| Research Article |
Open Access |
|
| Evaluation of Performance of the Truncated Area Under
Curve (AUC) as a Primary Pharmacokinetic Parameter in
Bioequivalence Studies |
| Suhas Sahebrao Khandave*, Shahoo Vasant Onkar, Satish Vitthal Sawant and Santosh Shrikrishna Joshi |
| Accutest Research Laboratories Limited, A-31, TTC Industrial Area, Khairne MIDC, Navi Mumbai- 400709, Maharashtra, India |
| *Corresponding author: |
Dr. Suhas Sahebrao Khandave
Accutest Research
Laboratories Limited
A-31, TTC Industrial Area, Khairne MIDC
Navi Mumbai-
400709, Maharashtra, India
Tel: 91-22-27780718/19/20
Fax: 91-22-27780721
E-mail: suhas.khandave@accutestindia.com |
|
| |
| Received April 23, 2010; Accepted August 23, 2010; Published August 23, 2010 |
| |
| Citation: Khandave SS, Onkar SV, Sawant SV and Joshi SS (2010) Evaluation
of Performance of the Truncated Area Under Curve (AUC) as a Primary
Pharmacokinetic Parameter in Bioequivalence Studies. J Bioequiv Availab 2: 077-
080. doi:10.4172/jbb.1000035 |
| |
| Copyright: © 2010 Khandave SS, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited. |
| |
| Abstract |
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-lives post dose) were compared individually with those of the total AUC.
The intra-subject variability obtained for partial AUC at 72hrs and 2 half-lives post dose was compared individually for
percentage change from that of the total AUC. |
Results: No change in the study outcome irrespective of the point of truncation of AUC was observed. The 90%
confi dence intervals constructed for the ratio of means of log-transformed partial AUC (at 72hrs and 2 half-lives post
dose) were well within the acceptable bioequivalence criteria of 0.8-1.25. The intra-subject variability for AUC was not
infl uenced irrespective of the point of truncation of AUC. |
Conclusion: Limiting the pharmacokinetic sample collection period to 72 hours in bioequivalence studies for the
drugs having long elimination half-lives is equally accurate and sensitive alternative to the conventional approach. |
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