Journal of Bioequivalence & Bioavailability

Lutz Heinemann

Publications

• Research Article
  Differences in Relative Bioavailability (BA) of Inhalation Insulin Determined using Insulin and Glucose Levels Following Subcutaneous and Inhalation Administration in Humans
  Author(s): Chyung S. Cook, Paul W. Valaitis, Andrew Brugger, Tim Heise, Jerry Gass, Laura Anderson, Janice Troeger, Steve White, Uta Eckers, Leszek Nosek, Klause Rave and Lutz HeinemannChyung S. Cook, Paul W. Valaitis, Andrew Brugger, Tim Heise, Jerry Gass, Laura Anderson, Janice Troeger, Steve White, Uta Eckers, Leszek Nosek, Klause Rave and Lutz Heinemann
  
  BA may be determined using both plasma concentrations of a drug (pharmacokinetic parameters) and its pharmacological effects (pharmacodynamic parameters). However, the resulting assessments of BA can be substantially different. In a relative BA study (N=30) 10 IU (0.35 mg) Actrapid ® was administered subcutaneously with comparison to a 6.5 mg dose of recombinant human insulin inhalation powder (RHIIP) administered using the Cyclohaler TM dry powder inhaler under euglycemic glucose clamp conditions. Relative BA following the inhalation administration compared with the subcutaneous dose was 12.0±1.8% and 6.3±0.6% when determined using baseline-adjusted insulin and glucose infusion rate (GIR), respectively. To explain the observed differences in BA, a pharmacokinetic-pharmacodynamic model was developed and BAs were predicted at different doses of inhalation insulin with.. View More»
  DOI: 10.4172/jbb.1000085

  Abstract PDF