AAPS Journal

Article	Citations
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics	353
Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19	280
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects	174
Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Aditional Benefit	88
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	61
FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes	58
Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective	48
Protein Corona-Enabled Systemic Delivery and Targeting of Nanoparticles	41
A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin	40
Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential	38
Cannabinoid Interactions with Cytochrome P450 Drug Metabolism: a Full-Spectrum Characterization	35
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities	35
Physiologically Based Absorption Modelling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Entrectinib	34
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 Antino	32
γ-Hydroxybutyric Acid: Pharmacokinetics, Pharmacodynamics, and Toxicology	32
Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models	30
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs	27
Development and Application of a Physiologically-Based Pharmacokinetic Model to Predict the Pharmacokinetics of Therapeutic Proteins from Full-term Neonates to Adolescents	25
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays	25
Identification and Utilization of Biomarkers to Predict Response to Immune Checkpoint Inhibitors	24
Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization	24
Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations	24
A Quantitative Systems Pharmacology Model of T Cell Engager Applied to Solid Tumor	24
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models	24
Applications of Nanoparticle-Antibody Conjugates in Immunoassays and Tumor Imaging	23

Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®	23
Intracellular ABCB1 as a Possible Mechanism to Explain the Synergistic Effect of Hydroxychloroquine-Azithromycin Combination in COVID-19 Therapy	23
Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach	23
The Role of Alcohol Dehydrogenase in Drug Metabolism: Beyond Ethanol Oxidation	22
Investigating the Theoretical Basis for In Vitro–In Vivo Extrapolation (IVIVE) in Predicting Drug Metabolic Clearance and Proposing Future Experimental Pathways	21
Extracellular Vesicles in Oncology: from Immune Suppression to Immunotherapy	21
Development of Lipidoid Nanoparticles for siRNA Delivery to Neural Cells	21
Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker	21
State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References	21
In Vitro and In Vivo Efficacy of AZD3965 and Alpha-Cyano-4-Hydroxycinnamic Acid in the Murine 4T1 Breast Tumor Model	20
Analytical Quality by Design, Life Cycle Management, and Method Control	20
There is Only One Valid Definition of Clearance: Critical Examination of Clearance Concepts Reveals the Potential for Errors in Clinical Drug Dosing Decisions	19
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective	19
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report	18
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review	18
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	18
Exosomes in Atherosclerosis, a Double-Edged Sword: Their Role in Disease Pathogenesis and Their Potential as Novel Therapeutics	17
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	17
In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes	17
A Microfluidic Perfusion Platform for In Vitro Analysis of Drug Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships	17
Construction and Verification of Physiologically Based Pharmacokinetic Models for Four Drugs Majorly Cleared by Glucuronidation: Lorazepam, Oxazepam, Naloxone, and Zidovudine	16
The Influence of Drug Properties and Ontogeny of Transporters on Pediatric Renal Clearance through Glomerular Filtration and Active Secretion: a Simulation-Based Study	16
Employing Drug Delivery Strategies to Overcome Challenges Using TLR7/8 Agonists for Cancer Immunotherapy	16
A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy	15
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	15
The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution	15
Development of a FRET-Based Assay for Analysis of mAbs Internalization and Processing by Dendritic Cells in Preclinical Immunogenicity Risk Assessment	15
Anti-drug Antibody Validation Testing and Reporting Harmonization	15
Drug Absorption Parameters Obtained Using the Isolated Perfused Rat Lung Model Are Predictive of Rat In Vivo Lung Absorption	15
Assessment of the Kochak-Benet Equation for Hepatic Clearance for the Parallel-Tube Model: Relevance of Classic Clearance Concepts in PK and PBPK	15
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines	15
Evaluation of Excipient Risk in BCS Class I and III Biowaivers	15
Insights on Droplet Digital PCR–Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy	15
Choroid Plexus and Drug Removal Mechanisms	14
Machine Learning Analysis of Individual Tumor Lesions in Four Metastatic Colorectal Cancer Clinical Studies: Linking Tumor Heterogeneity to Overall Survival	14
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus	14
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?	13
Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions	13
Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection	13
Formoterol PLGA-PEG Nanoparticles Induce Mitochondrial Biogenesis in Renal Proximal Tubules	13
Age-Related Changes in Pediatric Physiology: Quantitative Analysis of Organ Weights and Blood Flows	13
Challenge-Enabled Machine Learning to Drug-Response Prediction	13
Modeling Temperature-Dependent Dermal Absorption and Clearance for Transdermal and Topical Drug Applications	13
Capturing the Magic Bullet: Pharmacokinetic Principles and Modeling of Antibody-Drug Conjugates	12
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	12
Impact of Magnesium Stearate Presence and Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties	12
Spinach and Chive for Kidney Tubule Engineering: the Limitations of Decellularized Plant Scaffolds and Vasculature	12
Clinical Immunogenicity Risk Assessment for a Fusion Protein	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
Translational Modeling of Anticancer Efficacy to Predict Clinical Outcomes in a First-in-Human Phase 1 Study of MDM2 Inhibitor HDM201	12

Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations	12
Evaluation of Microparticulate (S)-4,5-Dihydroxy-2,3-pentanedione (DPD) as a Potential Vaccine Adjuvant	12
Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds	12
Inhalable Nanoparticles/Microparticles of an AMPK and Nrf2 Activator for Targeted Pulmonary Drug Delivery as Dry Powder Inhalers	12
Bioanalytical Challenges in Support of Complex Modalities of Antibody-Based Therapeutics	12
Comparison of Alternative Population Modeling Approaches for Implementing a Level A IVIVC and for Assessing the Time-Scaling Factor Using Deconvolution and Convolution-Based Methods	11
Perspectives on Existing and Novel Alternative Intravaginal Probiotic Delivery Methods in the Context of Bacterial Vaginosis Infection	11
Comparison of Fraction Unbound Between Liver Homogenate and Hepatocytes at 4°C	11
Pharmacokinetic Analysis of Peptide-Modified Nanoparticles with Engineered Physicochemical Properties in a Mouse Model of Traumatic Brain Injury	11
Anthracycline-Induced Cardiotoxicity: Molecular Insights Obtained from Human-Induced Pluripotent Stem Cell–Derived Cardiomyocytes (hiPSC-CMs)	11
HIV-1 Sanctuary Sites—the Role of Membrane-Associated Drug Transporters and Drug Metabolic Enzymes	11
Skin Penetration Enhancement Strategies Used in the Development of Melanoma Topical Treatments	11
Oil-Immersion Flow Imaging Microscopy for Quantification and Morphological Characterization of Submicron Particles in Biopharmaceuticals	11
Land O’Lakes Workshop on Microsampling: Enabling Broader Adoption	11
Applying Beta Distribution in Analyzing Bounded Outcome Score Data	10
Assessment of Drug Delivery Kinetics to Epidermal Targets In Vivo	10
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms	10
Population Pharmacokinetics of Sertraline in Healthy Subjects: a Model-Based Meta-analysis	10
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	10
Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences that Impact Drug Pharmacokinetics	10
The Necessity of Using Changes in Absorption Time to Implicate Intestinal Transporter Involvement in Oral Drug-Drug Interactions	10
Subcutaneous Site-of-Absorption Study with the Monoclonal Antibody Tocilizumab in Minipigs: Administration Behind Ear Translates Best to Humans	10
The effects of all-trans retinoic acid on immune cells and its formulation design for vaccines	10
Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters	10
Immunogenicity Risk Assessment for Multi-specific Therapeutics	10
Microfluidic-Generated Immunomodulatory Nanoparticles and Formulation-Dependent Effects on Lipopolysaccharide-Induced Macrophage Inflammation	10
A Two-Pore Physiologically Based Pharmacokinetic Model to Predict Subcutaneously Administered Different-Size Antibody/Antibody Fragments	10
Quantitative Evaluation of the Effect of Antigen Expression Level on Antibody–Drug Conjugate Exposure in Solid Tumor	9
PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy	9
A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation	9
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	9
Role of HIV and Antiretroviral Therapy on the Expression of Placental Transporters in Women with HIV	9
Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine	9
Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics	9
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products	9
Structure-Based Design and Discovery of a Long-Acting Cocaine Hydrolase Mutant with Improved Binding Affinity to Neonatal Fc Receptor for Treatment of Cocaine Abuse	9
Iontophoresis to Overcome the Challenge of Nail Permeation: Considerations and Optimizations for Successful Ungual Drug Delivery	9
An Integrated Analysis of Dostarlimab Immunogenicity	9
Bioavailability Enhancement and Food Effect Elimination of Abiraterone Acetate by Encapsulation in Surfactant-Enriched Oil Marbles	9
Elucidating the Effect of Fine Lactose Ratio on the Rheological Properties and Aerodynamic Behavior of Dry Powder for Inhalation	9
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling	9
In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition	8
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends	8
Nano-delivery of Gemcitabine Derivative as a Therapeutic Strategy in a Desmoplastic KRAS Mutant Pancreatic Cancer	8
Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk	8
Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions	8
Evidence-Based Guidelines for Drug Interaction Studies: Model-Informed Time Course of Intestinal and Hepatic CYP3A4 Inhibition by Clarithromycin	8
A Systematic Approach for Liposome and Lipodisk Preclinical Formulation Development by Microfluidic Technology	8
A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products	7
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products	7
Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies	7
The Evolution of Single-Cell Analysis and Utility in Drug Development	7
Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties	7
Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group	7
Pitfalls in Predicting Hepatobiliary Drug Transport Using Human Sandwich-Cultured Hepatocytes	7
Metabolism of Speciociliatine, an Overlooked Kratom Alkaloid for its Potential Pharmacological Effects	7
Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein	7
Immunoglobulin G Is a Novel Substrate for the Endocytic Protein Megalin	7
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates	7
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations	7
Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry	7
Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey	7
Biliary Excretion–Mediated Food Effects and Prediction	7
Human Fetal Liver Metabolism of Oxycodone Is Mediated by CYP3A7	7
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	7
Recent Advances in 3D Printing for Parenteral Applications	6
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	6
Nfe2l2 Regulates Metabolic Rewiring and Epigenetic Reprogramming in Mediating Cancer Protective Effect by Fucoxanthin	6
High-Dose IV Administration of Rasburicase Suppresses Anti-rasburicase Antibodies, Depletes Rasburicase-Specific Lymphocytes, and Upregulates Treg Cells	6
Zwitterionic Polymer Coatings Enhance Gold Nanoparticle Stability and Uptake in Various Biological Environments	6
The Effects of Dose Volume and Excipient Dose on Luminal Concentration and Oral Drug Absorption	6
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow	6
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	6
Inter-compound and Intra-compound Global Sensitivity Analysis of a Physiological Model for Pulmonary Absorption of Inhaled Compounds	6
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	6
Estimation of Ontogeny Functions for Renal Transporters Using a Combined Population Pharmacokinetic and Physiology-Based Pharmacokinetic Approach: Application to OAT1,3	6
Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension	6
Simultaneous Ivabradine Parent-Metabolite PBPK/PD Modelling Using a Bayesian Estimation Method	6
Monoclonal Antibody Reagent Stability and Expiry Recommendation Combining Experimental Data with Mathematical Modeling	6
Direct Comparison of the Prediction of the Unbound Brain-to-Plasma Partitioning Utilizing Machine Learning Approach and Mechanistic Neuropharmacokinetic Model	6

Bioanalysis in the Age of New Drug Modalities	6
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D?	6
Reactive Oxygen Species–Responsive Celastrol-Loaded Bilirubin Nanoparticles for the Treatment of Rheumatoid Arthritis	6
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes	5
Correction to: Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Additional Benefit	5
Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions	5
Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products	5
Incorporating Breastfeeding-Related Variability with Physiologically Based Pharmacokinetic Modeling to Predict Infant Exposure to Maternal Medication Through Breast Milk: a Workflow Applied to Lamotri	5
The Nano-War Against Complement Proteins	5
Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy	5
Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration	5
Evaluation of Heat Effects on Transdermal Nicotine Delivery In Vitro and In Silico Using Heat-Enhanced Transport Model Analysis	5
Biomarker Assay Validation by Mass Spectrometry	5
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	5
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy	5
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	5
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations	5
Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs	5
Application of Model Informed Precision Dosing to Address the Impact of Pregnancy Stage and CYP2D6 Phenotype on Foetal Morphine Exposure	5
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium	5
Modulating Oral Delivery and Gastrointestinal Kinetics of Recombinant Proteins via Engineered Fungi	5
PBPK Simulation-Based Evaluation of Ganciclovir Crystalluria Risk Factors: Effect of Renal Impairment, Old Age, and Low Fluid Intake	5
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	5
Machine Learning Prediction of Clinical Trial Operational Efficiency	4
Efficacy and Safety Exposure–Response Analysis of Loncastuximab Tesirine in Patients with B cell non-Hodgkin Lymphoma	4
Pulmonary Delivery of Aerosolized Chloroquine and Hydroxychloroquine to Treat COVID-19: In Vitro Experimentation to Human Dosing Predictions	4
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials	4
Pulmonary administration of remdesivir in the treatment of COVID-19	4
Why Do the Majority of Submissions for Bridging from a Prefilled Syringe to an Autoinjector Include Bioequivalence Studies in Order to Demonstrate Comparability?	4
Association Between Vomiting and QT Hysteresis: Data from a TQT Study with the Endothelin A Receptor Antagonist Clazosentan	4
A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption	4
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	4
Lipid Nanoparticle-Enabled Intracellular Delivery of Prime Editors	4
Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody	4
Phish-Pharm: A Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish — 2022 Update	4
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	4
Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review	4
Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation	4
Predicting Food Effects: Are We There Yet?	4
Optimal Sampling Strategies for Irinotecan (CPT-11) and its Active Metabolite (SN-38) in Cancer Patients	4
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	4
Predicting Chemotherapy-Induced Neutropenia and Granulocyte Colony–Stimulating Factor Response Using Model-Based In Vitro to Clinical Translation	4
Multiscale and Translational Quantitative Systems Toxicology, Pharmacokinetic-Toxicodynamic Modeling Analysis for Assessment of Doxorubicin-Induced Cardiotoxicity	4
Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data	4
A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products	4
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS	4
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	4
Pancreatic Cancer: Recent Progress of Drugs in Clinical Trials	4
Comparison of Hepatic Transporter Tissue Expression in Rodents and Interspecies Hepatic OCT1 Activity	4
Cell-to-Medium Concentration Ratio Overshoot in the Uptake of Statins by Human Hepatocytes in Suspension, but Not in Monolayer: Kinetic Analysis Suggesting a Partial Loss of Functional OATP1Bs	4
Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays	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
Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics	4
Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease	4
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial	3
Pharmacokinetics of Monoclonal Antibody and Antibody Fragments in the Mouse Eye Following Systemic Administration	3
Developing Tools to Evaluate Non-linear Mixed Effect Models: 20 Years on the npde Adventure	3
Determinants of Biological Half-Lives and Terminal Slopes in Physiologically Based Pharmacokinetic Systems: Assessment of Limiting Conditions	3
Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data	3
Towards Evidence-Based Weaning: a Mechanism-Based Pharmacometric Model to Characterize Iatrogenic Withdrawal Syndrome in Critically Ill Children	3
Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir	3
Incorporating Pharmacological Target-Mediated Drug Disposition (TMDD) in a Whole-Body Physiologically Based Pharmacokinetic (PBPK) Model of Linagliptin in Rat and Scale-up to Human	3
Anti-drug Antibody Sample Testing and Reporting Harmonization	3
Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration	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
Flux-Based Formulation Development—A Proof of Concept Study	3
Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective	3
Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice	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
Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization	3
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	3
Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia	3
Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?	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
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	3
A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood	3
Nano/microparticle Formulations for Universal Influenza Vaccines	3
Science and Risked-Based Stability Testing Strategies—a Test Case on the Global Implementation and Regulatory Reception	3
New Model–Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling	3
AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived Antibodies	3
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence	3
Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)	3
Women in the Pharmaceutical Sciences: Honoring Our Pioneers	3