Journal of Bioequivalence & Bioavailability

Christine V. Reynolds

Publications

• Research Article
  Bioequivalence of a Novel Omalizumab Solution for Injection Compared with the Standard Lyophilized Powder Formulation
  Author(s): Gilles J. Rivière, Ching-Ming Yeh, Christine V. Reynolds, Laurence Brookman and Guenther KaiserGilles J. Rivière, Ching-Ming Yeh, Christine V. Reynolds, Laurence Brookman and Guenther Kaiser
  
  Aim: To determine the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of a novel solution for injection (solution) and the reference lyophilized powder formulation (powder) of omalizumab. Methods: In this open-label, parallel-group study, adult atopic subjects (serum immunoglobulin [Ig] E 30−300 IU/ ml; body weight, 40−90 kg) received a single subcutaneous dose (150 or 300 mg) of solution or powder omalizumab. Serum concentrations of total omalizumab, free and total IgE and safety were determined up to 84 days post dose. Bioequivalence was examined for dose-normalized parameters of omalizumab in serum: maximum concentration (C max ), area under the concentration-time curve up to the last quantifiable concentration (AUC 0-tlast ) and up to infinity (AUC 0-inf ). Bioequivalence was concluded if the 90% confidence interval (CI) of the ratio of solution vs. powder .. View More»
  DOI: 10.4172/jbb.1000075

  Abstract PDF