Revised Estimation of New Drug Product Approval Probabilities in Phased Clinical Trials

Revised Estimation of New Drug Product Approval Probabilities in Phased Clinical Trials

Matthew Chukwuma Michael; Oyeka I. C. A

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; Ajibabe Bright

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GJSFR Volume 17 Issue F5

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The objective of our study was to evaluate, in a population of Togolese People Living With HIV(PLWHIV), the agreement between three scores derived from the general population namely the Framingham score, the Systematic Coronary Risk Evaluation (SCORE), the evaluation of the cardiovascular risk (CVR) according to the World Health Organization.

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 or 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.

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Funding

No external funding was declared for this work.

Conflict of Interest

The authors declare no conflict of interest.

Ethical Approval

No ethics committee approval was required for this article type.

Data Availability

Not applicable for this article.

Matthew Chukwuma Michael. 2017. \u201cRevised Estimation of New Drug Product Approval Probabilities in Phased Clinical Trials\u201d. Global Journal of Science Frontier Research - F: Mathematics & Decision GJSFR-F Volume 17 (GJSFR Volume 17 Issue F5): .

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GJSFR Volume 17 Issue F5
Pg. 33- 49

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Journal Specifications

Crossref Journal DOI 10.17406/GJSFR

Print ISSN 0975-5896

e-ISSN 2249-4626

Keywords

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Classification

GJSFR-F Classification: MSC 2010: 97K80

Submission ReceivedJune 17, 2017
RevisedJune 17, 2017
Peer Review Double Blind
Handling Editor
Accepted July 15, 2017
Published July 26, 2017

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v1.2

Issue date

August 24, 2017

Language

English

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Total Score: 102

Country: Nigeria

Subject: Global Journal of Science Frontier Research - F: Mathematics & Decision

Authors: Matthew Chukwuma Michael; Oyeka I. C. A,; Ajibabe Bright (PhD/Dr. count: 0)

View Count (all-time): 178

Total Views (Real + Logic): 3422

Total Downloads (simulated): 1672

Publish Date: 2017 08, Thu

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Total Views: 3422

Total Downloads: 1672

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