Volume 15, Issue 1, January 2013

ISSN: (Print) 1550-7416 (Online)

In this issue (27 articles)

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  1. No Access

    Research Article

    A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution

    Benjamin Weber, Guenther Hochhaus, Wallace Adams, Robert Lionberger… Pages 1-9
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    Regulatory Note

    Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

    Bing V. Li, Barbara M. Davit, Christina H. Lee, Santhosh K. Pabba… Pages 10-14
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    Research Article

    Study Reanalysis Using a Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes

    Jing Fang, Cornelia B. Landersdorfer, Brenda Cirincione… Pages 15-29
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    Research Article

    Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics

    Lei Zhou, Sarah A. Hoofring, Yu Wu, Thuy Vu, Peiming Ma… Pages 30-40
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    Regulatory Note

    Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

    Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu Pages 41-52
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    Review Article

    Renal Organic Anion Transporters (SLC22 Family): Expression, Regulation, Roles in Toxicity, and Impact on Injury and Disease

    Li Wang, Douglas H. Sweet Pages 53-69
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    Research Article

    Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes

    Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel… Pages 70-77
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    Research Article

    Interactions of Everolimus and Sorafenib in Pancreatic Cancer Cells

    Dipti K. Pawaskar, Robert M. Straubinger, Gerald J. Fetterly, Wen W. Ma… Pages 78-84
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    Research Article

    Biodegradable Particles as Vaccine Delivery Systems: Size Matters

    Vijaya B. Joshi, Sean M. Geary, Aliasger K. Salem Pages 85-94
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    Research Article

    Pilot Investigation on Long-Term Subcutaneous Microdialysis: Proof of Principle in Humans

    Franziska Simmel, Claudia Kirbs, Zeynep Erdogan, Edith Lackner… Pages 95-103
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    Research Article

    How Promiscuous Are Pharmaceutically Relevant Compounds? A Data-Driven Assessment

    Ye Hu, Jürgen Bajorath Pages 104-111
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    Research Article

    Determination of the Dominant Arachidonic Acid Cytochrome P450 Monooxygenases in Rat Heart, Lung, Kidney, and Liver: Protein Expression and Metabolite Kinetics

    Ahmed A. El-Sherbeni, Mona E. Aboutabl, Beshay N. M. Zordoky… Pages 112-122
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    Research Article

    Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling

    Daniel Burns, Laura Brunner, Surendran Rajendran, Beth Johnson, Mark Ma… Pages 123-131
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    Research Article

    Amino-Terminated Generation 2 Poly(amidoamine) Dendrimer as a Potential Broad-Spectrum, Nonresistance-Inducing Antibacterial Agent

    Xiaoyan Xue, Xiaoqing Chen, Xinggang Mao, Zheng Hou, Ying Zhou, Hui Bai… Pages 132-142
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    Research Article

    Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data

    Tycho Heimbach, Binfeng Xia, Tsu-han Lin, Handan He Pages 143-158
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    Research Article

    A Pharmacokinetic Simulation Tool for Inhaled Corticosteroids

    Benjamin Weber, Guenther Hochhaus Pages 159-171
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    Review Article

    The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics

    Juan Jose Perez Ruixo, Peiming Ma, Andrew T. Chow Pages 172-182
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    Research Article

    Target-Mediated Disposition Model Describing the Dynamics of IL12 and IFNγ after Administration of a Mifepristone-Inducible Adenoviral Vector for IL-12 Expression in Mice

    Zinnia Patricia Parra-Guillen, Alvaro Janda, Pilar Alzuguren… Pages 183-194
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    Review Article

    Therapeutic Roles of Curcumin: Lessons Learned from Clinical Trials

    Subash C. Gupta, Sridevi Patchva, Bharat B. Aggarwal Pages 195-218
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    Research Article

    Supersaturated Self-Nanoemulsifying Drug Delivery Systems (Super-SNEDDS) Enhance the Bioavailability of the Poorly Water-Soluble Drug Simvastatin in Dogs

    Nicky Thomas, René Holm, Mats Garmer, Jens Jakob Karlsson… Pages 219-227
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