Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence Michael LuongYing WangBoris Gorovits Research Article 12 March 2020 Article: 56
Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice Bonnie WangLinna WangQin C. Ji Research Article 09 March 2020 Article: 55
Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations Joana MartirTalia FlanaganNikoletta Fotaki Review Article Open access 04 March 2020 Article: 54
A Microfluidic Perfusion Platform for In Vitro Analysis of Drug Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships Yadir A. GuerreroDiti DesaiDerek W. Bartlett Research Article 02 March 2020 Article: 53
Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors Ping HuJie WangYow-Ming C. Wang Research Article 27 February 2020 Article: 52
Physiologically Based Pharmacokinetic Modeling and Tissue Distribution Characteristics of SHetA2 in Tumor-Bearing Mice Ankur SharmaMengjie LiSukyung Woo Research Article 21 February 2020 Article: 51
Bayesian Individual Dynamic Predictions with Uncertainty of Longitudinal Biomarkers and Risks of Survival Events in a Joint Modelling Framework: a Comparison Between Stan, Monolix, and NONMEM François RigletFrance MentreJulie Bertrand Research Article 19 February 2020 Article: 50
Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study—Hypromellose (HPMC) P. ZarmpiT. FlanaganN. Fotaki Research Article Open access 18 February 2020 Article: 49
Model Averaging in Viral Dynamic Models Antonio GonçalvesFrance MentréJérémie Guedj Research Article 13 February 2020 Article: 48
Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products Robert PriceJagdeep ShurSau Lee Research Article Open access 13 February 2020 Article: 47
Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants Panagiota ZarmpiTalia FlanaganNikoletta Fotaki Research Article Open access 11 February 2020 Article: 46
Mechanistic Pharmacokinetic/Pharmacodynamic Model of Sunitinib and Dopamine in MCF-7/Adr Xenografts: Linking Cellular Heterogeneity to Tumour Burden Siyuan WangXiao ZhuTianyan Zhou Research Article 10 February 2020 Article: 45
Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits Helmut SchützDetlew LabesAnders Fuglsang Research Article 07 February 2020 Article: 44
Quantification of T Cell Binding Polyclonal Rabbit Anti-thymocyte Globulin in Human Plasma with Liquid Chromatography Tandem-Mass Spectrometry Mohsin El AmraniRick AdmiraalErik M. van Maarseveen Research Article Open access 06 February 2020 Article: 43
Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays Boris GorovitsMichele FiscellaShobha Purushothama Correction 04 February 2020 Article: 42
Global Sensitivity Analysis of the Rodgers and Rowland Model for Prediction of Tissue: Plasma Partitioning Coefficients: Assessment of the Key Physiological and Physicochemical Factors That Determine Small-Molecule Tissue Distribution Estelle YauAndrés Olivares-MoralesKayode Ogungbenro Research Article 03 February 2020 Article: 41
Application of Reticulocyte-Based Estimation of Red Blood Cell Lifespan in Anemia Management of End-Stage Renal Disease Patients Ly Minh NguyenCalvin J. MeaneyWojciech Krzyzanski Research Article 03 February 2020 Article: 40
Quantitative Assessment of Pulmonary Targeting of Inhaled Corticosteroids Using Ex Vivo Receptor Binding Studies Jie ShaoJames TaltonGuenther Hochhaus Research Article 30 January 2020 Article: 39
Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection Joel A. MathewsYan G. NiGreta Wegner Review Article 29 January 2020 Article: 38
Correction to: Fit-for-Purpose Quality Control System in Continuous Bioanalysis during Long-Term Pediatric Studies Mohsin AliJutta Tinson behalf of LENA consortium Correction 29 January 2020 Article: 37
Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies Zhandong Don ZhongLynn L. JiangLinglong Zou Research Article 29 January 2020 Article: 36
Immunogenicity Risk Assessment for PEGylated Therapeutics Johanna R. MoraJoleen T. WhiteStephen L. DeWall Review Article 28 January 2020 Article: 35
Selection of In Vivo Predictive Dissolution Media Using Drug Substance and Physiological Properties Deanna M. MudieNasim SamieiChristel A.S. Bergström Tutorial Open access 27 January 2020 Article: 34
Investigations of Piperazine Derivatives as Intestinal Permeation Enhancers in Isolated Rat Intestinal Tissue Mucosae V. StuettgenD. J. Brayden Research Article 27 January 2020 Article: 33
Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis Asbjørn Nøhr-NielsenTheis LangeTrine Meldgaard Lund Research Article 27 January 2020 Article: 32
Physiologically Based Pharmacokinetic Modeling and Simulation of Sunitinib in Pediatrics Yanke YuSteven G. DuBoisReza Khosravan Research Article 23 January 2020 Article: 31
Dose Correction for a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model with a Multiple Intravenous Dosing Regimens Xiaoyu YanJuan Jose Perez RuixoWojciech Krzyzanski Research Article 16 January 2020 Article: 30
An Agent-Based Systems Pharmacology Model of the Antibody-Drug Conjugate Kadcyla to Predict Efficacy of Different Dosing Regimens Bruna MenezesCornelius CilliersJennifer J. Linderman Research Article 15 January 2020 Article: 29
Antibody Coadministration as a Strategy to Overcome Binding-Site Barrier for ADCs: a Quantitative Investigation Aman P. SinghLeiming GuoDhaval K. Shah Research Article 14 January 2020 Article: 28
Development of a Population Pharmacokinetics-Based in vitro-in vivo Correlation Model for Drugs with Site-Dependent Absorption: the Acyclovir Case Study Soyoung ShinTae Hwan KimBeom Soo Shin Research Article 14 January 2020 Article: 27
Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development Maxime Le MerdyMing-Liang TanLiang Zhao Research Article 06 January 2020 Article: 26
Expert Discussion of the Role of Rate Constant Versus Clearance Approaches to Define Drug Pharmacokinetics: Theoretical and Clinical Considerations Marilyn N. MartinezRoger W. JelliffeJohannes H. Proost Tutorial 06 January 2020 Article: 25
Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays Boris GorovitsMichele FiscellaShobha Purushothama Review Article 06 January 2020 Article: 24
Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 Diabetes Jason H. WilliamsChandrasekhar UdataXu Meng Research Article Open access 03 January 2020 Article: 23
The Production, Quality Control, and Characterization of ZED8, a CD8-Specific 89Zr-Labeled Immuno-PET Clinical Imaging Agent Herman GillRichard SeipertSimon-Peter Williams Research Article 03 January 2020 Article: 22
The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules Wenzhan YangPrajakta GadgilManuel Sanchez-Felix Review Article 03 January 2020 Article: 21
Estimation of the Effect of OAT2-Mediated Active Uptake on Meloxicam Exposure in the Human Liver Rui LiSumathy MathialaganJohn Litchfield Research Article 03 January 2020 Article: 20
Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population Charles Y. TanGregory S SteenoDaniel J. Baltrukonis Brief/Technical Note 03 January 2020 Article: 19
Polymeric Nanocarrier Formulations of Biologics Using Inverse Flash NanoPrecipitation Chester E. MarkwalterRobert F. PagelsRobert K. Prud’homme Research Article 02 January 2020 Article: 18