| no |
title |
author |
magazine |
year |
volume |
issue |
page(s) |
type |
| 1 |
A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption
|
Martinez, Marilyn N.
|
|
|
24 |
3 |
|
article
|
| 2 |
A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development
|
Martinez, Marilyn N.
|
|
|
24 |
3 |
|
article
|
| 3 |
A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer
|
Guelman, Sebastian
|
|
|
24 |
3 |
|
article
|
| 4 |
A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood
|
Hu, Teh-Min
|
|
|
24 |
3 |
|
article
|
| 5 |
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials
|
Dockendorf, Marissa F.
|
|
|
24 |
3 |
|
article
|
| 6 |
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat
|
Anderson, Melanie
|
|
|
24 |
3 |
|
article
|
| 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
|
Aburub, Aktham
|
|
|
24 |
3 |
|
article
|
| 8 |
Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System
|
Sharan, Satish
|
|
|
24 |
3 |
|
article
|
| 9 |
Biomarker Assay Validation by Mass Spectrometry
|
Fernández-Metzler, Carmen
|
|
|
24 |
3 |
|
article
|
| 10 |
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories
|
Hays, Amanda
|
|
|
24 |
3 |
|
article
|
| 11 |
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations
|
Abend, Andreas M.
|
|
|
24 |
3 |
|
article
|
| 12 |
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS
|
Hoffelder, Thomas
|
|
|
24 |
3 |
|
article
|
| 13 |
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence
|
Zou, Peng
|
|
|
24 |
3 |
|
article
|
| 14 |
Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration
|
Chang, Hsueh-Yuan
|
|
|
24 |
3 |
|
article
|
| 15 |
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines
|
Keire, David A.
|
|
|
24 |
3 |
|
article
|
| 16 |
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
|
Chu, Xiaoyan
|
|
|
24 |
3 |
|
article
|
| 17 |
Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
|
Hays, Amanda
|
|
|
24 |
3 |
|
article
|
| 18 |
Machine Learning Prediction of Clinical Trial Operational Efficiency
|
Wu, Kevin
|
|
|
24 |
3 |
|
article
|
| 19 |
Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties
|
Shah, Jaymin C.
|
|
|
24 |
3 |
|
article
|
| 20 |
Population Pharmacodynamic Modeling of Eflornithine-Based Treatments Against Late-Stage Gambiense Human African Trypanosomiasis and Efficacy Predictions of L-eflornithine-Based Therapy
|
Amilon, Carl
|
|
|
24 |
3 |
|
article
|
| 21 |
Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics
|
Yeoh, Thean
|
|
|
24 |
3 |
|
article
|
| 22 |
Targeted Delivery of Endosomal Escape Peptides to Enhance Immunotoxin Potency and Anti-cancer Efficacy
|
Polli, Joseph Ryan
|
|
|
24 |
3 |
|
article
|
| 23 |
The AAPS Journal Theme Issue: Rising Stars in Drug Delivery and Novel Carriers
|
Salem, Aliasger K.
|
|
|
24 |
3 |
|
article
|
| 24 |
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
|
Yoshida, Kenta
|
|
|
24 |
3 |
|
article
|
| 25 |
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform
|
Lotz, Gregor P.
|
|
|
24 |
3 |
|
article
|
Journal description