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Issue Information

Issue Information

  • Pages: i-ii
  • First Published: 12 August 2015

Editorial

Editorial

Ronald T. Borchardt, 
  • Page: 2649
  • First Published: 02 June 2015

COMMENTARY

Gordon L. Amidon: Very Sustained Drug Absorption

Maureen D. Donovan,  James E. Polli,  Peter Langguth,  Ikumi Tamai,  Balvinder Vig,  Lawrence X. Yu, 
  • Pages: 2650-2663
  • First Published: 05 June 2015

Oral Solid Dosage Form Disintegration Testing — The Forgotten Test

Jozef Al-Gousous,  Peter Langguth, 
  • Pages: 2664-2675
  • First Published: 24 December 2014

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam

Marija Petruševska,  Sandra Berglez,  Igor Krisch,  Igor Legen,  Klara Megušar,  Luka Peternel,  Bertil Abrahamsson,  Rodrigo Cristofoletti,  D.W. Groot,  Sabine Kopp,  Peter Langguth,  Mehul Mehta,  James E. Polli,  Vinod P. Shah,  Jennifer Dressman, 
  • Pages: 2676-2687
  • First Published: 06 February 2015

Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product

Steven W. Baertschi,  David Clapham,  Chris Foti,  Mark H. Kleinman,  Solveig Kristensen,  Robert A. Reed,  Allen C. Templeton,  Hanne Hjorth Tønnesen, 
  • Pages: 2688-2701
  • First Published: 24 February 2015

REVIEW

Direct In Vivo Human Intestinal Permeability (Peff) Determined with Different Clinical Perfusion and Intubation Methods

David Dahlgren,  Carl Roos,  Erik Sjögren,  Hans Lennernäs, 
  • Pages: 2702-2726
  • First Published: 19 November 2014

In Vitro Blood–Brain Barrier Models—An Overview of Established Models and New Microfluidic Approaches

Anette Wolff,  Maria Antfolk,  Birger Brodin,  Maria Tenje, 
  • Pages: 2727-2746
  • First Published: 28 January 2015

Animal Farm: Considerations in Animal Gastrointestinal Physiology and Relevance to Drug Delivery in Humans

Grace B. Hatton,  Vipul Yadav,  Abdul W. Basit,  Hamid A. Merchant, 
  • Pages: 2747-2776
  • First Published: 24 February 2015

Rate- and Extent-Limiting Factors of Oral Drug Absorption: Theory and Applications

Kiyohiko Sugano,  Katsuhide Terada, 
  • Pages: 2777-2788
  • First Published: 24 February 2015

Drug Discovery-Development Interface

Multiple Linear Regression Analysis Indicates Association of P-Glycoprotein Substrate or Inhibitor Character with Bitterness Intensity, Measured with a Sensor

Kentaro Yano,  Suzune Mita,  Kaori Morimoto,  Tamami Haraguchi,  Hiroshi Arakawa,  Miyako Yoshida,  Fumiyoshi Yamashita,  Takahiro Uchida,  Takuo Ogihara, 
  • Pages: 2789-2794
  • First Published: 24 December 2014

Prospective Predictions of Human Pharmacokinetics for Eighteen Compounds

Tao Zhang,  Tycho Heimbach,  Wen Lin,  Jin Zhang,  Handan He, 
  • Pages: 2795-2806
  • First Published: 17 February 2015
Free Access

A Sensitive Medium-Throughput Method to Predict Intestinal Absorption in Humans Using Rat Intestinal Tissue Segments

Laís Cristina Da Silva,  Taynara Lourenço Da Silva,  Alisson Henrique Antunes,  Kênnia Rocha Rezende, 
  • Pages: 2807-2812
  • First Published: 17 February 2015
Free Access

Preclinical Pharmacokinetics and In Vitro Metabolism of Asunaprevir (BMS-650032), a Potent Hepatitis C Virus NS3 Protease Inhibitor

Kathleen W. Mosure,  Jay O. Knipe,  Marc Browning,  Vinod Arora,  Yue-Zhong Shu,  Thomas Phillip,  Fiona Mcphee,  Paul Scola,  Anand Balakrishnan,  Matthew G. Soars,  Kenneth Santone,  Michael Sinz, 
  • Pages: 2813-2823
  • First Published: 28 January 2015

Pharmaceutical Biotechnology

Free Access

Selective Oxidation of Methionine and Tryptophan Residues in a Therapeutic IgG1 Molecule

Emilien Folzer,  Katharina Diepold,  Katrin Bomans,  Christof Finkler,  Roland Schmidt,  Patrick Bulau,  JÖRg Huwyler,  Hanns-Christian Mahler,  Atanas V. Koulov, 
  • Pages: 2824-2831
  • First Published: 25 May 2015

Pharmaceutics, Drug Delivery and Pharmaceutical Technology

Free Access

Capric Acid Absorption in the Presence of Hydroxypropyl-β-Cyclodextrin in the Rat Ileum using the In Situ Single-Pass Perfusion Technique

Richard V. Hymas,  Norman F. H. Ho,  William I. Higuchi, 
  • Pages: 2832-2844
  • First Published: 12 November 2014
Free Access

Efficient and High-Speed Transduction of an Antibody into Living Cells Using a Multifunctional Nanocarrier System to Control Intracellular Trafficking

Yuma Yamada,  Sandra Milena Vergara Perez,  Mai Tabata,  Jiro Abe,  Yukari Yasuzaki,  Hideyoshi Harashima, 
  • Pages: 2845-2854
  • First Published: 26 December 2014
Free Access

Investigation of pH and Temperature Profiles in the GI Tract of Fasted Human Subjects Using the Intellicap® System

Mirko Koziolek,  Michael Grimm,  Dieter Becker,  Ventzeslav Iordanov,  Hans Zou,  Jeff Shimizu,  Christoph Wanke,  Grzegorz Garbacz,  Werner Weitschies, 
  • Pages: 2855-2863
  • First Published: 19 November 2014
Free Access

Synthesis and Evaluation of Bile Acid–Ribavirin Conjugates as Prodrugs to Target the Liver

Zhongqi Dong,  Qing Li,  Dong Guo,  Yan Shu,  James E. Polli, 
  • Pages: 2864-2876
  • First Published: 02 February 2015
Free Access

Controlled Release, Intestinal Transport, and Oral Bioavailablity of Paclitaxel Can be Considerably Increased Using Suitably Tailored Pegylated Poly(Anhydride) Nanoparticles

Patricia Calleja,  Socorro Espuelas,  Christine Vauthier,  Gilles Ponchel,  Juan M. Irache, 
  • Pages: 2877-2886
  • First Published: 19 January 2015
Free Access

Evaluation of Acid Tolerance of Drugs Using Rats and Dogs Controlled for Gastric Acid Secretion

Yohei Kosugi,  Syunsuke Yamamoto,  Noriyasu Sano,  Atsutoshi Furuta,  Tomoko Igari,  Yasushi Fujioka,  Nobuyuki Amano, 
  • Pages: 2887-2893
  • First Published: 26 February 2015
Free Access

In Vivo Predictive Dissolution: Comparing the Effect of Bicarbonate and Phosphate Buffer on the Dissolution of Weak Acids and Weak Bases

Brian J. Krieg,  Seyed Mohammad Taghavi,  Gordon L. Amidon,  Gregory E. Amidon, 
  • Pages: 2894-2904
  • First Published: 15 May 2015
Free Access

Influence of Polymer Molecular Weight on Drug–Polymer Solubility: A Comparison between Experimentally Determined Solubility in PVP and Prediction Derived from Solubility in Monomer

Matthias Manne Knopp,  Niels Erik Olesen,  Per Holm,  Peter Langguth,  René Holm,  Thomas Rades, 
  • Pages: 2905-2912
  • First Published: 03 March 2015
Free Access

Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls

Filippos Kesisoglou,  Andre Hermans,  Colleen Neu,  Ka Lai Yee,  John Palcza,  Jessica Miller, 
  • Pages: 2913-2922
  • First Published: 21 January 2015
Free Access

Adsorption of Polyvinylpyrrolidone and its Impact on Maintenance of Aqueous Supersaturation of Indomethacin via Crystal Growth Inhibition

Dhaval D. Patel,  Bradley D. Anderson, 
  • Pages: 2923-2933
  • First Published: 02 June 2015
Free Access

Active Drug Targeting of a Folate-Based Cyclodextrin–Doxorubicin Conjugate and the Cytotoxic Effect on Drug-Resistant Mammary Tumor Cells In Vitro

Hideki Mizusako,  Tatsuaki Tagami,  Kenjiro Hattori,  Tetsuya Ozeki, 
  • Pages: 2934-2940
  • First Published: 04 May 2015
Free Access

Head-To-Head Comparison of Different Solubility-Enabling Formulations of Etoposide and Their Consequent Solubility–Permeability Interplay

Avital Beig,  Jonathan M. Miller,  David Lindley,  Robert A. Carr,  Philip Zocharski,  Riad Agbaria,  Arik Dahan, 
  • Pages: 2941-2947
  • First Published: 18 May 2015
Free Access

An Impedance-Based Method to Determine Reconstitution Time for Freeze-Dried Pharmaceuticals

Tobias Werk,  Joerg Huwyler,  Mathias Hafner,  Joerg Luemkemann,  Hanns-Christian Mahler, 
  • Pages: 2948-2955
  • First Published: 08 April 2015
Free Access

Computational Fluid Dynamics Simulation of Hydrodynamics and Stresses in the PhEur/USP Disintegration Tester Under Fed and Fasted Fluid Characteristics

Sarah Kindgen,  Herbert Wachtel,  Bertil Abrahamsson,  Peter Langguth, 
  • Pages: 2956-2968
  • First Published: 27 May 2015
Free Access

Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine—A Study with Felodipine as a Model Drug

Lennart Lindfors,  Malin Jonsson,  Emelie Weibull,  James G. Brasseur,  Bertil Abrahamsson, 
  • Pages: 2969-2976
  • First Published: 15 May 2015
Free Access

Enhanced Boosting of Oral Absorption of Lopinavir Through Electrospray Coencapsulation with Ritonavir

Shinji Sakuma,  Satoshi Matsumoto,  Narimoto Ishizuka,  Kohta Mohri,  Mayuko Fukushima,  Chie Ohba,  Kohsaku Kawakami, 
  • Pages: 2977-2985
  • First Published: 18 May 2015
Free Access

Two-Stage Single-Compartment Models to Evaluate Dissolution in the Lower Intestine

Constantinos Markopoulos,  Maria Vertzoni,  Mira Symillides,  Filippos Kesisoglou,  Christos Reppas, 
  • Pages: 2986-2997
  • First Published: 18 May 2015
Free Access

Analysis of Diffusion-Controlled Dissolution from Polydisperse Collections of Drug Particles with an Assessed Mathematical Model

Yanxing Wang,  Bertil Abrahamsson,  Lennart Lindfors,  James G. Brasseur, 
  • Pages: 2998-3017
  • First Published: 18 May 2015

Pharmaceutical Nanotechnology

Free Access

In Vitro and In Vivo Performance of Different Sized Spray-Dried Crystalline Itraconazole

Sumit Kumar,  Rajan Jog,  Jie Shen,  Banu Zolnik,  Nakissa Sadrieh,  Diane J. Burgess, 
  • Pages: 3018-3028
  • First Published: 05 September 2014

Pharmacokinetics, Pharmacodynamics and Drug Transport and Metabolism

Free Access

Drug Transporter Protein Quantification of Immortalized Human Lung Cell Lines Derived from Tracheobronchial Epithelial Cells (Calu-3 and BEAS2-B), Bronchiolar–Alveolar Cells (NCI-H292 and NCI-H441), and Alveolar Type II-like Cells (A549) by Liquid Chromatography–Tandem Mass Spectrometry

Atsushi Sakamoto,  Takehisa Matsumaru,  Norio Yamamura,  Shinobu Suzuki,  Yasuo Uchida,  Masanori Tachikawa,  Tetsuya Terasaki, 
  • Pages: 3029-3038
  • First Published: 17 February 2015
Free Access

Quantitative Analysis of the ABCG2 c.421C>A Polymorphism Effect on In Vivo Transport Activity of Breast Cancer Resistance Protein (BCRP) Using an Intestinal Absorption Model

Yuta Tanaka,  Yoshiaki Kitamura,  Kazuya Maeda,  Yuichi Sugiyama, 
  • Pages: 3039-3048
  • First Published: 30 January 2015
Free Access

Kinetics of the Absorption, Distribution, Metabolism, and Excretion of Lobeglitazone, a Novel Activator of Peroxisome Proliferator-Activated Receptor Gamma in Rats

Jong-Hwa Lee,  Chi-Kyoung Noh,  Chang-Soon Yim,  Yoo-Seong Jeong,  Sung Hoon Ahn,  Wooin Lee,  Dae-Duk Kim,  Suk-Jae Chung, 
  • Pages: 3049-3059
  • First Published: 03 February 2015
Free Access

Quantitative Determination of Luminal and Abluminal Membrane Distributions of Transporters in Porcine Brain Capillaries by Plasma Membrane Fractionation and Quantitative Targeted Proteomics

Yoshiyuki Kubo,  Sumio Ohtsuki,  Yasuo Uchida,  Tetsuya Terasaki, 
  • Pages: 3060-3068
  • First Published: 20 February 2015
Free Access

Carrier-Mediated Transport of Nicotine Across the Inner Blood–Retinal Barrier: Involvement of a Novel Organic Cation Transporter Driven by an Outward H+ Gradient

Yuma Tega,  Yoshiyuki Kubo,  Chihiro Yuzurihara,  Shin-Ichi Akanuma,  Ken-Ichi Hosoya, 
  • Pages: 3069-3075
  • First Published: 17 April 2015
Free Access

Design of Fexofenadine Prodrugs Based on Tissue-Specific Esterase Activity and Their Dissimilar Recognition by P-Glycoprotein

Kayoko Ohura,  Yuichiro Nakada,  Shunsuke Kotani,  Teruko Imai, 
  • Pages: 3076-3083
  • First Published: 07 May 2015
Free Access

Effect of Repeated Injections of Adenosine Diphosphate-Encapsulated Liposomes Coated with a Fibrinogen γ-Chain Dodecapeptide Developed as a Synthetic Platelet Substitute on Accelerated Blood Clearance in a Healthy and an Anticancer Drug-Induced Thrombocytopenia Rat Model

Kazuaki Taguchi,  Mai Hashimoto,  Shigeru Ogaki,  Hiroshi Watanabe,  Shinji Takeoka,  Yasuo Ikeda,  Makoto Handa,  Masaki Otagiri,  Toru Maruyama, 
  • Pages: 3084-3091
  • First Published: 09 March 2015
Free Access

Kinetic Evaluation of Determinant Factors for Cellular Accumulation of Protoporphyrin IX Induced by External 5-Aminolevulinic Acid for Photodynamic Cancer Therapy

Takeo Nakanishi,  Tetsuro Ogawa,  Chihiro Yanagihara,  Ikumi Tamai, 
  • Pages: 3092-3100
  • First Published: 08 May 2015

A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment

Hoa Q. Nguyen,  Stephen D. Stamatis,  Lee E. Kirsch, 
  • Pages: 3101-3119
  • First Published: 21 April 2015
Free Access

Impact of Luminal Fluid Volume on the Drug Absorption After Oral Administration: Analysis Based on In Vivo Drug Concentration–Time Profile in the Gastrointestinal Tract

Yusuke Tanaka,  Takanori Goto,  Makoto Kataoka,  Shinji Sakuma,  Shinji Yamashita, 
  • Pages: 3120-3127
  • First Published: 27 March 2015
Free Access

Organic Anion Transporter 4-Mediated Transport of Olmesartan at Basal Plasma Membrane of Human Placental Barrier

Saki Noguchi,  Tomohiro Nishimura,  Ayasa Fujibayashi,  Tetsuo Maruyama,  Masatoshi Tomi,  Emi Nakashima, 
  • Pages: 3128-3135
  • First Published: 26 March 2015
Free Access

In Situ Perfusion Model in Rat Colon for Drug Absorption Studies: Comparison with Small Intestine and Caco-2 Cell Model

Isabel Lozoya-Agullo,  Isabel González-Álvarez,  Marta González-Álvarez,  Matilde Merino-sanjuán,  Marival Bermejo, 
  • Pages: 3136-3145
  • First Published: 17 April 2015
Free Access

Involvement of Concentrative Nucleoside Transporter 1 in Intestinal Absorption of Trifluridine Using Human Small Intestinal Epithelial Cells

Koichi Takahashi,  Kunihiro Yoshisue,  Masato Chiba,  Takeo Nakanishi,  Ikumi Tamai, 
  • Pages: 3146-3153
  • First Published: 21 April 2015
Free Access

An Assessment of the Oral Bioavailability of Three Ca-Channel Blockers Using a Cassette-Microdose Study: A New Strategy for Streamlining Oral Drug Development

Shinji Yamashita,  Makoto Kataoka,  Yuki Suzaki,  Hiromitsu Imai,  Takuya Morimoto,  Kyoichi Ohashi,  Akihiro Inano,  Kazutaka Togashi,  Kuninori Mutaguchi,  Yuichi Sugiyama, 
  • Pages: 3154-3161
  • First Published: 02 June 2015
Free Access

Saturable Hepatic Extraction of Gemcitabine Involves Biphasic Uptake Mediated by Nucleoside Transporters Equilibrative Nucleoside Transporter 1 and 2

Takuya Shimada,  Takeo Nakanishi,  Hidehiro Tajima,  Maiko Yamazaki,  Rina Yokono,  Makiko Takabayashi,  Tsutomu Shimada,  Kazuki Sawamoto,  Ken-Ichi Miyamoto,  Hirohisa Kitagawa,  Tetsuo Ohta,  Ikumi Tamai,  Yoshimichi Sai, 
  • Pages: 3162-3169
  • First Published: 02 June 2015
Free Access

Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation

Andrew H. Babiskin,  Xinyuan Zhang, 
  • Pages: 3170-3182
  • First Published: 13 May 2015
Free Access

Use of a Physiologically Based Pharmacokinetic Model for Quantitative Prediction of Drug–Drug Interactions via CYP3A4 and Estimation of the Intestinal Availability of CYP3A4 Substrates

Yoko Mano,  Yuichi Sugiyama,  Kiyomi Ito, 
  • Pages: 3183-3193
  • First Published: 04 June 2015
Free Access

Prediction of Pharmacokinetics and Pharmacodynamics of Doripenem in Pediatric Patients

Yumiko Matsuo,  Toru Ishibashi,  Kenji Shimamura,  Toshihiro Wajima, 
  • Pages: 3194-3198
  • First Published: 26 March 2015
Free Access

The Influence of Single-Dose and Short-Term Administration of Quercetin on the Pharmacokinetics of Midazolam in Humans

Mai Anh Nguyen,  Petra Staubach,  Siegfried Wolffram,  Peter Langguth, 
  • Pages: 3199-3207
  • First Published: 18 May 2015
Free Access

Zanamivir Amidoxime- and N-Hydroxyguanidine-Based Prodrug Approaches to Tackle Poor Oral Bioavailability

Dennis Schade,  Jürke Kotthaus,  Lukas Riebling,  Joscha Kotthaus,  Helge Müller-Fielitz,  Walter Raasch,  Anja Hoffmann,  Michaela Schmidtke,  Bernd Clement, 
  • Pages: 3208-3219
  • First Published: 02 June 2015
Free Access

The Use of Transporter Probe Drug Cocktails for the Assessment of Transporter-Based Drug–Drug Interactions in a Clinical Setting—Proposal of a Four Component Transporter Cocktail

Thomas Ebner,  Naoki Ishiguro,  Mitchell E. Taub, 
  • Pages: 3220-3228
  • First Published: 15 May 2015
Free Access

Few Drugs Display Flip-Flop Pharmacokinetics and These Are Primarily Associated with Classes 3 and 4 of the BDDCS

Kimberly L. Garrison,  Selma Sahin,  Leslie Z. Benet, 
  • Pages: 3229-3235
  • First Published: 25 May 2015