Scientific and Regulatory Policy Committee Points-to-consider Paper*

Scientific and Regulatory Policy Committee Points-to-consider Paper*

(2015) Kendall S. Frazier et al.   TOXICOLOGIC PATHOLOGY

Preclinical Evaluation of the Toxicological Effects of a Novel Constrained Ethyl Modified Antisense Compound Targeting Signal Transducer and Activator of Transcription 3 in Mice and Cynomolgus Monkeys

(2015) Sebastien A. Burel et al.   Nucleic Acid Therapeutics

Nonclinical Safety Biomarkers of Drug-induced Vascular Injury

(2014) Igor Mikaelian et al.   TOXICOLOGIC PATHOLOGY

Translation Strategy for the Qualification of Drug-induced Vascular Injury Biomarkers

(2014) Kaïdre Bendjama et al.   TOXICOLOGIC PATHOLOGY

Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes

(2014) Jennifer L. Rojko et al.   TOXICOLOGIC PATHOLOGY

Recent insights into C3 glomerulopathy

(2013) Thomas D. Barbour et al.   NEPHROLOGY DIALYSIS TRANSPLANTATION

Species-specific Inflammatory Responses as a Primary Component for the Development of Glomerular Lesions in Mice and Monkeys Following Chronic Administration of a Second-generation Antisense Oligonucleotide

(2013) Kendall S. Frazier et al.   TOXICOLOGIC PATHOLOGY

Regulatory Forum Opinion Piece*

(2012) Michael W. Leach   TOXICOLOGIC PATHOLOGY

International Harmonization of Toxicologic Pathology Nomenclature

(2012) Peter C. Mann et al.   TOXICOLOGIC PATHOLOGY

Histopathology of Incidental Findings in Cynomolgus Monkeys (Macaca Fascicularis) Used in Toxicity Studies

(2012) Junko Sato et al.   Journal of Toxicologic Pathology

Circulating markers of vascular injury and angiogenesis in antineutrophil cytoplasmic antibody-associated vasculitis

(2011) Paul A. Monach et al.   ARTHRITIS AND RHEUMATISM

Potential candidate genomic biomarkers of drug induced vascular injury in the rat

(2011) Deidre A. Dalmas et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Newly identified CpG ODNs, M5-30 and M6-395, stimulate mouse immune cells to secrete TNF-α and enhance Th1-mediated immunity

(2010) Sun-Shim Choi et al.   JOURNAL OF MICROBIOLOGY

Pathways for Cytokine Secretion

(2010) Amanda C. Stanley et al.   PHYSIOLOGY

Spontaneous Findings in the Heart of Mauritian-Origin Cynomolgus Macaques (Macaca fascicularis)

(2010) Justin D. Vidal et al.   TOXICOLOGIC PATHOLOGY

Blood Cytokines as Biomarkers of In Vivo Toxicity in Preclinical Safety Assessment: Considerations for Their Use

(2010) Jacqueline M. Tarrant   TOXICOLOGICAL SCIENCES

Crosstalk pathways between Toll-like receptors and the complement system

(2010) George Hajishengallis et al.   TRENDS IN IMMUNOLOGY

Stimulation of the Immune System by Therapeutic Antisense Oligodeoxynucleotides and Small Interfering RNAs via Nucleic Acid Receptors

(2009) Denise Richardt-Pargmann et al.   Annals of the New York Academy of Sciences

CpG-ODNs induces up-regulated expression of chemokine CCL9 in mouse macrophages and microglia

(2009) C. Ravindran et al.   CELLULAR IMMUNOLOGY

Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies

(2009) Rafael Ponce et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Biomarkers in Peripheral Blood Associated with Vascular Injury in Sprague-Dawley Rats Treated with the Phosphodiesterase IV Inhibitors SCH 351591 or SCH 534385

(2008) James L. Weaver et al.   TOXICOLOGIC PATHOLOGY

Transcriptional Profiling of Laser Capture Microdissected Rat Arterial Elements: Fenoldopam-induced Vascular Toxicity as a Model System

(2008) Deidre A. Dalmas et al.   TOXICOLOGIC PATHOLOGY