Journal of Bioequivalence & Bioavailability

Ferrin Harrison

Publications

• Research Article
  Bioequivalence of Long Half-Life Drugs - Informative Sampling Determination -Parallel Designed Studies
  Author(s): Ahmed El-Tahtawy, Ferrin Harrison, Jeanne Fourie Zirkelbach and Andre J. JacksonAhmed El-Tahtawy, Ferrin Harrison, Jeanne Fourie Zirkelbach and Andre J. Jackson
  
  Objective: To determine if 72 hours is the most informative sampling duration for the bioequivalence (BE) determination for drugs with half-lives > 30 h when using a parallel study design. Methods: Two-treatment parallel-designed BE studies were simulated. A one-compartment oral absorption model with half-lives of 30 h and 350 h (clearance = 0.224 or 0.019 L/h), distribution volume = 9.7 L, and inter-subject variability for clearance of 75-250% was simulated. The test/reference ratio for fraction available was investigated at 1.0 and 1.25, while the rate constants for absorption (Ka) were simulated at a test/reference ratio of 1 and 4. AUC values truncated at 12-360 h were calculated. Experimental parallel BE studies drugs were also investigated. Key findings: Experimental BE data indicated a decrease and then an increase in the root mean square error (RMSE) or variability as a.. View More»
  DOI: 10.4172/jbb.1000059

  Abstract PDF