Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis Anurag S. RathoreMili PathakGaurav Pratap Singh Jadaun Commentary 04 April 2016 Pages: 793 - 800
Critical Importance and Quality Evaluation of Drug Delivery Autoinjectors in the FDA-DOD Shelf Life Extension Program (SLEP) Saeed R. KhanAdil MohammadPatrick J. Faustino Commentary 11 May 2016 Pages: 801 - 803
Environmental Risk Assessment of Pharmaceutical Mixtures: Demands, Gaps, and Possible Bridges Thomas Backhaus Review Article 04 April 2016 Pages: 804 - 813
The FDA’s Experience with Emerging Genomics Technologies—Past, Present, and Future Joshua XuShraddha ThakkarWeida Tong Review Article Open access 26 April 2016 Pages: 814 - 818
Therapeutic Application of Pharmacogenomics in Oncology Yingqi ZhangSeumsack Dennis SomtakouneXiaodong Feng Review Article 13 May 2016 Pages: 819 - 829
The Effects of Pharmaceutical Excipients on Gastrointestinal Tract Metabolic Enzymes and Transporters—an Update Wenpeng ZhangYanyan LiTao Zhang Review Article 16 May 2016 Pages: 830 - 843
Cell-Based Therapies Formulations: Unintended components Fouad Atouf Mini-Review Open access 27 May 2016 Pages: 844 - 848
Quantifying Trace Amounts of Aggregates in Biopharmaceuticals Using Analytical Ultracentrifugation Sedimentation Velocity: Bayesian Analyses and F Statistics Lucas WaferMarek KloczewiakYin Luo Protocols in Pharmaceutical Sciences Open access 16 May 2016 Pages: 849 - 860
Evolution of Antibody-Drug Conjugate Tumor Disposition Model to Predict Preclinical Tumor Pharmacokinetics of Trastuzumab-Emtansine (T-DM1) Aman P. SinghKatie F. MaassDhaval K. Shah Research Article 30 March 2016 Pages: 861 - 875
Porous Silica-Supported Solid Lipid Particles for Enhanced Solubilization of Poorly Soluble Drugs Rokhsana YasminShasha RaoClive A. Prestidge Research Article 05 April 2016 Pages: 876 - 885
Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin Marilyn MartinezBipin MistryRaafat Fahmy Research Article 26 April 2016 Pages: 886 - 897
Multi-Functional Diarylurea Small Molecule Inhibitors of TRPV1 with Therapeutic Potential for Neuroinflammation Zhiwei FengLarry V. PearceXiang-Qun Xie Research Article 21 March 2016 Pages: 898 - 913
Evolutionary Dynamics of Chronic Myeloid Leukemia Progression: the Progression-Inhibitory Effect of Imatinib Robert C. JacksonTomas Radivoyevitch Research Article 23 March 2016 Pages: 914 - 922
Sorafenib Decreases Tumor Exposure to an Anti-carcinoembryonic Antigen Monoclonal Antibody in a Mouse Model of Colorectal Cancer Veena A. ThomasJoseph P. Balthasar Research Article 30 March 2016 Pages: 923 - 932
Using Physiologically Based Pharmacokinetic (PBPK) Modelling to Gain Insights into the Effect of Physiological Factors on Oral Absorption in Paediatric Populations Angela VilligerCordula StillhartMartin Kuentz Research Article 08 April 2016 Pages: 933 - 947
Mechanism-Based Competitive Binding Model to Investigate the Effect of Neonatal Fc Receptor Binding Affinity on the Pharmacokinetic of Humanized Anti-VEGF Monoclonal IgG1 Antibody in Cynomolgus Monkey Chee M. NgPaul J. FielderRong Deng Research Article 13 April 2016 Pages: 948 - 959
The Use of Cellulose Membrane to Eliminate Burst Release from Intravaginal Rings Ignacio M. HelblingJuan C. D. IbarraJulio A. Luna Research Article 20 April 2016 Pages: 960 - 971
Synthesis and Physicochemical Characterization of a Diethyl Ester Prodrug of DTPA and Its Investigation as an Oral Decorporation Agent in Rats James E. HuckleMatthew P. SadgroveMichael Jay Research Article 22 April 2016 Pages: 972 - 980
Effect of Gastric Fluid Volume on the In Vitro Dissolution and In Vivo Absorption of BCS Class II Drugs: a Case Study with Nifedipine Ahmed M. NaderSara K. QuinneyDavid R. Foster Research Article 22 April 2016 Pages: 981 - 988
Development and Validation of Electrochemiluminescence Assays to Measure Free and Total sSLAMF7 in Human Serum in the Absence and Presence of Elotuzumab Jennifer PostelnekRobert J. NeelySteven P. Piccoli Research Article 26 April 2016 Pages: 989 - 999
PK/PD Modelling of the QT Interval: a Step Towards Defining the Translational Relationship Between In Vitro, Awake Beagle Dogs, and Humans Eleonora MarosticaKarel Van AmmelAn Vermeulen Research Article 26 April 2016 Pages: 1000 - 1012
A Model-Based Approach for Joint Analysis of Pain Intensity and Opioid Consumption in Postoperative Pain Rasmus V JuulKatrine R KnøsgaardTrine M Lund Research Article 26 April 2016 Pages: 1013 - 1022
Dual Outcomes of Rosiglitazone Treatment on Fatty Liver Mingming GaoYongjie MaDexi Liu Research Article 28 April 2016 Pages: 1023 - 1031
Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products Stephanie H. ChoiRobert A. Lionberger Regulatory Note 16 May 2016 Pages: 1032 - 1038
Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches J.-M. CardotA. Garcia ArietaB. Davit Regulatory Note 26 April 2016 Pages: 1039 - 1046