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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products Fang WuYoussef MousaLiang Zhao Review Article 24 January 2024 Article: 19
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay Veronica LiuKelly McGrathYong Jiang Research Article 24 January 2024 Article: 18
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model Anas SaadeddinVivek PurohitKazuko Sagawa Research Article Open access 24 January 2024 Article: 17
Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies Audrey ArjomandiKetevan SiradzeSaloumeh K. Fischer Research Article 24 January 2024 Article: 16
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development Yuqing GongFrancis-Xavier BarrettoLiang Zhao Meeting Report 24 January 2024 Article: 15
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report Eleftheria TsakalozouLanyan FangLiang Zhao Meeting Report 10 January 2024 Article: 14
Building a Predictive PBPK Model for Human OATP Substrates: a Strategic Framework for Early Evaluation of Clinical Pharmacokinetic Variations Using Pitavastatin as an Example Xiaomin LiangMegan L. KoleskeYurong Lai Research Article 05 January 2024 Article: 13
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products Ross L. WalengaAndrew H. BabiskinPartha Roy Meeting Report 04 January 2024 Article: 12
A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK Ran LiEdward DereMeric A. Ovacik Research Article Open access 02 January 2024 Article: 11
Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape Satish G. JadhavRyan L. SettenSteven F. Dowdy Brief/Technical Note 22 December 2023 Article: 10
Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffinity LC–MS Maoyin LiAudrey ArjomandiKeyang Xu Research Article Open access 19 December 2023 Article: 9
Notes on the Use of Kirchhoff’s Laws in Pharmacokinetics Ronald A. Siegel Commentary 19 December 2023 Article: 8
Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19 Michelle StaffordRachel Linck DunnAlex Viehmann Research Article 19 December 2023 Article: 7
Correction to: Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics Kirk HaltaufderhydeBrian J. RobertsAnne S. De Groot Correction Open access 19 December 2023 Article: 6
Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing Ankur SharmaXin LiuSukyung Woo Research Article Open access 12 December 2023 Article: 5
A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia Wojciech KrzyzanskiPia WintermarkKarel Allegaert Research Article Open access 05 December 2023 Article: 4
Therapeutic Fusion Proteins Morgan C. MarshShawn C. Owen Review Article-theme 30 November 2023 Article: 3
Correction: A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications Shiny Amala Priya RajanJason SherfeyMurat Cirit Correction Open access 20 November 2023 Article: 2
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development Hester KramerCeyhun BicerHugues Chanteux Research Article Open access 16 November 2023 Article: 1
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables” Huybrecht T’jollynOliver Ackaert Editorial 14 November 2023 Article: 104
Drug Dissolution in Oral Drug Absorption: Workshop Report Kimberly RainesPayal AgarwalJames E. Polli Meeting Report Open access 07 November 2023 Article: 103
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications Shiny Amala Priya RajanJason SherfeyMurat Cirit Research Article Open access 27 October 2023 Article: 102
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors Tao ZhangPeng Zou Research Article 27 October 2023 Article: 101
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications Ashbey N. ManningClaire E. RowlandsBrittany E. Givens Research Article 27 October 2023 Article: 100
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development Maxime SiemonsBram SchroyenNavin Goyal Review Article Open access 17 October 2023 Article: 99
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans Li Di Research Article 05 October 2023 Article: 98
An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody Van NguyenAnthony CheungShan Chung Research Article 02 October 2023 Article: 97
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RNA Nanomedicine: Delivery Strategies and Applications Junho ByunYina WuYu-Kyoung Oh Review Article-theme 02 October 2023 Article: 95
Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery Catherine SaundersCamille A. de VilliersMolly M. Stevens Review Article-theme Open access 02 October 2023 Article: 94
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance Xinyuan LiShan HeMichael Swanson Research Article 28 September 2023 Article: 93
Fabrication and Characterization of Antibody-Loaded Cationic Porous PLGA Microparticles for Sustained Antibody Release Ayaka HanakiKoki OgawaTetsuya Ozeki Research Article 22 September 2023 Article: 92
Addressing Domain Specificity in the Development of a Cell-Based Binding Assay for the Detection of Neutralizing Antibodies Against a CD47xPD-L1 Bispecific Antibody Michael LuongYing WangChristopher Lepsy Research Article Open access 22 September 2023 Article: 91
Phase-appropriate Application of Process Analytical Technology for Early Pharmaceutical Development of Oral Solid Dosage Forms—the Case Study of Uniformity Screening of Dosage Units and Blends Sayyeda Zeenat RazviShengli MaZhenqi (Pete) Shi Research Article 15 September 2023 Article: 90
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Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters Asahi AdachiTomoki YamashitaYohei Kosugi Research Article Open access 12 September 2023 Article: 88
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Human Brain Penetration Prediction Using Scaling Approach from Animal Machine Learning Models Siyu LiuYohei Kosugi Research Article Open access 05 September 2023 Article: 86
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study Fred McCushEllen WangDaniel Baltrukonis Research Article 02 September 2023 Article: 85
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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper Uma KavitaKefeng SunNagendra Chemuturi Review Article 31 July 2023 Article: 78
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