Treatment of Inflammatory Bowel Disease with Biologics
257 Denadai R, et al. Induction or exacerbation of psoriatic lesions during anti-TNF-alpha therapy for inflammatory bowel disea ...
258 Xiao X, Chang C. Diagnosis and classification of drug-induced autoimmunity (DIA). J Autoimmun. 2014;48-49:66–72. Costa MF, ...
259 Ramos-Casals M, et al. Autoimmune diseases induced by biological agents: a double-edged sword? Autoimmun Rev. 2010;9(3):188 ...
260 Feltelius N, et al. Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept. Ann ...
© Springer International Publishing AG 2018 261 A.S. Cheifetz, J.D. Feuerstein (eds.), Treatment of Inflammatory Bowel Disease w ...
262 RCT Randomized controlled trial TNF Tumor necrosis factor UC Ulcerative colitis WHO World Health Organization Introduction T ...
263 published in full manuscript form [ 4 , 5 ]. CT-P13 has been marketed as Remsima by Celltrion, Inc., in Europe and other cou ...
264 Scientific Criteria for Demonstration of Biosimilarity Issues in Biosimilar Manufacturing Many of the synthetic and manufact ...
265 whether differences in posttranslational afucosylation may yield to differences in pharmacokinetics and determined that no m ...
266 Clinical Criteria for Demonstration of Biosimilarity Pharmacokinetic Analyses The pharmacokinetic (PK) properties of CT-P13 ...
267 the biosimilar (n = 70), Remicade® from Europe (n = 71) or Remicade® from the USA (n = 70). All three formulations were esse ...
268 CT-P13 in Rheumatoid Arthritis The PLANETRA trial was a phase 3, randomized, double-blind, multicenter, parallel- group stud ...
269 exposure) who received CT-P13 5 mg/kg at weeks 0, 2, and 6, except for three severe UC patients who received either 10 mg/ ...
270 3 mg/kg for RA in conjunction with methotrexate 12.5–25 mg weekly. Of note, RA patients tend to have lower rates of anti-d ...
271 possibility of gaining approval for extrapolation, as well as for interchangeability, is an important motivator for a biotec ...
272 (PK) parameters, using area under the concentration-time curve over the dosing interval (AUCtau) and maximum serum concentra ...
273 Interchangeability In January 2017, the FDA issued theirguidance document regarding the critical issue ofinterchangeability, ...
274 for ABP 501 for adalimumab with the approval in September2016, pending addi- tional studies demonstrating their interchangea ...
275 infliximab or CT-P13 [ 48 , 49 ]. Another infliximabELISAhas been developed that could quantify CT-P13 equally well as with ...
276 and patients [ 56 ]. In the case of infliximab, for example, the proper name in the case of CT-P13 per the FDA naming system ...
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