GDUFA Research Outcomes

Data & 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(125)
• Posters(29)
• Presentations(37)
• Papers(59)

• 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

• Performance of Machine Learning Algorithms for Model Selection

  Sale, Mark

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

  Romanelli, Robert; Nimbal, Vani; Segal, Jodi

• Activity Of Inactive Ingredients: Foundations For Innovation In Drug Excipients

  Pottel, Josh; Algaa, Enkhjargal; Irwin, John; Shoichet, Brian

• Machine Learning For Adverse Drug Event Detection

  Page, David

• Complex Drug Product Landscape

  Jiang, Wenlei

• Post-marketing Surveillance of Generic Drug Usage and Substitution Patterns

  Jiang, Wenlei

• Challenges in Processing PK Data from ANDA Submissions for BE Assessment and Current Perspectives on Updating the PK Data Standard

  Hu, Meng

• Dose Scale Analysis to Support Bioequivalence Assessment

  Hu, Meng