Abstract

This paper proposes and presents a method for the estimation of approval probabilities of new drug or product. The proposed method assumes that three evaluation communities are used to assess and evaluate the quality of a new drug or product and that the evaluation is done by the committees in three period phased clinical trials of the drug product using matched samples of subjects at each phase. Estimates of absolute and conditional approval probabilities by various combination evaluation committees at each phase of clinical trials are provided. Test statistics are also developed testing desired hypothesis at each of the phased clinical trials. The proposed method is illustrated with some sample data. It is shown in terms of estimated probability that it is more difficult for all three evaluation committees to be in complex agreement to approve or not approve a new drug or product than for fewer evaluation committees to grant approval.

How to Cite
UM, OYEKA ICA, Okeh. Estimation of New Drug Product Approval Probabilities in Phased Clinical Trials. Global Journal of Medical Research, [S.l.], nov. 2016. ISSN 2249-4618. Available at: <https://www.medicalresearchjournal.org/index.php/GJMR/article/view/1210>. Date accessed: 28 nov. 2021.


Organize Conference

We organize seminars /symposium /conferences/workshop/webinar worldwide on innovative topics and fields of Computer Science and research. We also collaborate, partner or sponsor with a view to provide our professional guidance and expertise to conduct in standard way.

Read More

Research Membership

Global Journals Inc., as described in our Corporate Statement, is an educational, research, research publishing, and professional membership organization. Elevation to the ranks of Fellow of the Association of the Research Society in Computer and Member of the Association of the Research Society in Computer is open.

Read More