GDUFA Research Outcomes

Data Analytics and AI

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to data analytics and artificial intelligence (AI) for generic product development and assessment, including the development of natural language processing (NLP) and machine learning (ML) tools

• All(101)
• Posters(25)
• Presentations(27)
• Papers(49)

• Big Data Application in Life Sciences

  Zhao, Liang

• Regulatory Science Issues in the Effect of Microbimes on Bioequivalence Determination for Generic Drug Products

  Zhang, Lei

• Developing a Statistical Approach to Facilitate Sameness Assessment of Complex Heterogenous Active Pharmaceutical Ingredients

  Weng, Yu Ting; Hu, Meng; Zhao, Liang; Wang, Chao; Shen, Meiyu; Gong, Xiajing

• IVPT Data Challenges and Statistical Analysis

  Ghosh, Priyanka

• Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and Multivariate Statistical Distance (MSD) Method

  Gong, Xiajing

• An Open Access Excipients Database and Its Use to Investigate Their Possible Biological Targets

  Shoichet, B

• Changing Physician and Patient Perceptions about Generic Drugs

  Sarpatwari, Ameet

• Provider-Level Variation And Determinants Of Outpatient Generic Prescribing In A Mixed-Payer Healthcare System

  Romanelli, Robert; Nimbal, Vani; Segal, Jodi

• Use of Data Analytics Approaches to Support Regulatory Assessment – from FDA Perspective

  Hu, Meng

• Leveraging Artificial Intelligence (AI) and Machine Learning (ML) to Support Generic Drug Development and Regulatory Efficiency

  Hu, Meng