The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA / ASA‐BIOP Nonclinical Bayesian Working Group-Reference-Cited by-同舟云学术

The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA / ASA‐BIOP Nonclinical Bayesian Working Group

Published:2020-10-06 Issue:2 Volume:20 Page:245-255
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Faya Paul¹^ORCID,Sondag Perceval²,Novick Steven³,Banton Dwaine⁴,Seaman, Jr John W.⁵,Stamey James D.⁵,Boulanger Bruno⁶

Affiliation:

1. Statistics–Discovery/Development Eli Lilly and Company Indianapolis Indiana USA

2. Center for Mathematical Sciences Merck & Co., Inc Kenilworth New Jersey USA

3. Department of Data Sciences & Quantitative Biology, Discovery Sciences, R&D AstraZeneca Gaithersburg Maryland USA

4. Translational Medicine and Early Development Statistics Janssen Raritan New Jersey USA

5. Department of Statistical Science Baylor University Waco Texas USA

6. PharmaLex Statistical Solutions Mont‐Saint‐Guibert Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2072

Reference82 articles.

1. Bayesian Applications in Pharmaceutical Development

2. Bayesian Methods in Pharmaceutical Research

3. FDA. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials Center for Devices and Radiological Health.2010.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-use-bayesian-statistics-medical-device-clinical-trials. Accessed January 7 2020.

4. FDA. Complex Innovative Trial Design Pilot Program.2018.https://www.fda.gov/drugs/development-resources/complex-innovative-trial-designs-pilot-program. Accessed January 7 2020.

5. FDA. Draft Guidance for Meta‐Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.2018.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/meta-analyses-randomized-controlled-clinical-trials-evaluate-safety-human-drugs-or-biological. Accessed February 3 2020.

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