GDUFA Research Outcomes

BE Methods & Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• ICH M13 Guideline Series

  Zhang, Lei

• Essential Elements of BCS III-Based Biowaiver Request

  Zhang, Yi

• Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

  Tampal, Nilufer

• Regulatory Research on the Effect of Excipients on Drug Absorption

  Zhang, Lei

• Biopharmaceutics Classification System Class 3 Waiver

  Zhang, Yi

• Intestinal Influx Transporters: A Missing Piece in the Puzzle?

  Zhang, Lei

• Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples

  Wu, Fang

• Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS-Based Waiver of In Vivo Bioequivalence Studies

  Wu, Fang

• Totality of Evidence Including PBPK Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II)

  Wu, Fang

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang