Multi-dose NDD Food effect NA PK in special Target population § populations Single dose NND Multi-dose C0524T14 PK/PD of 100 mg SC and 2 mg/kg IV golimumab in patients with RA Hepatic impairment NND Renal impairment NND NND Elderly NND Other NND Genetic/ Males versus females NND gender- related PK Other NND PK NND interactions Population Healthy subjects NND PK analyses Target population C0524T05 Trough PK for golimumab 50 mg C0524T06 and 100 mg in C0524T09 Phase 3 studies through week 104 C0524T08 C0524T11 Other NND NND: No new data were provided by the sponsor None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Summary of pharmacokinetics The information in the following summary is derived from conventional pharmacokinetic studies unless otherwise stated. NND
Multi-dose NDD Food effect NA PK in special populations Target population § Single dose Multi-dose NND C0524T14 PK/PD of 100 mg SC and 2 mg/kg IV golimumab in patients with RA Hepatic impairment NND Renal impairment NND NND Elderly NND Other NND Genetic/ PK Males versus females NND Other NND PK interactions NND Population PK analyses Healthy subjects NND Target population C0524T05 C0524T06 C0524T09 C0524T08 C0524T11 Trough PK for golimumab 50 mg and 100 mg in Phase 3 studies through week 104 Other NND NND: No new data were provided by the sponsor None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Summary of pharmacokinetics The information in the following summary is derived from conventional pharmacokinetic studies unless otherwise stated. NND gender- related
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