The AAPS Journal: Facilitating Oral Product Development and Reducing Regulatory Burden through Novel Approaches to Assess Bioavailability/Bioequivalence

The AAPS Journal

Facilitating Oral Product Development and Reducing Regulatory Burden through Novel Approaches to Assess Bioavailability/Bioequivalence

Guest Editor(s): James Polli, Jack Cook, Barbara Davit, and Paul Dickinson Status: Closed

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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration
Author(s): Barbara M. Davit; Mei-Ling Chen; Dale P. Conner; Sam H. Haidar; Stephanie Kim; Christina H. Lee; Robert A. Lionberger; Fairouz T. Makhlouf; Patrick E. Nwakama; Devvrat T. Patel; Donald J. Schuirmann; Lawrence X. Yu
Effective Absorption Modeling in Relative Bioavailability Study Risk Assessment
Author(s): John P. Rose
Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations
Author(s): Ethan M. Stier; Barbara M. Davit; Parthapratim Chandaroy; Mei-Ling Chen; Jeanne Fourie-Zirkelbach; Andre Jackson; Stephanie Kim; Robert Lionberger; Mehul Mehta; Ramana S. Uppoor; Yaning Wang; Lawrence Yu; Dale P. Conner
Metrics for the Evaluation of Bioequivalence of Modified-Release Formulations
Author(s): Laszlo Endrenyi; Laszlo Tothfalusi
The Use of Modeling Tools to Drive Efficient Oral Product Design
Author(s): Neil R. Mathias; John Crison
Biopharmaceutic Planning in Pediatric Drug Development
Author(s): Vivek S. Purohit
In vitro–In Vivo Correlations: Tricks and Traps
Author(s): J.-M. Cardot; B. M. Davit
A Technique to Estimate In Vivo Dissolution Profiles Without Data from a Solution
Author(s): Jack A. Cook
An Investigation into the Utility of a Multi-compartmental, Dynamic, System of the Upper Gastrointestinal Tract to Support Formulation Development and Establish Bioequivalence of Poorly Soluble Drugs
Author(s): Paul A. Dickinson; Ragheb Abu Rmaileh; Lee Ashworth; Richard A. Barker; Wendy M. Burke; Claire M. Patterson; Nick Stainforth; Mohammed Yasin
Challenges and Opportunities in Achieving Bioequivalence for Fixed-Dose Combination Products
Author(s): Amitava Mitra; Yunhui Wu
Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence
Author(s): James E. Polli; Jack A. Cook; Barbara M. Davit; Paul A. Dickinson; Domenick Argenti; Nancy Barbour; Alfredo García-Arieta; Jean-Marie Geoffroy; Kerry Hartauer; Shoufeng Li; Amitava Mitra; Francis X. Muller; Vivek Purohit; Manuel Sanchez-Felix; John W. Skoug; Kin Tang
Re-introduction of a Novel Approach to the Use of Stable Isotopes in Pharmacokinetic Studies
Author(s): Alan Parr; Manish Gupta; Timothy H Montague; Frank Hoke
Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA
Author(s): Anil K. Nair; Om Anand; Nam Chun; Dale P. Conner; Mehul U. Mehta; Duong T. Nhu; James E. Polli; Lawrence X. Yu; Barbara M. Davit
Bioequivalence Requirements in the European Union: Critical Discussion
Author(s): Alfredo García-Arieta; John Gordon

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