Articles

1. Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability

   • Shuhui Li
   • Kairui Feng
   • Jogarao V. S. Gobburu

   Research Article 26 April 2024 Article: 56

   

2. Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023

   • Eleftheria Tsakalozou
   • Yuqing Gong
   • Liang Zhao

   Editorial 24 April 2024 Article: 55

3. Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling

   • Xavier J. H. Pepin
   • Sandra Suarez-Sharp

   Research Article 24 April 2024 Article: 54

   

4. Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity

   • Gourav Paudwal
   • Rigzin Dolkar
   • Prem N. Gupta

   Research Article 22 April 2024 Article: 52

   

5. Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method

   • Rosanna S. Kwok
   • Ihsan Nijem
   • Robert Hendricks

   Research Article Open access 18 April 2024 Article: 51

   

6. Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies

   • Helmut Schütz
   • Divan A. Burger
   • Michael Tomashevskiy

   Research Article Open access 17 April 2024 Article: 50

   

7. Recent Advances in Drug Delivery

   • Aliasger K. Salem

   Editorial 15 April 2024 Article: 49

8. Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations

   • Masaru Kato
   • Shinichi Maruyama
   • Hiroshi Kanno

   Research Article 15 April 2024 Article: 48

   

9. Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m⁶A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway

   • Rong Liu
   • Qiang Wang
   • Jiafei Lu

   Research Article 15 April 2024 Article: 47

   

10. Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine

    • Elizabeth Oladoyin Agboluaje
    • Shuolin Cui
    • May P. Xiong

    Research Article 12 April 2024 Article: 46

    

11. Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

    • Arindom Pal
    • Fang Wu
    • Lanyan Fang

    Meeting Report 08 April 2024 Article: 45

    

12. Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling

    • Venkata Krishna Kowthavarapu
    • Nitin Bharat Charbe
    • Rodrigo Cristofoletti

    Tutorial 04 April 2024 Article: 44

    

13. Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing

    • Selina Wilson
    • Julianne Farabaugh
    • Karen Thompson

    Commentary 04 April 2024 Article: 43

    

14. LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics

    • Himanshu Malani
    • Anuj Shrivastava
    • Anurag S. Rathore

    Research Article 03 April 2024 Article: 42

    

15. Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety

    • Kimberly K. Ballman
    • Victoria L. Peek
    • Yi Wen

    Research Article 03 April 2024 Article: 41

    

16. Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature on ¹H T₁ Relaxation Times

    • Ashley Lay-Fortenbery
    • Cole W. Tower
    • Eric J. Munson

    Research Article Open access 03 April 2024 Article: 40

    

17. PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications

    • Lu Chen
    • Erin Dombrowsky
    • Neelima Thanneer

    Tutorial Open access 03 April 2024 Article: 39

    

18. Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery

    • Sam Zhang
    • Christine C. Orozco
    • Li Di

    Research Article 28 March 2024 Article: 38

    

19. Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate

    • Weifeng Xu
    • Nazneen Bano
    • Roy Helmy

    Research Article 28 March 2024 Article: 37

    

20. Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes

    • Jianhua Liu
    • Daria Vernikovskaya
    • Li Di

    Research Article 28 March 2024 Article: 36

    

21. State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies

    • Joshua Yu
    • Nirnoy Dan
    • Xiuling Lu

    Review Article-theme 21 March 2024 Article: 35

    

22. Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes

    • Lori McCaig
    • Steven Nowak
    • Lars Gruenig

    Commentary 14 March 2024 Article: 34

    

23. Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution

    • Eugenia Opolka-Hoffmann
    • Martin R. Edelmann
    • Roland F. Staack

    Research Article Open access 13 March 2024 Article: 33

    

24. Quality by Design Framework Applied to GMMA Purification

    • Carlo Giannelli
    • Francesca Necchi
    • Francesca Micoli

    Research Article Open access 08 March 2024 Article: 32

    

25. Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework

    • Jason H. Williams
    • Kai H. Liao
    • Xu Meng

    Research Article Open access 07 March 2024 Article: 31

    

26. A Short Update on the Use of Monoclonal Antibodies in COVID-19

    • Antonio Vitiello
    • Michela Sabbatucci
    • Andrea Zovi

    Brief/Technical Note 05 March 2024 Article: 30

27. Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data

    • Shengjia Wu
    • Hsueh-Yuan Chang
    • Dhaval K. Shah

    Research Article 05 March 2024 Article: 29

    

28. The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

    • Lanyan Fang
    • Yuqing Gong
    • Liang Zhao

    Meeting Report 27 February 2024 Article: 28

    

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

    • Anas Saadeddin
    • Vivek Purohit
    • Kazuko Sagawa

    Correction Open access 21 February 2024 Article: 27

30. Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates

    • Jie Chen
    • Lloyd Wei Tat Tang
    • Li Di

    Research Article 16 February 2024 Article: 26

    

31. 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

    

32. 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

    

33. 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

    

34. 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

    

35. 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

    

36. Connexin-Containing Vesicles for Drug Delivery

    • Mahmoud S. Hanafy
    • Zhengrong Cui

    Review Article 24 January 2024 Article: 20

    

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

    • Fang Wu
    • Youssef Mousa
    • Liang Zhao

    Review Article 24 January 2024 Article: 19

    

38. 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

    

39. 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

    

40. 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

    

41. 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

    

42. 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

    

43. 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

    

44. 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

    

45. 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

    

46. 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

    

47. 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

    

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

    • Ronald A. Siegel

    Commentary 19 December 2023 Article: 8

    

49. 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

    

50. 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