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(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling to Support Regulatory Needs of OIDPs

  Mohamed, Raja

• Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope

  Mohammed, Yousuf

• USP General Chapter Revision Process

  Marques, Margareth

• Requirements and Recommendations Related to Inactive Ingredients

  Mannion, Melissa

• FDA Responses to Questions on Q1/Q2 Sameness

  Mannion, Melissa

• Considerations for IVPT Data and Information Submitted in ANDAs

  Manerikar, Archana

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

  Maibach, Howard

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

  Mallick, Babita

• Considerations for IVRT Data and Information Submitted in ANDAs

  Ma, Tien