GDUFA Research Outcomes

Other Generics Resaerch

• All(111)
• Posters(8)
• Presentations(90)
• Papers(13)

• Scientific Harmonization of Bioequivalence Standards for Generic Drugs

  Zhang, Lei

• Harmonization of Bioequivalence FDA Perspective

  Zhang, Lei

• Drug-Drug Interactions and Generic Drugs

  Zhang, Lei

• Role of Regulatory Science in Reducing Barries to Generic Drug Product Development

  Zhang, Lei

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei

• ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs

  Zhang, Lei

• Bioquivalence for Immediate-Release Solid Oral Dosage Forms Category

  Zhang, Lei

• U.S. FDA Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs -Update-

  Zhang, Lei

• Bioequivalence Evaluation For Generic Drug Products -Discussion with PKWP-

  Zhang, Lei

• Complex Generic Drug Products Challenges in Development

  Zhang, Lei