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

Matthew Chukwuma Michael

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

Matthew Chukwuma Michael * §

Contact

§ Delta State Polytechnic, Ogwashi-Uku

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

Article Fingerprint

ReserarchID

V1Y28

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

AI TAKEAWAY

Connecting with the Eternal Ground

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 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.

References

12 Cites in Article

Reference Format

K Rising,P Bacchetti,L Bero (2009). Reporting Bias in Drug Trials Submitted to the Food and Drug Administration Review of Publication and Presentation.
Jogarao Gobburu,Lawrence Lesko (2009). Quantitative Disease, Drug, and Trial Models.
S Chow,J Liu (2004). Design and Analysis of Clinical Trials: Concept and Methodologies.
Toby Huff (2003). The Rise of Early Modern Science.
Ilya Lipkovich,David Adams,Craig Mallinckrodt,Doug Faries,David Baron,John Houston (2008). Evaluating dose response from flexible dose clinical trials.
S Pocock (2004). Clinical Trials. A Practical Approach.
V Gebski,E Beller,A Keech (2001). Randomized Trials: Elements of a Good Study.
G Koren,M Boloja,D Long,Y Feldman,N Shear (1998). Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester.
Ann Dally,Thalidomide (1998). Thalidomide: was the tragedy preventable?.
G Koren,A Pastuszak (1990). Prevention of unnecessary pregnancy termination by counselling women on drug, chemical and radiation exposure during the first trimester.
G Koren,A Pastuszak,I Sinya (1998). Drugs in pregnancy.
R Collier (2009). Drug development cost estimates hard to swallow.

Download References

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.

How to Cite This Article

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

More Citation Formats

Select Citation Style:

Download Citation

GJSFR Volume 17 Issue F5

Explore Journals Explore Volume Read This Issue

Journal Specifications

Crossref Journal DOI 10.17406/GJSFR

Print ISSN 0975-5896

e-ISSN 2249-4626

Keywords

Not Found

Classification

GJSFR-F Classification MSC 2010: 97K80

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

Version of record

v1.2

Issue date

August 24, 2017

Language

English

Experiance in AR

Explore published articles in an immersive Augmented Reality environment. Our platform converts research papers into interactive 3D books, allowing readers to view and interact with content using AR and VR compatible devices.

View in VR

Read in 3D

Your published article is automatically converted into a realistic 3D book. Flip through pages and read research papers in a more engaging and interactive format.

View in 3D

Article Matrices

Total Score: 146

Country: Nigeria

Subject: Global Journal of Science Frontier Research

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

View Count (all-time): 310

Total Views (Real + Logic): 1175

Total Downloads (simulated): 69

Publish Date: 2017 07, Wed

Monthly Totals (Real + Logic):

Month 1: 56 views
Month 2: 31 views
Month 3: 26 views
Month 4: 36 views
Month 5: 37 views
Month 6: 40 views
Month 7: 34 views
Month 8: 46 views
Month 9: 52 views
Month 10: 31 views
Month 11: 33 views
Month 12: 23 views
Month 13: 23 views
Month 14: 27 views
Month 15: 20 views
Month 16: 39 views
Month 17: 30 views
Month 18: 37 views
Month 19: 23 views
Month 20: 27 views
Month 21: 21 views
Month 22: 48 views
Month 23: 26 views
Month 24: 26 views
Month 25: 27 views
Month 26: 31 views
Month 27: 15 views
Month 28: 43 views
Month 29: 30 views
Month 30: 27 views
Month 31: 39 views
Month 32: 40 views
Month 33: 19 views
Month 34: 30 views
Month 35: 40 views
Month 36: 28 views
Month 37: 39 views
Month 38: 25 views
Month 39: 46 views
Month 40: 30 views
Month 41: 35 views
Month 42: 39 views
Month 43: 37 views
Month 44: 35 views
Month 45: 32 views
Month 46: 22 views
Month 47: 29 views
Month 48: 29 views
Month 49: 26 views
Month 50: 20 views
Month 51: 21 views
Month 52: 42 views
Month 53: 26 views
Month 54: 19 views
Month 55: 39 views
Month 56: 34 views
Month 57: 14 views
Month 58: 47 views
Month 59: 42 views
Month 60: 34 views
Month 61: 27 views
Month 62: 16 views
Month 63: 26 views
Month 64: 13 views
Month 65: 39 views
Month 66: 34 views
Month 67: 24 views
Month 68: 39 views
Month 69: 25 views
Month 70: 27 views
Month 71: 24 views
Month 72: 27 views
Month 73: 35 views
Month 74: 38 views
Month 75: 21 views
Month 76: 44 views
Month 77: 12 views
Month 78: 26 views
Month 79: 16 views
Month 80: 41 views
Month 81: 25 views
Month 82: 36 views
Month 83: 41 views
Month 84: 21 views
Month 85: 34 views
Month 86: 42 views
Month 87: 34 views
Month 88: 19 views
Month 89: 37 views
Month 90: 34 views
Month 91: 23 views
Month 92: 28 views
Month 93: 37 views
Month 94: 23 views
Month 95: 21 views
Month 96: 49 views
Month 97: 36 views
Month 98: 24 views
Month 99: 31 views
Month 100: 49 views
Month 101: 38 views
Month 102: 79 views
Month 103: 39 views
Month 104: 59 views
Month 105: 40 views
Month 106: 40 views
Month 107: 37 views
Month 108: 37 views
Month 109: 33 views
Month 110: 49 views
Month 111: 23 views

Total Views: 1.2K

Total Downloads: 69

All Trends