Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team R. J. BriggsR. NicholsonR. W. Abbott White Paper 05 September 2014 Pages: 1143 - 1148
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments Joseph C. MariniMichael AndersonRonald R. Bowsher White Paper 03 October 2014 Pages: 1149 - 1158
Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team Philip TimmermanMark ArnoldTatsuo Kurokawa Editorial 02 October 2014 Pages: 1159 - 1161
Similarities and Differences in Gastrointestinal Physiology Between Neonates and Adults: a Physiologically Based Pharmacokinetic Modeling Perspective Guo YuQing-Shan ZhengGuo-Fu Li Commentary 03 September 2014 Pages: 1162 - 1166
Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team Eric FluhlerFaye VazvaeiDafang Zhong Review Article 19 August 2014 Pages: 1167 - 1174
Next Generation Ligand Binding Assays—Review of Emerging Technologies’ Capabilities to Enhance Throughput and Multiplexing Johanna MoraAllison Given ChunykValerie Theobald Mini-Review 06 September 2014 Pages: 1175 - 1184
Structure, Size, and Solubility of Antigen Arrays Determines Efficacy in Experimental Autoimmune Encephalomyelitis Joshua O. SestakAmir FakhariCory Berkland Research Article 06 September 2014 Pages: 1185 - 1193
A Therapeutic Microparticle-Based Tumor Lysate Vaccine Reduces Spontaneous Metastases in Murine Breast Cancer Brett P. GrossAmaraporn WongrakpanichLyse A. Norian Research Article 16 September 2014 Pages: 1194 - 1203
Co-Delivery of Autoantigen and B7 Pathway Modulators Suppresses Experimental Autoimmune Encephalomyelitis Laura NorthrupJoshua O. SestakCory Berkland Research Article 09 October 2014 Pages: 1204 - 1213
Blocking of JB6 Cell Transformation by Tanshinone IIA: Epigenetic Reactivation of Nrf2 Antioxidative Stress Pathway Ling WangChengyue ZhangAh-Ng Tony Kong Research Article 02 October 2014 Pages: 1214 - 1225
Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry Tomoki YoneyamaTakashi KudoTakahiro Kondo Research Article 15 August 2014 Pages: 1226 - 1236
Population Pharmacokinetic/Pharmacodynamic Modeling of Guanfacine Effects on QTc and Heart Rate in Pediatric Patients William KnebelJames ErmerMarc R. Gastonguay Research Article 19 August 2014 Pages: 1237 - 1246
The Poorly Membrane Permeable Antipsychotic Drugs Amisulpride and Sulpiride Are Substrates of the Organic Cation Transporters from the SLC22 Family Joao N. Dos Santos PereiraSina TadjerpishehMladen V. Tzvetkov Research Article 26 August 2014 Pages: 1247 - 1258
A Semi-mechanistic Model for the Effects of a Novel Glucagon Receptor Antagonist on Glucagon and the Interaction Between Glucose, Glucagon, and Insulin Applied to Adaptive Phase II Design Joanna Z. PengWilliam S. DenneyKen G. Kowalski Research Article 27 August 2014 Pages: 1259 - 1270
Modeling of Bounded Outcome Scores with Data on the Boundaries: Application to Disability Assessment for Dementia Scores in Alzheimer’s Disease Xu Steven XuMahesh SamtaniPartha Nandy Research Article 28 August 2014 Pages: 1271 - 1281
Fmoc-Conjugated PEG-Vitamin E2 Micelles for Tumor-Targeted Delivery of Paclitaxel: Enhanced Drug-Carrier Interaction and Loading Capacity Yifei ZhangYixian HuangSong Li Research Article 06 September 2014 Pages: 1282 - 1291
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies Helmut SchützDetlew LabesAnders Fuglsang Research Article 12 September 2014 Pages: 1292 - 1297
Design and Evaluation of Thioalkylated Mannose-Modified Dendrimer (G3)/α-Cyclodextrin Conjugates as Antigen-Presenting Cell-Selective siRNA Carriers Keiichi MotoyamaRyosuke MitsuyasuHidetoshi Arima Research Article 19 September 2014 Pages: 1298 - 1308
Reliability and Extension of Quantitative Prediction of CYP3A4-Mediated Drug Interactions Based on Clinical Data Constance LoueMichel Tod Research Article 02 October 2014 Pages: 1309 - 1320
Elucidation of Arctigenin Pharmacokinetics After Intravenous and Oral Administrations in Rats: Integration of In Vitro and In Vivo Findings via Semi-mechanistic Pharmacokinetic Modeling Qiong GaoYufeng ZhangZhong Zuo Research Article 02 October 2014 Pages: 1321 - 1333
Prediction of Drug Clearance in Children: an Evaluation of the Predictive Performance of Several Models Iftekhar MahmoodCarl-Michael StaschenKosalaram Goteti Research Article 02 October 2014 Pages: 1334 - 1343
Toward the Establishment of Standardized In Vitro Tests for Lipid-Based Formulations, Part 6: Effects of Varying Pancreatin and Calcium Levels Philip SasseneKaren KlebergAnette Müllertz Research Article 02 October 2014 Pages: 1344 - 1357
The Use of Betaine HCl to Enhance Dasatinib Absorption in Healthy Volunteers with Rabeprazole-Induced Hypochlorhydria Marc R. YagoAdam FrymoyerJoseph A. Ware Research Article 02 October 2014 Pages: 1358 - 1365
Evaluation of Acoustic Membrane Microparticle (AMMP) Technology for a Sensitive Ligand Binding Assay to Support Pharmacokinetic Determinations of a Biotherapeutic Shannon D. ChilewskiW. Matthew DickersonEdward M. Alderman Brief/Technical Note 23 September 2014 Pages: 1366 - 1371
Predicting Pediatric Age-Matched Weight and Body Mass Index Sherwin K. B. SyEduardo Asin-PrietoEmil Samara Brief/Technical Note 26 August 2014 Pages: 1372 - 1379