The AAPS Journal - Volume 15 Number 2, Apr 2013 Articles

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The AAPS Journal

Volume 15 Number 2, Apr 2013

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Coexistence of Passive and Proton Antiporter-Mediated Processes in Nicotine Transport at the Mouse Blood–Brain Barrier
Author(s): Salvatore Cisternino; Hélène Chapy; Pascal André; Maria Smirnova; Marcel Debray; Jean-Michel Scherrmann
External Validation of the Bilirubin–Atazanavir Nomogram for Assessment of Atazanavir Plasma Exposure in HIV-1-Infected Patients
Author(s): Dinko Rekić; Daniel Röshammar; Martin Bergstrand; Joel Tarning; Andrea Calcagno; Antonio D’Avolio; Vidar Ormaasen; Marie Vigan; Aurélie Barrail-Tran; Michael Ashton; Magnus Gisslén; Angela Äbelö
Pharmacokinetics of Levodopa, Carbidopa, and 3-O-Methyldopa Following 16-hour Jejunal Infusion of Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson’s Disease Patients
Author(s): Dag Nyholm; Per Odin; Anders Johansson; Krai Chatamra; Charles Locke; Sandeep Dutta; Ahmed A. Othman
Highly Stabilized Curcumin Nanoparticles Tested in an In Vitro Blood–Brain Barrier Model and in Alzheimer’s Disease Tg2576 Mice
Author(s): Kwok Kin Cheng; Chin Fung Yeung; Shuk Wai Ho; Shing Fung Chow; Albert H. L. Chow; Larry Baum
Simultaneous Analysis of Multiple Monoclonal Antibody Biotherapeutics by LC-MS/MS Method in Rat Plasma Following Cassette-Dosing
Author(s): Hongyan Li; Robert Ortiz; Linh T. B. Tran; Hossein Salimi-Moosavi; Jennifer Malella; Christopher A. James; Jean W. Lee
The Twofold Advantage of the Amorphous Form as an Oral Drug Delivery Practice for Lipophilic Compounds: Increased Apparent Solubility and Drug Flux Through the Intestinal Membrane
Author(s): Arik Dahan; Avital Beig; Viktoriya Ioffe-Dahan; Riad Agbaria; Jonathan M Miller

In Themed Issue: Develop Enabling Technologies for Delivering Poorly Water Soluble Drugs: Current Status and Future Perspectives
Translational Pharmacokinetic-Pharmacodynamic Modeling from Nonclinical to Clinical Development: A Case Study of Anticancer Drug, Crizotinib
Author(s): Shinji Yamazaki

In Themed Issue: Translational Modeling and Dose Selection: From Preclinical to Humans
Controlled Release of Simvastatin from In situ Forming Hydrogel Triggers Bone Formation in MC3T3-E1 Cells
Author(s): Yoon Shin Park; Allan E. David; Kyung Min Park; Chia-Ying Lin; Khoi D. Than; Kyuri Lee; Jun Beom Park; Inho Jo; Ki Dong Park; Victor C. Yang
Dose Selection Based on Physiologically Based Pharmacokinetic (PBPK) Approaches
Author(s): Hannah M. Jones; Kapil Mayawala; Patrick Poulin

In Themed Issue: Translational Modeling and Dose Selection: From Preclinical to Humans
Regulatory Administrative Databases in FDA's Center for Biologics Evaluation and Research: Convergence Toward a Unified Database
Author(s): Jeffrey K. Smith
TargetHunter: An In Silico Target Identification Tool for Predicting Therapeutic Potential of Small Organic Molecules Based on Chemogenomic Database
Author(s): Lirong Wang; Chao Ma; Peter Wipf; Haibin Liu; Weiwei Su; Xiang-Qun Xie

In Themed Issue: New Paradigms in Pharmaceutical Sciences: In Silico Drug Discovery
Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval
Author(s): Jiang Liu; Pravin Jadhav; Yaning Wang; Jogarao Gobburu
In Vivo Quantitative Prediction of the Effect of Gene Polymorphisms and Drug Interactions on Drug Exposure for CYP2C19 Substrates
Author(s): Sylvain Goutelle; Laurent Bourguignon; Nathalie Bleyzac; Johanna Berry; Fannie Clavel-Grabit; Michel Tod
Strategic Applications of Gene Expression: From Drug Discovery/Development to Bedside
Author(s): Jane P. F. Bai; Alexander V. Alekseyenko; Alexander Statnikov; I-Ming Wang; Peggy H. Wong
Animal Models of Osteoarthritis: Challenges of Model Selection and Analysis
Author(s): Erin Teeple; Gregory D. Jay; Khaled A. Elsaid; Braden C. Fleming

In Themed Issue: Human and Veterinary Therapeutics: Interspecies Extrapolations and Shared Challenges
Strategic Biomarkers for Drug Development in Treating Rare Diseases and Diseases in Neonates and Infants
Author(s): Jane P. F. Bai; Jeffrey S. Barrett; Gibert J. Burckart; Bernd Meibohm; Hari Cheryl Sachs; Lynne Yao

In Themed Issue: Challenges and Opportunities in Pediatric Drug Development
A Workflow Example of PBPK Modeling to Support Pediatric Research and Development: Case Study with Lorazepam
Author(s): A. R. Maharaj; J. S. Barrett; A. N. Edginton

In Themed Issue: Challenges and Opportunities in Pediatric Drug Development
A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution
Author(s): Benjamin Weber; Sau L. Lee; Robert Lionberger; Bing V. Li; Yi Tsong; Guenther Hochhaus
The Interaction of Fatty Acid Amide Hydrolase (FAAH) Inhibitors with an Anandamide Carrier Protein Using 19F-NMR
Author(s): Jianqin Zhuang; De-Ping Yang; Spyros P. Nikas; Jianhong Zhao; Jianxin Guo; Alexandros Makriyannis
Drug Discovery and Regulatory Considerations for Improving In Silico and In Vitro Predictions that Use Caco-2 as a Surrogate for Human Intestinal Permeability Measurements
Author(s): Caroline A. Larregieu; Leslie Z. Benet
Simultaneous Pharmacokinetic Model for Rolofylline and both M1-trans and M1-cis Metabolites
Author(s): Mark Stroh; Matthew M. Hutmacher; Jianmei Pang; Ryan Lutz; Hiroshi Magara; Julie Stone
Chemical Imaging of Drug Delivery Systems with Structured Surfaces–a Combined Analytical Approach of Confocal Raman Microscopy and Optical Profilometry
Author(s): Birthe Kann; Maike Windbergs
Effect of Device Design on the Aerosolization of a Carrier-Based Dry Powder Inhaler—a Case Study on Aerolizer® Foradile®
Author(s): Qi Tony Zhou; Zhenbo Tong; Patricia Tang; Mauro Citterio; Runyu Yang; Hak-Kim Chan
Nonaqueous Gel for the Transdermal Delivery of a DTPA Penta-ethyl Ester Prodrug
Author(s): Yong Zhang; Matthew P. Sadgrove; Katsuhiko Sueda; Yu-Tsai Yang; Erik K. Pacyniak; John R. Kagel; Brenda A. Braun; William C. Zamboni; Russell J. Mumper; Michael Jay
Predictions of In Vivo Prolactin Levels from In Vitro Ki Values of D2 Receptor Antagonists Using an Agonist–Antagonist Interaction Model
Author(s): Klas J. Petersson; An M. Vermeulen; Lena E. Friberg
Modeling NSCLC Progression: Recent Advances and Opportunities Available
Author(s): Ahmed Abbas Suleiman; Lucia Nogova; Uwe Fuhr
Modeling, Simulation, and Translation Framework for the Preclinical Development of Monoclonal Antibodies
Author(s): Kenneth T. Luu; Eugenia Kraynov; Bing Kuang; Paolo Vicini; Wei-Zhu Zhong

In Themed Issue: Pharmacokinetic/Pharmadynamic Modeling and Simulation in Drug Discovery and Translational Research
Population-Based Efficacy Modeling of Omalizumab in Patients with Severe Allergic Asthma Inadequately Controlled with Standard Therapy
Author(s): Rui Zhu; Yanan Zheng; Wendy S. Putnam; Jennifer Visich; Mark D. Eisner; John G. Matthews; Karin E. Rosen; David Z. D’Argenio
Influences of Organic Cation Transporter Polymorphisms on the Population Pharmacokinetics of Metformin in Healthy Subjects
Author(s): Hwa Yoon; Hea-Young Cho; Hee-Doo Yoo; Se-Mi Kim; Yong-Bok Lee
Organic Cation Transporter OCTs (SLC22) and MATEs (SLC47) in the Human Kidney
Author(s): Hideyuki Motohashi; Ken-ichi Inui

In Themed Issue: Kidney Transporters: Importance in Clearance, Disease, and Drug-Drug Interactions
Regional-Dependent Intestinal Permeability and BCS Classification: Elucidation of pH-Related Complexity in Rats Using Pseudoephedrine
Author(s): Moran Fairstein; Rotem Swissa; Arik Dahan
The Challenges of Assessing Osteoarthritis and Postoperative Pain in Dogs
Author(s): Michele Sharkey

In Themed Issue: Human and Veterinary Therapeutics: Interspecies Extrapolations and Shared Challenges
In Vitro and In Vivo Evaluation of Amorphous Solid Dispersions Generated by Different Bench-Scale Processes, Using Griseofulvin as a Model Compound
Author(s): Po-Chang Chiang; Yong Cui; Yingqing Ran; Joe Lubach; Kang-Jye Chou; Linda Bao; Wei Jia; Hank La; Jonathan Hau; Amy Sambrone; Ann Qin; Yuzhong Deng; Harvey Wong
Direct and Rapid Genotyping of SLCO1B1 388A>G and 521T>C in Human Blood Specimens Using the SmartAmp-2 Method
Author(s): Kenta Yoshida; Junichi Takano; Yuri Ishizu; Alexander Lezhava; Ichiro Ieiri; Kazuya Maeda; Yoshihide Hayashizaki; Yuichi Sugiyama

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