Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery

Establishing the Suitability of Model‐Integrated Evidence to Demonstrate Bioequivalence for Long‐Acting Injectable and Implantable Drug Products: Summary of Workshop

(2023) Yuqing Gong et al.   CPT-Pharmacometrics & Systems Pharmacology

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

(2023) Andrew Babiskin et al.   CPT-Pharmacometrics & Systems Pharmacology

Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System

(2022) Satish Sharan et al.   AAPS Journal

Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective

(2022) Bryan Newman et al.   ADVANCED DRUG DELIVERY REVIEWS

Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

(2021) Eleftheria Tsakalozou et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Innovation for Generic Drugs: Science and Research under GDUFA

(2019) Robert A. Lionberger   CLINICAL PHARMACOLOGY & THERAPEUTICS

Generating Model Integrated Evidence for Generic Drug Development and Assessment

(2018) Liang Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS