Work

Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development

Year: 2022

Type: article

Source: Statistics in Biopharmaceutical Research

DOI: 10.1080/19466315.2022.2120533

Authors: Mark Levenson, Weili He, Li Chen, Sai Dharmarajan, Rima Izem, Zhaoling Meng, Herbert Pang, Frank Rockhold

Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research, AbbVie (United States), Novartis (Switzerland), Novartis Institutes for BioMedical Research, Roche (United States), Genentech, Duke University, Duke Clinical Research Institute

Language: English

Topic: Advanced Causal Inference Techniques

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W4294811771

FWCI: 1.853

Cites: 42

Cited by: 12

Related to: 10