Terkko Navigator / The AAPS journal

Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay

Pharmacokinetics of Gentamicin Components C1, C1a, and C2/C2a/C2b and Subsequent Decline in Glomerular Filtration Rate in Neonates

Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy

Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures

Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review

Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates

Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters

Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy

Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study

Correction: Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration

When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform

A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood

Biomarker Assay Validation by Mass Spectrometry

Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?

Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration

A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer

A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption

Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System

A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development

Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence

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 IMpower150 Study

International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines

Machine Learning Prediction of Clinical Trial Operational Efficiency

Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories

DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS

An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat

A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials

The AAPS Journal Theme Issue: Rising Stars in Drug Delivery and Novel Carriers

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations

An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow

Population Pharmacodynamic Modeling of Eflornithine-Based Treatments Against Late-Stage Gambiense Human African Trypanosomiasis and Efficacy Predictions of L-eflornithine-Based Therapy

Targeted Delivery of Endosomal Escape Peptides to Enhance Immunotoxin Potency and Anti-cancer Efficacy

Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics

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

Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties

Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine

Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices

Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms

Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds

Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development

Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker

State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References

Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories

Application of Solubility and Dissolution Profile Comparison for Prediction of Gastric pH-Mediated Drug-Drug Interactions

Analytical Quality by Design, Life Cycle Management, and Method Control

Pulmonary Delivery of Aerosolized Chloroquine and Hydroxychloroquine to Treat COVID-19: In Vitro Experimentation to Human Dosing Predictions

Correction to: Reactive Oxygen Species–Responsive Celastrol-Loaded Bilirubin Nanoparticles for the Treatment of Rheumatoid Arthritis

The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution

Nfe2l2 Regulates Metabolic Rewiring and Epigenetic Reprogramming in Mediating Cancer Protective Effect by Fucoxanthin

Correction to: Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies