Journal of Bioequivalence & Bioavailability

Suhas Sahebrao Khandave

Publications

• Research Article
  Evaluation of Performance of the Truncated Area Under Curve (AUC) as a Primary Pharmacokinetic Parameter in Bioequivalence Studies
  
  Author(s): Suhas Sahebrao Khandave, Shahoo Vasant Onkar, Satish Vitthal Sawant and Santosh Shrikrishna JoshiSuhas Sahebrao Khandave, Shahoo Vasant Onkar, Satish Vitthal Sawant and Santosh Shrikrishna Joshi
  
  Background and Objective: Prolonged pharmacokinetic sampling is a challenge for successful conduction of the bioequivalence studies for drugs having long elimination half-lives. The regulatory authorities have recommended an alternative to consider the partial AUC (AUC0-72) for studying bioequivalence. However, the results obtained from such truncated approach are not consistent and needs further exploration. We have investigated the suitability of truncated AUC in the fi eld of bioequivalence. Methods: The bioequivalence studies conducted with conventional approach for Bicalutamide, Topiramate and Amitriptyline having long elimination half-lives were investigated. The pharmacokinetic data obtained from these studies was truncated at 72hrs and 2 half-lives post dose. The 90% confi dence intervals constructed for the ratios of means of log-transformed partial AUC (at 72hrs and 2 half.. View More»
  DOI: 10.4172/jbb.1000035

  Abstract