GDUFA Research Outcomes
QCP Models
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Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment
Zhang, Lei
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Considerations for FEV1-based Comparative Clinical Endpoint or Pharmacodynamic Bioequivalence Studies for Orally Inhaled Drug Products
Gong, Yuqing
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ANDA Challenges Related to Vasoconstrictor Studies
Feng, Kairui
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Acceptability Of Using Alternative Pk Metrics From Systemic Pharmacokinetic (Pk) Data To Inform Regional Deposition For Orally Inhaled Drug Products
Feng, Kairui
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User Friendly Tools for Population PK and PBPK modeling
Bies, Robert S