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EQUIVALENCE OF ORALLY INHALED PRODUCTS
Session Chair(s)
Steven Teerenstra, PhD, MSc
Statistician
Medicines Evaluation Board, Netherlands
EQUIVALENCE OF ORALLY INHALED PRODUCTS
Speaker(s)
Proof of Assay Sensitivity in Equivalence/Noninferiority Studies
Dieter Hauschke Hauschke, DrSc
University Medical Center, Germany
Head of Biometry
Establishing PK Equivalence in Orally Inhaled Products with Highly Variable Reference Products
Alfredo Garcia-Arieta, PharmD, MS
Spanish Agency for Medicines and Healthcare Products (AEMPS), Spain
Had of Service on Pharmacokinetics and Generics
Clinical Considerations on Design of Studies to Support Generics Applications for Orally Inhaled Products
Hanneke Van Der Woude
Medicines Evaluation Board, Netherlands
Clinical Assessor
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