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.
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USP General Chapter Revision Process
Marques, Margareth
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FDA Responses to Questions on Q1/Q2 Sameness
Mannion, Melissa
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Requirements and Recommendations Related to Inactive Ingredients
Mannion, Melissa
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Considerations for IVPT Data and Information Submitted in ANDAs
Manerikar, Archana
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Specificity and Discriminatory Challenges Leading to Limitation in Accurate Complete Identification and Quantification of Excipients in RLS Deformulation
Mallick, Babita
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The In Vitro Permeation Test (IVPT): Historical Perspective, Current Context, and Future Directions
Maibach, Howard
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Considerations for IVRT Data and Information Submitted in ANDAs
Ma, Tien
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Building Mechanistic IVIVC
Lukacova, Viera
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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
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IVPT Data Challenges in the Real World
Lehman, Paul