GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(127)
• Posters(7)
• Presentations(111)
• Papers(9)

• FDA Responses to Questions on Q1/Q2 Sameness

  Mannion, Melissa

• Requirements and Recommendations Related to Inactive Ingredients

  Mannion, Melissa

• Considerations for IVPT Data and Information Submitted in ANDAs

  Manerikar, Archana

• Specificity and Discriminatory Challenges Leading to Limitation in Accurate Complete Identification and Quantification of Excipients in RLS Deformulation

  Mallick, Babita

• The In Vitro Permeation Test (IVPT): Historical Perspective, Current Context, and Future Directions

  Maibach, Howard

• Considerations for IVRT Data and Information Submitted in ANDAs

  Ma, Tien

• Building Mechanistic IVIVC

  Lukacova, Viera

• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use – Guidance Implementation in Q1/Q2 Assessment

  Li, Xinran

• IVPT Data Challenges in the Real World

  Lehman, Paul

• Diffusion Cell Apparatus: Considerations for Design and Use II

  Lee, Luke