaki. 2017. A Comprehensive Guide to Toxicology in Nonclinical Drug Development. A Comprehensive Guide to Toxicology in Nonclinical Drug Development
617
645
.
Gail Pearse. 2017. Immunopathology in Toxicology and Drug Development. Immunopathology in Toxicology and Drug Development
1
35
.
Kendall S. Frazier, Jeffery A. Engelhardt, Pierluigi Fant, Silvia Guionaud, Scott P. Henry, Michael W. Leach, Calvert Louden, Marshall S. Scicchitano, James L. Weaver & Tanja S. Zabka. (2015) Scientific and Regulatory Policy Committee Points-to-consider Paper*. Toxicologic Pathology 43:7, pages 915-934.
Crossref
Annick J. Cauvin, Christopher Peters & Frank Brennan. 2015. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
379
395
.
Rafael A. Ponce. 2014. Molecular Immunotoxicology. Molecular Immunotoxicology
159
188
.
Alexander Batista-Duharte, Miriam Lastre & Oliver Pérez. (2014) Adyuvantes inmunológicos. Determinantes en el balance eficacia-toxicidad de las vacunas contemporáneas. Enfermedades Infecciosas y Microbiología Clínica 32:2, pages 106-114.
Crossref
H.G. Haggerty, K.D. Price & J.M. Shenton. 2014. Reference Module in Biomedical Sciences. Reference Module in Biomedical Sciences.
Leigh Ann Burns‐Naas & Marc J. Pallardy. 2013. Nonclinical Safety Assessment. Nonclinical Safety Assessment
313
346
.
Pritam Sahota, James Popp, Jerry Hardisty & Chirukandath GopinathThomas Monticello & Jeanine Bussiere. 2013. Toxicologic Pathology. Toxicologic Pathology
25
54
.
Hervé N. Lebrec. (2012) Regulatory Forum Opinion Piece*. Toxicologic Pathology 41:3, pages 548-551.
Crossref
Nancy E. Everds & Jacqueline M. Tarrant. (2013) Unexpected Hematologic Effects of Biotherapeutics in Nonclinical Species and in Humans. Toxicologic Pathology 41:2, pages 280-302.
Crossref
Wendy Halpern & David Hutto. 2013. Haschek and Rousseaux's Handbook of Toxicologic Pathology. Haschek and Rousseaux's Handbook of Toxicologic Pathology
751
782
.
Thomas R. Gelzleichter. 2013. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
185
210
.
Padma Kumar Narayanan, Rafael Ponce & Beth Hinkle. 2013. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
65
95
.
Kathleen B. Meyer-Tamaki. 2013. A Comprehensive Guide to Toxicology in Preclinical Drug Development. A Comprehensive Guide to Toxicology in Preclinical Drug Development
489
516
.
Satish K. Singh, Leslie P. Cousens, David Alvarez & Pramod B. Mahajan. (2012) Determinants of immunogenic response to protein therapeutics. Biologicals 40:5, pages 364-368.
Crossref
D. J. Snodin & A. Suitters. 2011. Stephens' Detection and Evaluation of Adverse Drug Reactions. Stephens' Detection and Evaluation of Adverse Drug Reactions
157
214
.
Alexander Batista-Duharte, Erik B. Lindblad & Ernesto Oviedo-Orta. (2011) Progress in understanding adjuvant immunotoxicity mechanisms. Toxicology Letters 203:2, pages 97-105.
Crossref
Satish Kumar Singh. (2011) Impact of Product-Related Factors on Immunogenicity of Biotherapeutics. Journal of Pharmaceutical Sciences 100:2, pages 354-387.
Crossref
Tomoaki Inoue & Kenji Yasugi. (2011) Safety evaluation of biotechnology-derived pharmaceuticals. Drug Delivery System 26:6, pages 622-627.
Crossref
Jacqueline M. Tarrant. (2010) Blood Cytokines as Biomarkers of In Vivo Toxicity in Preclinical Safety Assessment: Considerations for Their Use. Toxicological Sciences 117:1, pages 4-16.
Crossref
H.G. Haggerty, K.D. Price & J.M. Shenton. 2010. Comprehensive Toxicology. Comprehensive Toxicology
489
519
.
Janet B. Clarke. 2010. Adverse Drug Reactions. Adverse Drug Reactions
453
474
.
Rafael Ponce, Leslie Abad, Lakshmi Amaravadi, Thomas Gelzleichter, Elizabeth Gore, James Green, Shalini Gupta, Danuta Herzyk, Christopher Hurst, Inge A. Ivens, Thomas Kawabata, Curtis Maier, Barbara Mounho, Bonita Rup, Gopi Shankar, Holly Smith, Peter Thomas & Dan Wierda. (2009) Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies. Regulatory Toxicology and Pharmacology 54:2, pages 164-182.
Crossref
Jason D Graci, Joseph M Colacino, Stuart W Peltz, Joseph P Dougherty & Zhengxian Gu. (2009) HIV Type-1 Latency: Targeted Induction of Proviral Reservoirs. Antiviral Chemistry and Chemotherapy 19:5, pages 177-187.
Crossref
PY Muller & FR Brennan. (2009) Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies. Clinical Pharmacology & Therapeutics 85:3, pages 247-258.
Crossref
Claire Watterson, Anne Lanevschi, Judith Horner & Calvert Louden. (2009) A Comparative Analysis of Acute-phase Proteins as Inflammatory Biomarkers in Preclinical Toxicology Studies: Implications for Preclinical to Clinical Translation. Toxicologic Pathology 37:1, pages 28-33.
Crossref
Ian Gourley & Jacques Descotes. 2008. Immunotoxicology Strategies for Pharmaceutical Safety Assessment. Immunotoxicology Strategies for Pharmaceutical Safety Assessment
373
384
.