Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals

scientific article published on 24 July 2018

Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals is …
instance of (P31):
scholarly articleQ13442814

External links are
P356DOI10.1016/J.YRTPH.2018.07.006
P698PubMed publication ID30009863

P50authorChristopher J BowmanQ72989354
P2093author name stringLaRonda L Morford
Joy Cavagnaro
Wendy G Halpern
Diann L Blanset
Meredith Rocca
P2860cites workA comparison of effects on reproduction and neonatal development in cynomolgus monkeys given human soluble IL-4R and mice given murine soluble IL-4R.Q51820841
Selective disruption of lymphotoxin ligands reveals a novel set of mucosal lymph nodes and unique effects on lymph node cellular organization.Q52528591
The preclinical development of Roferon-A.Q53890139
Genetic variation in the RANKL/RANK/OPG signaling pathway is associated with bone turnover and bone mineral density in menQ57322613
Strain-dependent epithelial defects in mice lacking the EGF receptorQ58326927
Compensatory response of IL-1 gene knockout mice after pulmonary infection with Klebsiella pneumoniaeQ62735810
The MHC class I-like IgG receptor controls perinatal IgG transport, IgG homeostasis, and fate of IgG-Fc-coupled drugsQ73149177
Marginal transfer of ReoPro (Abciximab) compared with immunoglobulin G (F105), inulin and water in the perfused human placenta in vitroQ73642484
Evaluation of the reproductive toxicity and embryotoxicity of insulin glargine (LANTUS) in rats and rabbitsQ74260762
Phenotype of a calbindin-D9k gene knockout is compensated for by the induction of other calcium transporter genes in a mouse modelQ80792313
Allelic variations of RANKL/OPG signaling system are related to bone mineral density and in vivo gene expressionQ84943063
Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety DatabaseQ88289186
Placental and Fetal Effects of Onartuzumab, a Met/HGF Signaling Antagonist, When Administered to Pregnant Cynomolgus MonkeysQ89076171
RANK is essential for osteoclast and lymph node developmentQ24598872
The MHC class I-related receptor, FcRn, plays an essential role in the maternofetal transfer of gamma-globulin in humansQ28208533
Targeted disruption of mouse EGF receptor: effect of genetic background on mutant phenotypeQ28509173
A specific requirement for PDGF-C in palate formation and PDGFR-alpha signalingQ28585038
OPGL is a key regulator of osteoclastogenesis, lymphocyte development and lymph-node organogenesisQ28589430
PDGFR-alpha signaling is critical for tooth cusp and palate morphogenesisQ28592140
Immune and inflammatory responses in TNF alpha-deficient mice: a critical requirement for TNF alpha in the formation of primary B cell follicles, follicular dendritic cell networks and germinal centers, and in the maturation of the humoral immune reQ28594116
A strain-independent postnatal neurodegeneration in mice lacking the EGF receptorQ33888193
Amino acid transporters in the human placentaQ34131329
Placental transport of immunoglobulin G.Q35172881
Drug transfer and metabolism by the human placenta.Q35788063
Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targetsQ36158922
PDGFRa mutations in humans with isolated cleft palate.Q36253455
The PD-1-PD-L pathway in immunological toleranceQ36405777
An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodiesQ37559465
The placenta, transfer of immunoglobulins, and safety assessment of biopharmaceuticals in pregnancy.Q37986126
Contemporary uses of erythropoietin in pregnancy: a literature reviewQ38127124
An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 InhibitorsQ38803301
Traversing barriers - How thyroid hormones pass placental, blood-brain and blood-cerebrospinal fluid barriersQ39116461
Expression of functionally active FcRn and the differentiated bidirectional transport of IgG in human placental endothelial cellsQ40826883
Variation in transplacental transfer of tyrosine kinase inhibitors in the human perfused cotyledon modelQ41103420
Reproductive toxicity of denosumab in cynomolgus monkeysQ43568859
Placental transfer of Fc-containing biopharmaceuticals across species, an industry survey analysisQ43583667
Effects of natalizumab, an alpha4 integrin inhibitor, on the development of Hartley guinea pigsQ45166775
Variation in genes involved in the RANKL/RANK/OPG bone remodeling pathway are associated with bone mineral density at different skeletal sites in men.Q45298906
Embryo/fetal development in cynomolgus monkeys exposed to natalizumab, an alpha4 integrin inhibitor.Q46024688
Comparative effects of interferon alpha-2b and pegylated interferon alpha-2b on menstrual cycles and ovarian hormones in cynomolgus monkeysQ46109382
Developmental Immunotoxicology Assessment of Rituximab in Cynomolgus MonkeysQ46176587
Perspective on a Modified Developmental and Reproductive Toxicity Testing Strategy for Cancer ImmunotherapyQ46608363
Epithelial immaturity and multiorgan failure in mice lacking epidermal growth factor receptorQ46766121
Teratogen-mediated inhibition of target tissue response to Shh signalingQ48004971
Regulatory T Cells Orchestrate Similar Immune Evasion of Fetuses and Tumors in Mice.Q48093087
Skeletal malformations in rat offspring. Long-term effect of maternal insulin-induced hypoglycemia during organogenesis.Q50801299
Investigation of maternal and fetal exposure to an IgG2 monoclonal antibody following biweekly intravaginal administration to cynomolgus monkeys throughout pregnancy.Q51138447
P304page(s)69-79
P577publication date2018-07-24
P1433published inRegulatory Toxicology and PharmacologyQ2138805
P1476titleApplying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals
P478volume98

Search more.