Investigating the Theoretical Basis for In Vitro–In Vivo Extrapolation (IVIVE) in Predicting Drug Metabolic Clearance and Proposing Future Experimental Pathways Leslie Z. BenetJasleen K. Sodhi Commentary 10 September 2020 Article: 120
Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability Jonathan BodinStéphanie LiandratCéline Petitcolas Research Article Open access 10 September 2020 Article: 119
HIV-1 Sanctuary Sites—the Role of Membrane-Associated Drug Transporters and Drug Metabolic Enzymes Sana-Kay Whyte-AllmanReina Bendayan Review Article 01 September 2020 Article: 118
A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation Michael J. DoltonPo-Chang ChiangYuan Chen Research Article 01 September 2020 Article: 117
Inter-compound and Intra-compound Global Sensitivity Analysis of a Physiological Model for Pulmonary Absorption of Inhaled Compounds Nicola MelilloSilvia GrandoniPaolo Magni Research Article Open access 30 August 2020 Article: 116
Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia Yassine Kamal LyaukDaniël M. JonkerMats O. Karlsson Research Article Open access 27 August 2020 Article: 115
Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk Dilki WickramarachchiGregory SteenoLi Xue Research Article 24 August 2020 Article: 114
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products Ioannis Loisios-KonstantinidisBart HensRodrigo Cristofoletti Research Article 23 August 2020 Article: 113
Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data Michael A. PartridgeElif Kabuloglu KarayusufGiane Sumner Research Article 17 August 2020 Article: 112
The Necessity of Using Changes in Absorption Time to Implicate Intestinal Transporter Involvement in Oral Drug-Drug Interactions Jasleen K. SodhiLeslie Z. Benet Research Article 17 August 2020 Article: 111
Pitfalls in Predicting Hepatobiliary Drug Transport Using Human Sandwich-Cultured Hepatocytes Vineet KumarCindy Yanfei LiJashvant D. Unadkat Research Article 17 August 2020 Article: 110
A Three-Treatment Two-Stage Design for Selection of a Candidate Formulation and Subsequent Demonstration of Bioequivalence Anders Fuglsang Research Article 14 August 2020 Article: 109
Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance Meng HuXiaohui JiangRobert Lionberger Correction 14 August 2020 Article: 108
Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations Lei MiaoYoussef M. MousaFang Wu Research Article 10 August 2020 Article: 107
Challenge-Enabled Machine Learning to Drug-Response Prediction Ziyan WangHongyang LiYuanfang Guan Mini-Review 10 August 2020 Article: 106
Capturing the Magic Bullet: Pharmacokinetic Principles and Modeling of Antibody-Drug Conjugates Peiying Zuo Review Article 06 August 2020 Article: 105
Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira® Matthew AlleynKristin ClossonPaul Rhyne Research Article Open access 03 August 2020 Article: 104
Association Between Vomiting and QT Hysteresis: Data from a TQT Study with the Endothelin A Receptor Antagonist Clazosentan Pierre-Eric JuifJasper DingemanseMike Ufer Research Article 03 August 2020 Article: 103
Correction to: Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Additional Benefit Duxin Sun Correction 02 August 2020 Article: 102
Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver Peijuan ZhuChyi-Hung HsuHonghui Zhou Tutorial 02 August 2020 Article: 101
A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products Steve Y. RhieuDavid D. AndersonKumar Janoria Regulatory Note 02 August 2020 Article: 100
The Effects of Dose Volume and Excipient Dose on Luminal Concentration and Oral Drug Absorption Bruce J. Aungst Mini-Review 31 July 2020 Article: 99
Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia Yassine Kamal LyaukTrine Meldgaard LundDaniël M. Jonker Research Article Open access 29 July 2020 Article: 98
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products Arzu SelenAnette MüllertzTalia Flanagan Commentary 27 July 2020 Article: 97
PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy Feifan XieJan Van BocxlaerAn Vermeulen Research Article 24 July 2020 Article: 96
Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data Chuanpu HuHonghui ZhouAmarnath Sharma Research Article 21 July 2020 Article: 95
Discovery of a Highly Selective Sigma-2 Receptor Ligand, 1-(4-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)butyl)-3-methyl-1H-benzo[d]imidazol-2(3H)-one (CM398), with Drug-Like Properties and Antinociceptive Effects In Vivo Sebastiano IntagliataAbhisheak SharmaChristopher R. McCurdy Research Article 20 July 2020 Article: 94
Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models Dan LiuLinzhong LiMasoud Jamei Research Article Open access 17 July 2020 Article: 93