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Journal of Biopharmaceutical Statistics
|
December 15, 2022
Real world data (RWD) in pediatrics
Tamar Lasky, Aloka Chakravarty
Statistical Methods in Medical Research
|
February 21, 2008
Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues
Aloka Chakravarty, Rajeshwari Sridhara
Therapeutic Advances in Drug Safety
|
August 4, 2025
Artificial intelligence in pharmacovigilance: advancing drug safety monitoring and regulatory integration
Ankit Nagar, Joga Gobburu, Aloka Chakravarty
Therapeutic Innovation & Regulatory Science
|
May 5, 2026
Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia
John H Skerritt, Irene Chan, Aloka Chakravarty
Therapeutic Innovation & Regulatory Science
|
May 12, 2024
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
Rominder Singh, William Wang, Aloka Chakravarty, et al.
Journal of the National Cancer Institute
|
February 2, 2010
Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007
Rajeshwari Sridhara, John R Johnson, Robert Justice, et al.
Therapeutic Innovation & Regulatory Science
|
March 19, 2025
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation
Nicolle M Gatto, Elizabeth M Garry, Melanie Wang, et al.
Annals of Epidemiology
|
July 21, 2023
Improving data capture of race and ethnicity for the Food and Drug Administration Sentinel database: a narrative review
Monica Ter-Minassian, Anna J DiNucci, Issmatu S Barrie, et al.
Biomarkers in Medicine
|
May 26, 2021
Perspectives on statistical strategies for the regulatory biomarker qualification process
Suzanne B Hendrix, Robin Mogg, Sue Jane Wang, et al.
Pharmacoepidemiology and Drug Safety
|
August 5, 2025
Evaluating the Impact of Data Standardization on Real-World Data
Elizabeth M Garry, Aidan Baglivo, Priya Govil, et al.
Page
of 2
Search research articles
Search
Showing results (1-10 of 16) with videos related to
Sort By:
Page
of 2
Journal of Biopharmaceutical Statistics
|
December 15, 2022
Real world data (RWD) in pediatrics
Tamar Lasky, Aloka Chakravarty
Statistical Methods in Medical Research
|
February 21, 2008
Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues
Aloka Chakravarty, Rajeshwari Sridhara
Therapeutic Advances in Drug Safety
|
August 4, 2025
Artificial intelligence in pharmacovigilance: advancing drug safety monitoring and regulatory integration
Ankit Nagar, Joga Gobburu, Aloka Chakravarty
Therapeutic Innovation & Regulatory Science
|
May 5, 2026
Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia
John H Skerritt, Irene Chan, Aloka Chakravarty
Therapeutic Innovation & Regulatory Science
|
May 12, 2024
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
Rominder Singh, William Wang, Aloka Chakravarty, et al.
Journal of the National Cancer Institute
|
February 2, 2010
Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007
Rajeshwari Sridhara, John R Johnson, Robert Justice, et al.
Therapeutic Innovation & Regulatory Science
|
March 19, 2025
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation
Nicolle M Gatto, Elizabeth M Garry, Melanie Wang, et al.
Annals of Epidemiology
|
July 21, 2023
Improving data capture of race and ethnicity for the Food and Drug Administration Sentinel database: a narrative review
Monica Ter-Minassian, Anna J DiNucci, Issmatu S Barrie, et al.
Biomarkers in Medicine
|
May 26, 2021
Perspectives on statistical strategies for the regulatory biomarker qualification process
Suzanne B Hendrix, Robin Mogg, Sue Jane Wang, et al.
Pharmacoepidemiology and Drug Safety
|
August 5, 2025
Evaluating the Impact of Data Standardization on Real-World Data
Elizabeth M Garry, Aidan Baglivo, Priya Govil, et al.
Page
of 2