Survey and Recommendations on the Use of P-Values Driving Decisions in Nonclinical Pharmaceutical Applications

Author:

Altan Stan1,Amaratunga Dhammika2,Cabrera Javier3,Garren Jeonifer4,Geys Helena5,Kolassa John3,LeBlond David6,Li Dingzhou7,Liao Jason8,Liu Jia9,Lubomirski Mariusz10,Miro-Quesada Guillermo11,Novick Steven11,Otava Martin12,Peterson John13,Reckermann Katharina14,Schofield Tim15,Tan Charles16,Tatikola Kanaka1,Tekle Fetene5,Thomas Jennifer17,Vukovinsky Kim7

Affiliation:

1. Janssen R&D, Raritan, NJ

2. Princeton Data Analytics, Bridgewater, NJ

3. Rutgers University, New Brunswick, NJ

4. Pfizer Inc, Cambridge, MA

5. Janssen R&D, Beerse, Belgium

6. CMCStats, Wadsworth, Il

7. Pfizer Inc, Groton, CT

8. Incyte Corp, Wilmington, DE

9. Pfizer Inc, Andover, MA

10. Amgen Inc, Thousand Oaks, CA

11. AstraZeneca, Gaithersburg, MD

12. Janssen R&D, Prague, Czechia

13. PDQ Research & Consulting, Birdsboro, PA

14. Roche Diagnostics Gmbh, Penzberg, Germany

15. CMC Sciences LLC, Germantown, MD

16. Pfizer Inc, Collegeville, PA

17. Covance by Labcorp, Huntingdon, UK

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Reference106 articles.

1. Nonclinical Statistics

2. Amaratunga, D. (n.d.), “Practical Matters Regarding p-Values and the Generalizability of Results,” Unpublished Manuscript.

3. Three Recommendations for Improving the Use of p-Values

4. Predictive Inference and Scientific Reproducibility

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1. Medical Statistics in Drug Development and Regulatory Approval;Advances in Bioinformatics and Biomedical Engineering;2024-07-18

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