AAPS Journal

Article	Citations
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions	214
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease	84
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022	67
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy	48
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies	36
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	35
The Drug Titration Paradox in the Presence of Intra-Individual Variation: Can we Estimate the True Concentration-Effect Relationship?	32
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics	32
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	32
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate	31
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models	30
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy	29
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab	29
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation	28
Gastrointestinal Bile Salt Concentrations in Healthy Adults Under Fasted and Fed Conditions: A Systematic Review and Meta-Analysis for Mechanistic Physiologically-Based Pharmacokinetic (PBPK) Modellin	25
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	25
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	25
A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological T	25
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	25
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development	24
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent	24
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices	23
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	23
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine	23
Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance	23

Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide	22
Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data	22
Investigation of 2,4 Di-tert-butylphenol Leaching from Multidose Ophthalmic Devices into Tacrolimus Micellar Formulations	21
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs	21
A Quantitative Approach to Guiding Target Antigen Selection and Antibody Optimization in Recycling Antibody Discovery	21
A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide	21
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data	21
Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria	20
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	20
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions	19
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies	19
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation	19
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat	18
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	18
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans	17
Lipid Nanoparticles for mRNA Delivery in Cancer Immunotherapy	17
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework	17
New Frontiers in ADC Analysis: Advances in Chromatography, Electrophoresis, and Mass Spectrometry	17
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	17
Drug Dissolution in Oral Drug Absorption: Workshop Report	16
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	16
Flux-Based Formulation Development—A Proof of Concept Study	16
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	15
Regulatory Divergence in Narrow Therapeutic Index Drugs: A Comparative Review of the US, EU, Japan, Canada, and South Korea	15
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling	15
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures	15
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	14
Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity	14
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic	14
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	14
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	14
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions	14
A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume	13
Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development	13
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	13
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	13
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper	13
ICH M10 Bioanalytical Method Validation Guideline-1 year Later	12
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay	12
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence	12
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	12
Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1	12
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver	12
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	12
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology	12
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling	12
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules	12
Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic (TMDD-PD) Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-linear Pharmacokinetics	12
Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP	11
Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review	11

A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing	11
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”	11
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA	11
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models	11
Nitrosamines Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokin	11
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody	11
Leveraging Buprenorphine and Halofantrine as Tool Molecules to Develop a Novel Semi-Physiologically based Pharmacokinetic Model Accounting for Gastro-Intestinal Lymphatic Absorption and Enabling Cross	10
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters	10
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities	10
Meta-Analysis of the Placebo Response in Chronic and Episodic Migraine: Insights from Migraine Preventive Drug Trials	10
In Vitro Assessment of Transporter Mediated Perpetrator DDIs for Several Hepatitis C Virus Direct-Acting Antiviral Drugs and Prediction of DDIs with Statins Using Static Models	10
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site	10
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma	10
Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody–Drug Conjugates	9
Zwitterionic Polymer Coatings Enhance Gold Nanoparticle Stability and Uptake in Various Biological Environments	9
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents	9
RNA Nanomedicine: Delivery Strategies and Applications	9
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	9
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route	9
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications	8
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products	8
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	8
Sinusoidal Organic Anion-Transporting Polypeptide 1B1/1B3 and Bile Canalicular Multidrug Resistance-Associated Protein 2 Play an Essential Role in the Hepatobiliary Disposition of a Synthetic Cyclic D	8
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials	8
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: In Vitro and In Silico Assessment	8
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety	8
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method	8
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation	8
Performance Evaluation of Montelukast Pediatric Formulations: Part II — a PBPK Modelling Approach	7
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability	7
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models	7
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation	7
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder	7
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring	7
Correction: Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	7
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model	7
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?	7
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS	7
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models	7
Machine Learning Predicts Drug Release Profiles and Kinetic Parameters Based on Tablets’ Formulations	7
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays	7
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	7
Does an Intradermal Vaccination for Monkeypox Make Sense?	7
Impacts of Antibody Structure and Mixtures on Receptor Signaling for Antibody-Dependent Cellular Cytotoxicity	7
Lessons from CDER’s Quality Management Maturity Pilot Programs	7
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies	7
Simplifying Pharmacokinetics, Applying it to Drug and Dosage Form Development, and Making Drug Dosage Decisions in Clinical Medicine: The Adaptation of Kirchhoff’s Laws from Physics	6
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants	6
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab	6
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters	6
Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study	6
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary	6
Determination of the Number of Tissue Groups of Kinetically Distinct Transit Time in Whole-Body Physiologically Based Pharmacokinetic (PBPK) Models II: Practical Application of Tissue Lumping Theories	6
Dose Optimization of ClpP Agonists Using an In Vitro Microfluidic Perfusion Platform and In Silico Pharmacokinetic-Pharmacodynamic Modeling	6
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium	6
Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models	6
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors	6
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2	6
Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing	6
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm	6
Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct	6
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	6
Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development	6
IFN-γ/IL-2 Double-Color FluoroSpot Assay for Monitoring Human Primary T Cell Activation: Validation, Inter-Laboratory Comparison, and Recommendations for Clinical Studies	6
Prospects and Challenges of Catechins in Cardiovascular Disease	6
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning	6
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications	6
Investigating Sulfotransferase Mediated Drug Interactions of Ethinylestradiol using a Physiologically Based Pharmacokinetic Model	6
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development	6
Investigations of Influence of Antibody Binding Kinetics on Tumor Distribution and Anti-Tumor Efficacy	6
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	6
Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables?	5
Connexin-Containing Vesicles for Drug Delivery	5
Correction: Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets	5
A Novel Oral Disintegrating Tablet Containing Aprepitant Nanocrystal Developed by Freeze-Drying Technology: An Effective Strategy to Enhance Aprepitant Bioavailability	5
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance	5
Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices	5
Unraveling Ceftriaxone Dosing: Free Drug Prediction, Threshold Optimization, and Model Validation	5
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations	5
Improvement of Drug Release from an Aptamer Drug Conjugate Using Reductive-sensitive Linkers for Tumor-targeted Drug Delivery	5

The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement	5
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications	5
Considerations in Kp,uu,brain-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect	5
Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient	5
Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip® Columns for Sample Pretreatment in an Immunogenicity Assay	5
Physiologically Based Pharmacokinetic Modeling and Simulation in Regulatory Review: US FDA CBER Experience and Perspectives	5
Human Brain Penetration Prediction Using Scaling Approach from Animal Machine Learning Models	5
Fabrication and Characterization of Antibody-Loaded Cationic Porous PLGA Microparticles for Sustained Antibody Release	5
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine	5
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	5
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies	5
Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying	5
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR	5
Pharmacokinetics and Pharmacodynamics of Nomlabofusp in Non-clinical Studies of Friedreich’s Ataxia	4
Correction: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies	4
Substantial Comparability of Singlicate Versus Duplicate Analysis—A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study	4
Tumor Growth Inhibition-Overall Survival (TGI-OS) Model for Subgroup Analysis Based on Post-Randomization Factors: Application for Anti-drug Antibody (ADA) Subgroup Analysis of Atezolizumab in the IMp	4
Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies	4
Correction: Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration	4
Preclinical InVivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T-Cell Bispecific in Combination with Anti-PD-L1	4
Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications	4
Correction: International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines	4
Exploring the Impact of Pharmacological Target-Mediated Low Plasma Exposure in Lead Compound Selection in Drug Discovery – A Modeling Approach	4
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development	4
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution	4
Development of a Near-Infrared Spectroscopy (NIRS)–Based Characterization Approach for Inherent Powder Blend Heterogeneity in Direct Compression Formulations	4
Stability and Function of Extracellular Vesicles Derived from Immortalized Human Corneal Stromal Stem Cells: A Proof of Concept Study	4
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper	4
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research	4
Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan	4
Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations	4
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets	4
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization	4
Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay	4
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile	4
Correction: Cellular Kinetics and Biodistribution of Adoptive T Cell Therapies: from Biological Principles to Effects on Patient Outcomes	4
Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach	4
Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds	4
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy	3
The Impact of Cognate Antigen Binding on the FcRn-mediated Transcytosis and Recycling of Monoclonal Antibodies	3
Impact of Weak Vibration Generated by a Refrigerator on Protein Aggregation	3
Virtual Bioequivalence Assessment of Tofacitinib Once Daily Modified Release Dosage Form in Pediatric Subjects	3
Effective Visualizations Using “vachette” to Assess and Communicate Pharmacometric Model Results	3
Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics	3
Enhanced Pharmacokinetic Bioanalysis of Antibody–drug Conjugates using Hybrid Immunoaffinity Capture and Microflow LC-MS/MS	3
Pharmacokinetics of Gentamicin Components C1, C1a, and C2/C2a/C2b and Subsequent Decline in Glomerular Filtration Rate in Neonates	3
Nonclinical Pharmacokinetics, Pharmacodynamics, and Translational Model of RO7297089, A Novel Anti-BCMA/CD16A Bispecific Tetravalent Antibody for the Treatment of Multiple Myeloma	3
Determination of the Number of Tissue Groups of Kinetically Distinct Transit Time in Whole-Body Physiologically Based Pharmacokinetic (PBPK) Models I: Theoretical Consideration of Bottom-Up Approach o	3
One-step Immobilization of Human α-1-acid Glycoprotein on Magnetic Beads: A Rapid Method for Small Molecule hAGP Binding Study	3
Correction to: Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics	3
Publisher Correction: Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models	3
A Microemulsion for Oral Delivery of Nintedanib – QbD-Enabled Formulation Development, In-Vitro Characterization & In-Vivo Pharmacokinetic Assessment	3
Effect of Physicochemical Properties on the Basic Drug-Acid-Polymer Interactions and Miscibility in PVA Based Orodispersible Films	3
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience	3
Real-Time Tracking of In Situ-Forming Alginate Hydrogel by Contrast-Enhanced Computed Tomography	3
Doxorubicin Stability-indicating Method and its Main Degradation Products In vitro Toxicity	3
Biomarker Assay Validation by Mass Spectrometry	3
Removal of Excipients from Drug Product may Impact Antibody Characterization of Monoclonal Antibodies	3
Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan	3
Correction: Tumor-Targeted Chemoimmunotherapy with Immune-Checkpoint Blockade for Enhanced Anti-Melanoma Efficacy	3
Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products	3
Application of Solubility and Dissolution Profile Comparison for Prediction of Gastric pH-Mediated Drug-Drug Interactions	3
Machine Learning Prediction of Clinical Trial Operational Efficiency	3
Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates	3
Addressing Domain Specificity in the Development of a Cell-Based Binding Assay for the Detection of Neutralizing Antibodies Against a CD47xPD-L1 Bispecific Antibody	3
Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m6A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway	3
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop	3
Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity	3
Correction: A Tangeretin Derivative Inhibits the Growth of Human Prostate Cancer LNCaP Cells by Epigenetically Restoring p21 Gene Expression and Inhibiting Cancer Stem-like Cell Proliferation	3
Analytical Quality by Design, Life Cycle Management, and Method Control	3
Gastrointestinal Delivery of an mRNA Vaccine Using Immunostimulatory Polymeric Nanoparticles	3
A Short Update on the Use of Monoclonal Antibodies in COVID-19	3
Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies	3
Social Inequality and Antimicrobial Resistance: An Interconnected Global Problem	3
Comparative Evaluation of Approaches to Convert Microsampled Capillary Blood Concentrations to Plasma Concentrations: Paracetamol and Metabolites as a Case Study	3
Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us?	3
The Use of Surrogate Matrix for Calibrators in the Analysis of Dried Blood Samples – A Feasibility Study	3
Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making	3
Neutralizing Antibody Sample Testing and Report Harmonization	2
Correction: Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates	2
Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039	2
Liposomal Formulations of Anti-Alzheimer Drugs and siRNA for Nose-to-Brain Delivery: Design, Safety and Efficacy In Vitro	2
UGT2B10 is the Major UDP-Glucuronosyltransferase 2B Isoform Involved in the Metabolism of Lamotrigine and is Implicated in the Drug-Drug Interaction with Valproic Acid	2
Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass	2
Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels	2
An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing	2
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling	2
Letter to the Editor on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”	2
Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans	2
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials	2
Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir	2
Targeting Macrophages for Tumor Therapy	2
A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia	2
A Comparative Study on Physicochemical and Analytical Characterizations of Doxil® and its Generic Drug Products	2
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products	2