Developmental Toxicity Testing of Biopharmaceuticals in Nonhuman Primates

Development in the cynomolgus macaque following administration of ustekinumab, a human anti-il-12/23p40 monoclonal antibody, during pregnancy and lactation

(2010) Pauline L. Martin et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Embryo-fetal developmental toxicity of figitumumab, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in cynomolgus monkeys

(2010) Christopher J. Bowman et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

The future of non-human primate use in mAb development

(2010) Kathryn L. Chapman et al.   DRUG DISCOVERY TODAY

Preclinical development of monoclonal antibodies

(2010) Kathryn Chapman et al.   mAbs

Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant's serum

(2009) A Murashima et al.   ANNALS OF THE RHEUMATIC DISEASES

Pre- and postnatal developmental toxicity study design for pharmaceuticals

(2009) Graham P. Bailey et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals

(2009) Pauline L. Martin et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Embryo/fetal development in cynomolgus monkeys exposed to natalizumab, an α4 integrin inhibitor

(2009) Nancy G. Wehner et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Embryo-fetal developmental toxicity study design for pharmaceuticals

(2009) L. David Wise et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Developmental and reproductive toxicology studies in nonhuman primates

(2009) Gary J. Chellman et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Postnatal development in cynomolgus monkeys following prenatal exposure to natalizumab, an α4 integrin inhibitor

(2009) Nancy G. Wehner et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

An interspecies comparison of placental antibody transfer: New insights into developmental toxicity testing of monoclonal antibodies

(2009) Nele Pentšuk et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Absence of Infliximab in Infants and Breast Milk From Nursing Mothers Receiving Therapy for Crohnʼs Disease Before and After Delivery

(2009) Sunanda Kane et al.   JOURNAL OF CLINICAL GASTROENTEROLOGY

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

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

Developmental toxicity testing of monoclonal antibodies: An enhanced pre- and postnatal study design option

(2009) Jane Stewart   REPRODUCTIVE TOXICOLOGY

Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator

(2009) Diana J. Auyeung-Kim et al.   REPRODUCTIVE TOXICOLOGY

Summary Comparison of Female Reproductive System in Human and the Cynomolgus Monkey (Macaca fascicularis)

(2009) Eric Van Esch et al.   TOXICOLOGIC PATHOLOGY

Rituximab Administration in Third Trimester of Pregnancy Suppresses Neonatal B-Cell Development

(2008) D. T. Klink et al.   Clinical & Developmental Immunology

Kisspeptin and the regulation of the hypothalamic–pituitary–gonadal axis in the rhesus monkey (Macaca mulatta)

(2008) Tony M. Plant et al.   PEPTIDES

Is infliximab safe to use while breastfeeding?

(2008) Joel Z Stengel et al.   WORLD JOURNAL OF GASTROENTEROLOGY