The Selection and Control of Starting Materials Should be Governed by Science and Risk-Based Approaches Timothy J. N. WatsonRoger NosalFrank Montgomery Commentary 03 August 2016 Pages: 1 - 3
Statistical Approaches to Assess Biosimilarity from Analytical Data Richard BurdickTodd CoffeyHenriette Kuehne Commentary 05 October 2016 Pages: 4 - 14
Commentary on “Statistical Approaches to Assess Biosimilarity from Analytical Data” by Burdick et al [1] Yi TsongQi XiaYu-Ting Weng Commentary 05 October 2016 Pages: 15 - 17
Nanomaterial Drug Products: Manufacturing and Analytical Perspectives Christie M. SayesGrace V. AquinoAnthony J. Hickey Review Article 07 November 2016 Pages: 18 - 25
Physiologically Based Pharmacokinetic (PBPK) Modeling of Pharmaceutical Nanoparticles Min LiPeng ZouSau Lee Review Article 10 November 2016 Pages: 26 - 42
Bone Regeneration Using Gene-Activated Matrices Sheetal D’MelloKeerthi AtluriAliasger K. Salem Review Article 21 September 2016 Pages: 43 - 53
Bringing Curcumin to the Clinic in Cancer Prevention: a Review of Strategies to Enhance Bioavailability and Efficacy Rama I. MahranMagda M. HagrasDean E. Brenner Review Article 25 October 2016 Pages: 54 - 81
Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform Rong LiuBrian HoffpauirLora Hamuro Protocols in Pharmaceutical Sciences 27 October 2016 Pages: 82 - 91
Early Development Challenges for Drug Products Containing Nanomaterials Jennifer H. GrossmanRachael M. CristJeffrey D. Clogston Research Article 09 September 2016 Pages: 92 - 102
The Effect of Polymorphism on Surface Energetics of D-Mannitol Polymorphs Robert R. SmithUmang V. ShahJerry Y. Y. Heng Research Article 08 September 2016 Pages: 103 - 109
Particle Characterization for a Protein Drug Product Stored in Pre-Filled Syringes Using Micro-Flow Imaging, Archimedes, and Quartz Crystal Microbalance with Dissipation Songyan ZhengAastha PuriMonica Adams Research Article 12 September 2016 Pages: 110 - 116
Role of HLA-DP in the Presentation of Epitopes from the Truncated Bacterial PE38 Immunotoxin Ronit MazorSelamawit AddissieIra Pastan Research Article 27 October 2016 Pages: 117 - 129
Development and Translational Application of an Integrated, Mechanistic Model of Antibody-Drug Conjugate Pharmacokinetics Siddharth SukumaranCrystal ZhangSaroja Ramanujan Research Article 27 September 2016 Pages: 130 - 140
Intra-articular Injection of Urinary Bladder Matrix Reduces Osteoarthritis Development Heather N. JacobsSona RathodJennifer H. Elisseeff Research Article 24 October 2016 Pages: 141 - 149
Development of a Flow-Through USP-4 Apparatus Drug Release Assay to Evaluate Doxorubicin Liposomes Wenmin YuanRui KuaiAnna Schwendeman Research Article 02 August 2016 Pages: 150 - 160
Comparisons of Serum Infliximab and Antibodies-to-Infliximab Tests Used in Inflammatory Bowel Disease Clinical Trials of Remicade® Joseph C. MariniJocelyn SendeckiGopi Shankar Research Article 06 September 2016 Pages: 161 - 171
Application of Item Response Theory to Modeling of Expanded Disability Status Scale in Multiple Sclerosis A. M. NovakovicE. H. J. KrekelsM. O. Karlsson Research Article Open access 15 September 2016 Pages: 172 - 179
Mechanistic Evaluation of Hydration Effects on the Human Epidermal Permeation of Salicylate Esters Shereen YousefYousuf MohammedMichael Roberts Research Article 15 September 2016 Pages: 180 - 190
The Delivery of High-Dose Dry Powder Antibiotics by a Low-Cost Generic Inhaler Thaigarajan ParumasivamSharon S. Y. LeungHak-Kim Chan Research Article 27 September 2016 Pages: 191 - 202
Relation of Transcriptional Factors to the Expression and Activity of Cytochrome P450 and UDP-Glucuronosyltransferases 1A in Human Liver: Co-Expression Network Analysis Shilong ZhongWeichao HanLan Tang Research Article 28 September 2016 Pages: 203 - 214
Pharmacokinetic Dashboard-Recommended Dosing Is Different than Standard of Care Dosing in Infliximab-Treated Pediatric IBD Patients Marla C. DubinskyBecky L. PhanDiane R. Mould Research Article 13 October 2016 Pages: 215 - 222
Magnitude of Increased Infliximab Clearance Imposed by Anti-infliximab Antibodies in Crohn’s Disease Is Determined by Their Concentration Helena EdlundCasper SteenholdtCharlotte Kloft Research Article 13 October 2016 Pages: 223 - 233
Inkjet Printing of Proteins: an Experimental Approach Miguel Montenegro-NicoliniVíctor MirandaJavier O. Morales Research Article 13 October 2016 Pages: 234 - 243
Development of a Non-Aqueous Dispersion to Improve Intestinal Epithelial Flux of Poorly Permeable Macromolecules Sam MaherMekki MedaniDavid J. Brayden Research Article 13 October 2016 Pages: 244 - 253
Specific Immune Response to Phospholipase B-Like 2 Protein, a Host Cell Impurity in Lebrikizumab Clinical Material Saloumeh Kadkhodayan FischerMelissa CheuAn Song Research Article 13 October 2016 Pages: 254 - 263
Further Evaluation of Covariate Analysis using Empirical Bayes Estimates in Population Pharmacokinetics: the Perception of Shrinkage and Likelihood Ratio Test Xu Steven XuMin YuanJose Pinheiro Research Article 19 October 2016 Pages: 264 - 273
Revealing the Neuroendocrine Response After Remoxipride Treatment Using Multi-Biomarker Discovery and Quantifying It by PK/PD Modeling Willem J. van den BrinkYin C. WongElizatbeth C. M. de Lange Research Article Open access 26 October 2016 Pages: 274 - 285
Pharmacokinetic Modeling and Monte Carlo Simulation to Predict Interindividual Variability in Human Exposure to Oseltamivir and Its Active Metabolite, Ro 64-0802 Mototsugu ItoHiroyuki KusuharaYuichi Sugiyama Research Article Open access 31 October 2016 Pages: 286 - 297
Clarithromycin, Midazolam, and Digoxin: Application of PBPK Modeling to Gain New Insights into Drug–Drug Interactions and Co-medication Regimens Daniel MojNina HankeThorsten Lehr Research Article 07 November 2016 Pages: 298 - 312
Mitigation of Pre-existing Antibodies to a Biotherapeutic in Non-clinical Species When Establishing Anti-drug Antibody Assay Cutpoint Seema C KumarJason A DelCarpiniBoris Gorovits Research Article 21 November 2016 Pages: 313 - 319