GDUFA Research Outcomes

Human Subject Safety

Human Subject Safety

• All(3)
• Posters(1)
• Presentations(1)
• Papers(1)

• Pharmacogenetic Approaches to Optimize Bioequivalence Studies in Generic Drug Development

  Bae, Jihyun; Shon, Jihong; Kim, Myong-Jin; Li, Karen

• Updates and Current Landscape for Study Population Selection and Additional Mitigation Strategies in Bioequivalence Studies

  Li, Karen; Nguyen, Duyen

• Current Landscape on the Use of Antiemetics in Pharmacokinetic Bioequivalence Studies for Generic Drug Development

  So, Gerald; Li, Karen; Shon, Jihong; Kim, Myong-Jin; Nguyen, Duyen (Zoe)