Generating Model Integrated Evidence for Generic Drug Development and Assessment

Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis

(2018) Xiajing Gong et al.   CTS-Clinical and Translational Science

Investigating the Impact of Drug Crystallinity in Amorphous Tacrolimus Capsules on Pharmacokinetics and Bioequivalence Using Discriminatory In Vitro Dissolution Testing and Physiologically Based Pharmacokinetic Modeling and Simulation

(2018) Hitesh S. Purohit et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

What Factors May Impact the Likelihood of First Abbreviated New Drug Application (ANDA) Submission for a Reference Product?

(2018) S Wittayanukorn et al.   VALUE IN HEALTH

Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

(2016) Edwin Chiu Yuen Chow et al.   AAPS Journal

A Molecular Basis for Innovation in Drug Excipients

(2016) JJ Irwin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically Based Pharmacokinetic Modeling for Substitutability Analysis of Venlafaxine Hydrochloride Extended-Release Formulations Using Different Release Mechanisms: Osmotic Pump Versus Openable Matrix

(2016) Ho-Pi Lin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

(2016) Alex Yu et al.   MOLECULAR PHARMACEUTICS

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

(2015) Wenlei Jiang et al.   AAPS Journal

Modern analytics for synthetically derived complex drug substances: NMR, AFFF–MALS, and MS tests for glatiramer acetate

(2015) Sarah Rogstad et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Absorption and Clearance of Pharmaceutical Aerosols in the Human Nose: Effects of Nasal Spray Suspension Particle Size and Properties

(2015) Alex Rygg et al.   PHARMACEUTICAL RESEARCH

Development and Application of a Mechanistic Pharmacokinetic Model for Simvastatin and its Active Metabolite Simvastatin Acid Using an Integrated Population PBPK Approach

(2014) Nikolaos Tsamandouras et al.   PHARMACEUTICAL RESEARCH

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Population pharmacodynamic modeling of various extended-release formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis

(2012) Holly Kimko et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

(2012) Robert A. Lionberger et al.   PHARMACEUTICAL RESEARCH

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

(2011) Xinyuan Zhang et al.   AAPS Journal

Quantitative clinical pharmacology is transforming drug regulation

(2010) Carl C. Peck   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS