Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

(2011) Xinyuan Zhang et al.   AAPS Journal

The Need for Additional Metrics to Assess Therapeutic Equivalence of Some Multiphasic Modified-Release Products

(2011) Peter M. Kondra et al.   CLINICAL THERAPEUTICS

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report

(2010) Mei-Ling Chen et al.   CLINICAL THERAPEUTICS

Mechanistic Approaches to Predicting Oral Drug Absorption

(2009) Weili Huang et al.   AAPS Journal

Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

(2009) Barbara M Davit et al.   ANNALS OF PHARMACOTHERAPY

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

(2008) Barbara M. Davit et al.   AAPS Journal

Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

(2008) Sam H. Haidar et al.   AAPS Journal