A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution Benjamin WeberGuenther HochhausSau L. Lee Research Article 25 September 2012 Pages: 1 - 9
Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration Bing V. LiBarbara M. DavitDale P. Conner Regulatory Note 28 September 2012 Pages: 10 - 14
Study Reanalysis Using a Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Pramlintide in Subjects with Type 1 Diabetes Jing FangCornelia B. LandersdorferWilliam J. Jusko Research Article 02 October 2012 Pages: 15 - 29
Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics Lei ZhouSarah A. HoofringMarta Starcevic Research Article 09 October 2012 Pages: 30 - 40
Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products Rong-Kun ChangAndre RawLawrence Yu Regulatory Note 09 October 2012 Pages: 41 - 52
Renal Organic Anion Transporters (SLC22 Family): Expression, Regulation, Roles in Toxicity, and Impact on Injury and Disease Li WangDouglas H. Sweet Review Article 09 October 2012 Pages: 53 - 69
Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes Ramak PourvaseiEd LeeBinodh DeSilva Research Article 09 October 2012 Pages: 70 - 77
Interactions of Everolimus and Sorafenib in Pancreatic Cancer Cells Dipti K. PawaskarRobert M. StraubingerWilliam J. Jusko Research Article 09 October 2012 Pages: 78 - 84
Biodegradable Particles as Vaccine Delivery Systems: Size Matters Vijaya B. JoshiSean M. GearyAliasger K. Salem Research Article 10 October 2012 Pages: 85 - 94
Pilot Investigation on Long-Term Subcutaneous Microdialysis: Proof of Principle in Humans Franziska SimmelClaudia KirbsCharlotte Kloft Research Article 13 October 2012 Pages: 95 - 103
How Promiscuous Are Pharmaceutically Relevant Compounds? A Data-Driven Assessment Ye HuJürgen Bajorath Research Article 23 October 2012 Pages: 104 - 111
Determination of the Dominant Arachidonic Acid Cytochrome P450 Monooxygenases in Rat Heart, Lung, Kidney, and Liver: Protein Expression and Metabolite Kinetics Ahmed A. El-SherbeniMona E. AboutablAyman O. S. El-Kadi Research Article 10 November 2012 Pages: 112 - 122
Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling Daniel BurnsLaura BrunnerJin Wang Research Article 08 November 2012 Pages: 123 - 131
Amino-Terminated Generation 2 Poly(amidoamine) Dendrimer as a Potential Broad-Spectrum, Nonresistance-Inducing Antibacterial Agent Xiaoyan XueXiaoqing ChenXiaoxing Luo Research Article 08 November 2012 Pages: 132 - 142
Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data Tycho HeimbachBinfeng XiaHandan He Research Article 10 November 2012 Pages: 143 - 158
A Pharmacokinetic Simulation Tool for Inhaled Corticosteroids Benjamin WeberGuenther Hochhaus Research Article 10 November 2012 Pages: 159 - 171
The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics Juan Jose Perez RuixoPeiming MaAndrew T. Chow Review Article 10 November 2012 Pages: 172 - 182
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-GuillenAlvaro JandaIñaki F. Troconiz Research Article 08 November 2012 Pages: 183 - 194
Therapeutic Roles of Curcumin: Lessons Learned from Clinical Trials Subash C. GuptaSridevi PatchvaBharat B. Aggarwal Review Article 10 November 2012 Pages: 195 - 218
Supersaturated Self-Nanoemulsifying Drug Delivery Systems (Super-SNEDDS) Enhance the Bioavailability of the Poorly Water-Soluble Drug Simvastatin in Dogs Nicky ThomasRené HolmThomas Rades Research Article 21 November 2012 Pages: 219 - 227
Pocket-Based Drug Design: Exploring Pocket Space Xiliang ZhengLinFeng GanJin Wang Review Article 22 November 2012 Pages: 228 - 241
In Vivo Quantification of Active Decitabine-Triphosphate Metabolite: A Novel Pharmacoanalytical Endpoint for Optimization of Hypomethylating Therapy in Acute Myeloid Leukemia Hongyan WangPing ChenGuido Marcucci Research Article 22 November 2012 Pages: 242 - 249
Integrated Pharmacokinetic-Driven Approach to Screen Candidate Anticancer Drugs for Brain Tumor Chemotherapy Hua LvXiaoping ZhangJames M. Gallo Research Article 22 November 2012 Pages: 250 - 257
The Liver X Receptor Agonist T0901317 Protects Mice from High Fat Diet-Induced Obesity and Insulin Resistance Mingming GaoDexi Liu Research Article 22 November 2012 Pages: 258 - 266
A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with the In Vivo Data Uroš KlančarBoštjan MarkunIgor Legen Research Article 28 November 2012 Pages: 267 - 277
Mechanistic Models Describing Active Renal Reabsorption and Secretion: A Simulation-Based Study Melanie A. FelmleeRutwij A. DaveMarilyn E. Morris Research Article 30 November 2012 Pages: 278 - 287
In Vitro and In Vivo Evaluation of a Water-in-Oil Microemulsion System for Enhanced Peptide Intestinal Delivery Dongyun LiuTaku KobayashiRussell J. Mumper Research Article 30 November 2012 Pages: 288 - 298