AAPS Journal

Article	Citations
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics	415
Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19	314
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects	241
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	96
FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes	78
Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential	54
Cannabinoid Interactions with Cytochrome P450 Drug Metabolism: a Full-Spectrum Characterization	50
γ-Hydroxybutyric Acid: Pharmacokinetics, Pharmacodynamics, and Toxicology	43
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities	42
Analytical Quality by Design, Life Cycle Management, and Method Control	37
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs	33
State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References	31
Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization	31
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays	29
Applications of Nanoparticle-Antibody Conjugates in Immunoassays and Tumor Imaging	29
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models	29
Extracellular Vesicles in Oncology: from Immune Suppression to Immunotherapy	28
The Role of Alcohol Dehydrogenase in Drug Metabolism: Beyond Ethanol Oxidation	28
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review	28
Anti-drug Antibody Validation Testing and Reporting Harmonization	26
Albumin-Mediated Uptake Improves Human Clearance Prediction for Hepatic Uptake Transporter Substrates Aiding a Mechanistic In Vitro-In Vivo Extrapolation (IVIVE) Strategy in Discovery Research	26
Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach	25
Development of Lipidoid Nanoparticles for siRNA Delivery to Neural Cells	24
Exosomes in Atherosclerosis, a Double-Edged Sword: Their Role in Disease Pathogenesis and Their Potential as Novel Therapeutics	24
A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy	22

Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker	22
There is Only One Valid Definition of Clearance: Critical Examination of Clearance Concepts Reveals the Potential for Errors in Clinical Drug Dosing Decisions	22
Employing Drug Delivery Strategies to Overcome Challenges Using TLR7/8 Agonists for Cancer Immunotherapy	20
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective	20
Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions	20
Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds	20
Translational CNS Steady-State Drug Disposition Model in Rats, Monkeys, and Humans for Quantitative Prediction of Brain-to-Plasma and Cerebrospinal Fluid-to-Plasma Unbound Concentration Ratios	20
The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution	19
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines	18
Insights on Droplet Digital PCR–Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy	18
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes	18
Choroid Plexus and Drug Removal Mechanisms	18
Evaluation of Excipient Risk in BCS Class I and III Biowaivers	17
Assessment of the Kochak-Benet Equation for Hepatic Clearance for the Parallel-Tube Model: Relevance of Classic Clearance Concepts in PK and PBPK	17
Formoterol PLGA-PEG Nanoparticles Induce Mitochondrial Biogenesis in Renal Proximal Tubules	16
Age-Related Changes in Pediatric Physiology: Quantitative Analysis of Organ Weights and Blood Flows	16
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	16
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Ph	16
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus	16
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	15
Spinach and Chive for Kidney Tubule Engineering: the Limitations of Decellularized Plant Scaffolds and Vasculature	15
Immunogenicity Risk Assessment for Multi-specific Therapeutics	15
Perspectives on Existing and Novel Alternative Intravaginal Probiotic Delivery Methods in the Context of Bacterial Vaginosis Infection	15
Evaluation of Microparticulate (S)-4,5-Dihydroxy-2,3-pentanedione (DPD) as a Potential Vaccine Adjuvant	15
Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine	15
Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences that Impact Drug Pharmacokinetics	15
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms	15
A Two-Pore Physiologically Based Pharmacokinetic Model to Predict Subcutaneously Administered Different-Size Antibody/Antibody Fragments	14
Translational Modeling of Anticancer Efficacy to Predict Clinical Outcomes in a First-in-Human Phase 1 Study of MDM2 Inhibitor HDM201	14
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy	14
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations	14
Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey	14
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	14
In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition	13
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?	13
The Nano-War Against Complement Proteins	13
Anthracycline-Induced Cardiotoxicity: Molecular Insights Obtained from Human-Induced Pluripotent Stem Cell–Derived Cardiomyocytes (hiPSC-CMs)	13
Inhalable Nanoparticles/Microparticles of an AMPK and Nrf2 Activator for Targeted Pulmonary Drug Delivery as Dry Powder Inhalers	13
Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters	13
Quantitative Evaluation of the Effect of Antigen Expression Level on Antibody–Drug Conjugate Exposure in Solid Tumor	13
Skin Penetration Enhancement Strategies Used in the Development of Melanoma Topical Treatments	13
Pharmacokinetic Analysis of Peptide-Modified Nanoparticles with Engineered Physicochemical Properties in a Mouse Model of Traumatic Brain Injury	12
The effects of all-trans retinoic acid on immune cells and its formulation design for vaccines	12
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	12
Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials	12
Metabolism of Speciociliatine, an Overlooked Kratom Alkaloid for its Potential Pharmacological Effects	12
Dosing Recommendations for Vancomycin in Children and Adolescents with Varying Levels of Obesity and Renal Dysfunction: a Population Pharmacokinetic Study in 1892 Children Aged 1–18 Years	12
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling	12
Oil-Immersion Flow Imaging Microscopy for Quantification and Morphological Characterization of Submicron Particles in Biopharmaceuticals	11
Iontophoresis to Overcome the Challenge of Nail Permeation: Considerations and Optimizations for Successful Ungual Drug Delivery	11

A Systematic Approach for Liposome and Lipodisk Preclinical Formulation Development by Microfluidic Technology	11
Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group	11
Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies	11
Elucidating the Effect of Fine Lactose Ratio on the Rheological Properties and Aerodynamic Behavior of Dry Powder for Inhalation	11
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	10
An Integrated Analysis of Dostarlimab Immunogenicity	10
Assessment of Drug Delivery Kinetics to Epidermal Targets In Vivo	10
Microfluidic-Generated Immunomodulatory Nanoparticles and Formulation-Dependent Effects on Lipopolysaccharide-Induced Macrophage Inflammation	10
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends	10
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	10
Evidence-Based Guidelines for Drug Interaction Studies: Model-Informed Time Course of Intestinal and Hepatic CYP3A4 Inhibition by Clarithromycin	9
Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein	9
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D?	9
Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry	9
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium	9
Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics	9
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates	9
Lipid Nanoparticle-Enabled Intracellular Delivery of Prime Editors	9
The Evolution of Single-Cell Analysis and Utility in Drug Development	9
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	9
Immunoglobulin G Is a Novel Substrate for the Endocytic Protein Megalin	8
Neutralizing Antibody Validation Testing and Reporting Harmonization	8
Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy	8
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	8
Drug Dissolution in Oral Drug Absorption: Workshop Report	8
Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties	8
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	8
Nfe2l2 Regulates Metabolic Rewiring and Epigenetic Reprogramming in Mediating Cancer Protective Effect by Fucoxanthin	8
Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions	8
Human Fetal Liver Metabolism of Oxycodone Is Mediated by CYP3A7	8
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications	8
Monoclonal Antibody Reagent Stability and Expiry Recommendation Combining Experimental Data with Mathematical Modeling	8
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	8
Biomarker Assay Validation by Mass Spectrometry	8
Recent Advances in 3D Printing for Parenteral Applications	7
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development	7
PBPK Simulation-Based Evaluation of Ganciclovir Crystalluria Risk Factors: Effect of Renal Impairment, Old Age, and Low Fluid Intake	7
Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir	7
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	7
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow	7
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	7
Incorporating Breastfeeding-Related Variability with Physiologically Based Pharmacokinetic Modeling to Predict Infant Exposure to Maternal Medication Through Breast Milk: a Workflow Applied to Lamotri	7
Estimation of Ontogeny Functions for Renal Transporters Using a Combined Population Pharmacokinetic and Physiology-Based Pharmacokinetic Approach: Application to OAT1,3	7
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations	7
Direct Comparison of the Prediction of the Unbound Brain-to-Plasma Partitioning Utilizing Machine Learning Approach and Mechanistic Neuropharmacokinetic Model	7
Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review	7
Reactive Oxygen Species–Responsive Celastrol-Loaded Bilirubin Nanoparticles for the Treatment of Rheumatoid Arthritis	7
Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension	7
Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs	6
Modulating Oral Delivery and Gastrointestinal Kinetics of Recombinant Proteins via Engineered Fungi	6
Zwitterionic Polymer Coatings Enhance Gold Nanoparticle Stability and Uptake in Various Biological Environments	6
Bioanalysis in the Age of New Drug Modalities	6
Gastrointestinal Delivery of an mRNA Vaccine Using Immunostimulatory Polymeric Nanoparticles	6
Predicting Food Effects: Are We There Yet?	6
Pancreatic Cancer: Recent Progress of Drugs in Clinical Trials	6
Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration	6
Machine Learning Prediction of Clinical Trial Operational Efficiency	6
Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies	6
Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration	6
Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)	5
Anti-drug Antibody Sample Testing and Reporting Harmonization	5
Flux-Based Formulation Development—A Proof of Concept Study	5
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development	5
Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products	5
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience	5
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	5
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	5
A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption	5
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	5
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	5
A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products	5
Nano/microparticle Formulations for Universal Influenza Vaccines	5
Stability and Function of Extracellular Vesicles Derived from Immortalized Human Corneal Stromal Stem Cells: A Proof of Concept Study	5
Targeting Macrophages for Tumor Therapy	5
Comparison of Hepatic Transporter Tissue Expression in Rodents and Interspecies Hepatic OCT1 Activity	5
ICH Q10 Pharmaceutical Quality System Guidance: Understanding Its Impact on Pharmaceutical Quality	5
Application of Model Informed Precision Dosing to Address the Impact of Pregnancy Stage and CYP2D6 Phenotype on Foetal Morphine Exposure	5
Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum	5
Therapeutic Fusion Proteins	5
Phish-Pharm: A Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish — 2022 Update	5

Pulmonary Delivery of Aerosolized Chloroquine and Hydroxychloroquine to Treat COVID-19: In Vitro Experimentation to Human Dosing Predictions	5
Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study	5
Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039	5
Cluster Gauss–Newton and CellNOpt Parameter Estimation in a Small Protein Signaling Network of Vorinostat and Bortezomib Pharmacodynamics	4
Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation	4
Multiscale and Translational Quantitative Systems Toxicology, Pharmacokinetic-Toxicodynamic Modeling Analysis for Assessment of Doxorubicin-Induced Cardiotoxicity	4
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization	4
Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease	4
A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood	4
Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective	4
Mini-PBPK-Based Population Model and Covariate Analysis to Assess the Complex Pharmacokinetics and Pharmacodynamics of RO7449135, an Anti-KLK5/KLK7 Bispecific Antibody in Cynomolgus Monkeys	4
Efficacy and Safety Exposure–Response Analysis of Loncastuximab Tesirine in Patients with B cell non-Hodgkin Lymphoma	4
Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics	4
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials	4
Enhanced Pharmacokinetic Bioanalysis of Antibody–drug Conjugates using Hybrid Immunoaffinity Capture and Microflow LC-MS/MS	4
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development	4
Monoclonal Antibody Pharmacokinetics in Cynomolgus Monkeys Following Subcutaneous Administration: Physiologically Based Model Predictions from Physiochemical Properties	4
Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets	4
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	4
Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis	4
Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays	4
Risk Factors, Hyaluronidase Expression, and Clinical Immunogenicity of Recombinant Human Hyaluronidase PH20, an Enzyme Enabling Subcutaneous Drug Administration	4
Pharmacokinetics of Monoclonal Antibody and Antibody Fragments in the Mouse Eye Following Systemic Administration	4
Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation	4
Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)8-Paclitaxel Prodrug Loaded Polymeric Micelles	4
Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release)	4
Predicting Chemotherapy-Induced Neutropenia and Granulocyte Colony–Stimulating Factor Response Using Model-Based In Vitro to Clinical Translation	4
A Novel Approach for Quantifying the Pharmacological Activity of T-Cell Engagers Utilizing In Vitro Time Course Experiments and Streamlined Data Analysis	4
Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study	4
Nonclinical Pharmacokinetics, Pharmacodynamics, and Translational Model of RO7297089, A Novel Anti-BCMA/CD16A Bispecific Tetravalent Antibody for the Treatment of Multiple Myeloma	4
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS	4
A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer The	4
Developing Tools to Evaluate Non-linear Mixed Effect Models: 20 Years on the npde Adventure	4
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	4
Towards Evidence-Based Weaning: a Mechanism-Based Pharmacometric Model to Characterize Iatrogenic Withdrawal Syndrome in Critically Ill Children	4
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat	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
Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics	3
Novel Cell Quantification Method Using a Single Surrogate Calibration Curve Across Various Biological Samples	3
Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery	3
An Item Response Theory–Informed Strategy to Model Total Score Data from Composite Scales	3
Assessing Food Effects on Oral Drug Absorption Based on the Degree of Renal Excretion	3
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	3
Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners	3
Targeted Delivery of Endosomal Escape Peptides to Enhance Immunotoxin Potency and Anti-cancer Efficacy	3
The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement	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
Ionic Liquid-Based Transcutaneous Peptide Antitumor Vaccine: Therapeutic Effect in a Mouse Tumor Model	3
Parent and Metabolite Concentration-QT Modeling to Evaluate QT-Interval Prolongation at Savolitinib Therapeutic Doses	3
NIR Spectroscopy as an Online PAT Tool for a Narrow Therapeutic Index Drug: Toward a Platform Approach Across Lab and Pilot Scales for Development of a Powder Blending Monitoring Method and Endpoint D	3
Network-Based Systems Analysis Explains Sequence-Dependent Synergism of Bortezomib and Vorinostat in Multiple Myeloma	3
Population Pharmacodynamic Modeling Using the Sigmoid Emax Model: Influence of Inter-individual Variability on the Steepness of the Concentration–Effect Relationship. a Simulation Study	3
Real-Time Tracking of In Situ-Forming Alginate Hydrogel by Contrast-Enhanced Computed Tomography	3
Determinants of Biological Half-Lives and Terminal Slopes in Physiologically Based Pharmacokinetic Systems: Assessment of Limiting Conditions	3
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	3
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications	3
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report	3
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence	3
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	3
An Artificial Gut/Absorption Simulator: Description, Modeling, and Validation Using Caffeine	3
AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived Antibodies	3
Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System	3
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	3
Systems Modeling to Quantify Safety Risks in Early Drug Development: Using Bifurcation Analysis and Agent-Based Modeling as Examples	3
Development and Validation of a Western Blot Method to Quantify Mini-Dystrophin in Human Skeletal Muscle Biopsies	3
A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development	3
Best Practices in mAb and Soluble Target Assay Selection for Quantitative Modelling and Qualitative Interpretation	3
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper	3
Neutralization Activity of Anti-drug Antibodies Against a Biotherapeutic Can Be Predicted from a Comprehensive Pharmacokinetics, Pharmacodynamics, and Anti-drug Antibody Data Analysis	3
Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics	3
A Novel Neutralization Antibody Assay Method to Overcome Drug Interference with Better Compatibility with Acid-Sensitive Neutralizing Antibodies	3
Human Brain Penetration Prediction Using Scaling Approach from Animal Machine Learning Models	3
RNA Nanomedicine: Delivery Strategies and Applications	3
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures	3
Stochastic Differential Equation-based Mixed Effects Model of the Fluid Volume in the Fasted Stomach in Healthy Adult Human	3
Application of Solubility and Dissolution Profile Comparison for Prediction of Gastric pH-Mediated Drug-Drug Interactions	3
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial	3