1. Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies

   • Shravan Sreenivasan
   • Anurag S. Rathore

   Research Article 14 February 2024 Article: 25

   

2. Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development

   • Amanda Hays
   • Mark Wissel
   • Oskar Johansson

   White Paper Open access 05 February 2024 Article: 24

   

3. Agreement Between a Colorimetric Assay and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Quantifying Paracetamol Plasma Concentrations

   • Angela Elma Edwina
   • Erwin Dreesen
   • Jos Tournoy

   Research Article 01 February 2024 Article: 23

   

4. An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing

   • Hirokazu Wakuda
   • Yue Xiang
   • Leslie Z. Benet

   Research Article Open access 30 January 2024 Article: 22

   

5. Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models

   • Leticia Arrington
   • Mats O. Karlsson

   Research Article Open access 25 January 2024 Article: 21

   

6. Connexin-Containing Vesicles for Drug Delivery

   • Mahmoud S. Hanafy
   • Zhengrong Cui

   Review Article 24 January 2024 Article: 20

   

7. Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products

   • Fang Wu
   • Youssef Mousa
   • Liang Zhao

   Review Article 24 January 2024 Article: 19

   

8. Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay

   • Veronica Liu
   • Kelly McGrath
   • Yong Jiang

   Research Article 24 January 2024 Article: 18

   

9. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model

   • Anas Saadeddin
   • Vivek Purohit
   • Kazuko Sagawa

   Research Article Open access 24 January 2024 Article: 17

   

10. Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies

    • Audrey Arjomandi
    • Ketevan Siradze
    • Saloumeh K. Fischer

    Research Article 24 January 2024 Article: 16

    

11. Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development

    • Yuqing Gong
    • Francis-Xavier Barretto
    • Liang Zhao

    Meeting Report 24 January 2024 Article: 15

    

12. Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report

    • Eleftheria Tsakalozou
    • Lanyan Fang
    • Liang Zhao

    Meeting Report 10 January 2024 Article: 14

    

13. Building a Predictive PBPK Model for Human OATP Substrates: a Strategic Framework for Early Evaluation of Clinical Pharmacokinetic Variations Using Pitavastatin as an Example

    • Xiaomin Liang
    • Megan L. Koleske
    • Yurong Lai

    Research Article 05 January 2024 Article: 13

    

14. Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

    • Ross L. Walenga
    • Andrew H. Babiskin
    • Partha Roy

    Meeting Report 04 January 2024 Article: 12

    

15. A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK

    • Ran Li
    • Edward Dere
    • Meric A. Ovacik

    Research Article Open access 02 January 2024 Article: 11

    

16. Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape

    • Satish G. Jadhav
    • Ryan L. Setten
    • Steven F. Dowdy

    Brief/Technical Note 22 December 2023 Article: 10

    

17. 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

    • Maoyin Li
    • Audrey Arjomandi
    • Keyang Xu

    Research Article Open access 19 December 2023 Article: 9

    

18. Notes on the Use of Kirchhoff’s Laws in Pharmacokinetics

    • Ronald A. Siegel

    Commentary 19 December 2023 Article: 8

    

19. Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19

    • Michelle Stafford
    • Rachel Linck Dunn
    • Alex Viehmann

    Research Article 19 December 2023 Article: 7

    

20. Correction to: Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics

    • Kirk Haltaufderhyde
    • Brian J. Roberts
    • Anne S. De Groot

    Correction Open access 19 December 2023 Article: 6

21. Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing

    • Ankur Sharma
    • Xin Liu
    • Sukyung Woo

    Research Article Open access 12 December 2023 Article: 5

    

22. A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia

    • Wojciech Krzyzanski
    • Pia Wintermark
    • Karel Allegaert

    Research Article Open access 05 December 2023 Article: 4

    

23. Therapeutic Fusion Proteins

    • Morgan C. Marsh
    • Shawn C. Owen

    Review Article-theme 30 November 2023 Article: 3

    

24. Correction: A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications

    • Shiny Amala Priya Rajan
    • Jason Sherfey
    • Murat Cirit

    Correction Open access 20 November 2023 Article: 2

25. Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development

    • Hester Kramer
    • Ceyhun Bicer
    • Hugues Chanteux

    Research Article Open access 16 November 2023 Article: 1