A research and development effort in developing the optimal formulations for new tablet drugs using design of experiments: part 2 (bioequivalence studies)
by Zhe Li; Byung Rae Cho; Brian J. Melloy
International Journal of Experimental Design and Process Optimisation (IJEDPO), Vol. 3, No. 1, 2012

Abstract: As an extension to the dissolution comparison studies in Part 1, this paper further examines the optimal levels of inactive ingredients of a formulation, when excipient changes occur which require crossover designs be performed to demonstrate bioequivalence between the pre-change and post-change formulations. In this paper, a standard 2 × 2 crossover study, as a special type of experimental design, is integrated into the ordinary framework. In addition to the discrete computational method for assessing bioequivalence that is suggested by the FDA, we further develop a continuous method to calculate critical quality characteristics. Incorporating the Taguchi quality loss concept and regulatory requirements, we propose an enhanced formulation optimisation model by simultaneously considering both the mean and variance of related characteristics. A numerical example is given to verify the effectiveness of our proposed approach. Additionally, the simulated results show that the continuous assessment method produces more desirable optimal formulations than the discrete one.

Online publication date: Wed, 27-Aug-2014

The full text of this article is only available to individual subscribers or to users at subscribing institutions.

 
Existing subscribers:
Go to Inderscience Online Journals to access the Full Text of this article.

Pay per view:
If you are not a subscriber and you just want to read the full contents of this article, buy online access here.

Complimentary Subscribers, Editors or Members of the Editorial Board of the International Journal of Experimental Design and Process Optimisation (IJEDPO):
Login with your Inderscience username and password:

Username:        Password:          Forgotten your password?

Want to subscribe?
A subscription gives you complete access to all articles in the current issue, as well as to all articles in the previous three years (where applicable). See our Orders page to subscribe.

If you still need assistance, please email subs@inderscience.com