Articles

1. The Effects of Excipients on Freeze-dried Monoclonal Antibody Formulation Degradation and Sub-Visible Particle Formation during Shaking

   • Meng-Jia Jin
   • Xin-Zhe Ge
   • Wei-Jie Fang

   Original Research Article 30 January 2024 Pages: 321 - 334

   

2. Coupling Drug Dissolution with BCS

   • Antony Simitopoulos
   • Athanasios Tsekouras
   • Panos Macheras

   Original Research Article Open access 30 January 2024 Pages: 481 - 491

   

3. WANTED DEAD OR ALIVE: New Thinking to Incentivize Drug Development

   • Michael S. Kinch

   Perspective 30 January 2024 Pages: 199 - 202

   

4. Keratinocyte Exosomes for Topical Delivery of Tofacitinib in Treatment of Psoriasis: an In Vitro/ In Vivo Study in Animal Model of Psoriasis

   • Pouya Dehghani
   • Jaleh Varshosaz
   • Mahdi Bodaghi

   Original Research Article Open access 23 January 2024 Pages: 263 - 279

   

5. Correction: Comparative Study of Dermal Pharmacokinetics Between Topical Drugs Using Open Flow Microperfusion in a Pig Model

   • Manfred Bodenlenz
   • Thean Yeoh
   • Thomas Birngruber

   Correction Open access 19 January 2024 Pages: 409 - 409

6. Time-Lapse Macro Imaging with Dissolution Tests for Exploring the Interrelationship Between Disintegration and Dissolution Behaviors of Solid Dosages

   • Yichen Yang
   • Jiajia Gengji
   • Li Deng

   Original Research Article 19 January 2024 Pages: 387 - 400

   

7. Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes

   • Ziyun Xia
   • Minzhi Yu
   • Anna Schwendeman

   Original Research Article 11 January 2024 Pages: 293 - 303

   

8. IVIVC Revised

   • Nikolaos Alimpertis
   • Antony Simitopoulos
   • Panos Macheras

   Original Research Article 08 January 2024 Pages: 235 - 246

   

9. The Osmolality and Hemolysis of High-Concentration Monoclonal Antibody Formulations

   • Meng-Juan Pang
   • Meng-Wen Wang
   • Wei-Jie Fang

   Original Research Article 03 January 2024 Pages: 281 - 291

   

10. Correction: Effect of Buffer Salts on Physical Stability of Lyophilized and Spray-Dried Protein Formulations Containing Bovine Serum Albumin and Trehalose

    • Tarun Tejasvi Mutukuri
    • Jing Ling
    • Qi Tony Zhou

    Correction 29 December 2023 Pages: 405 - 406

    

11. Comparative Study of Dermal Pharmacokinetics Between Topical Drugs Using Open Flow Microperfusion in a Pig Model

    • Manfred Bodenlenz
    • Thean Yeoh
    • Thomas Birngruber

    Original Research Article Open access 29 December 2023 Pages: 223 - 234

    

12. Retraction Note: Dual Blockade of PD-1 and LAG3 Immune Checkpoints Increases Dendritic Cell Vaccine Mediated T Cell Responses in Breast Cancer Model

    • Asal Barshidi
    • Vahid Karpisheh
    • Farhad Jadidi-Niaragh

    Retraction Note 26 December 2023 Pages: 407 - 408

13. An In Silico Platform to Predict Cardiotoxicity Risk of Anti-tumor Drug Combination with hiPSC-CMs Based In Vitro Study

    • Lan Sang
    • Zhengying Zhou
    • Kun Hao

    Original Research Article Open access 26 December 2023 Pages: 247 - 262

    

14. Impact of Formulation and Microneedle Length on Transdermal Metronidazole Permeation through Microneedle-Treated Skin

    • Krishna Kumar Patel
    • Nicole K. Brogden

    Original Research Article 22 December 2023 Pages: 355 - 363

    

15. Editorial: Improving Product Quality through Process and Materials Understanding

    • Peter L. D. Wildfong
    • Rahul V. Haware
    • David A. Engers

    Preface 22 December 2023 Pages: 2759 - 2760

16. 2022 and 2023 Reviewer Thanks

    ACKNOWLEDGEMENT 20 December 2023 Pages: 401 - 403

17. Application of PAT Probes in Aluminum Phosphate Adjuvant Manufacturing

    • Przemyslaw Kowal
    • Ginny Fung
    • Marina Kirkitadze

    Original Research Article 19 December 2023 Pages: 375 - 385

    

18. Exploiting Apical Sodium-Dependent Bile Acid Transporter (ASBT)-Mediated Endocytosis with Multi-Functional Deoxycholic Acid Grafted Alginate Amide Nanoparticles as an Oral Insulin Delivery System

    • Maryam Razmjooei
    • Seyed Mohammad Hashem Hosseini
    • Mohammad Hadi Eskandari

    Original Research Article 19 December 2023 Pages: 335 - 353

    

19. PBPK/PD Modeling of Nifedipine for Precision Medicine in Pregnant Women: Enhancing Clinical Decision-Making for Optimal Drug Therapy

    • Xinyang Liu
    • Wei Wang
    • Defang Ouyang

    Original Research Article 04 December 2023 Pages: 63 - 75

    

20. Impact of Processing Methods on the Physico-chemical Properties of Posaconazole Amorphous Solid Dispersions

    • Ru He
    • Matthew S. Lamm
    • Yongjun Li

    Original Research Article 01 December 2023 Pages: 141 - 151

    

21. Professor David E. Smith: A Fearless Scientist and Devoted Mentor

    • Brian Thompson
    • Kim Brouwer
    • Maria M. Posada

    EditorialNotes 29 November 2023 Pages: 2493 - 2497

    

22. General Commentary: A Tribute to Professor Kenneth R. Morris – Scientist, Teacher, Mentor, Friend…and Underappreciated Academic Arborist

    • Peter L. D. Wildfong

    Tribute 28 November 2023 Pages: 2761 - 2767

    

23. Comparative Study of Sorption Phenomena Between Three Medications and Syringes Made of Cyclic Olefin Copolymer or Polypropylene

    • Joëlle Claves
    • Philip Chennell
    • Valérie Sautou

    Original Research Article 21 November 2023 Pages: 51 - 62

    

24. AgNPs-Modified Polylactic Acid Microneedles: Preparation and In Vivo/In Vitro Antimicrobial Studies

    • Wenqin Zhang
    • Xiaozhen Cai
    • Jianmin Chen

    Original Research Article 20 November 2023 Pages: 93 - 104

    

25. Elucidating the Impact of Material Properties on Tablet Manufacturability for Binary Paracetamol Blends

    • Lena Mareczek
    • Carolin Riehl
    • Stephan Reichl

    Original Research Article 17 November 2023 Pages: 185 - 197

    

26. Development of Sustained Release System Based on High Water-Absorbable Gel Formation Using Croscarmellose Sodium, Alkaline Excipients and HPMC (ACSH SR System); Novel Application of Croscarmellose Sodium as a Gel Former

    • Masato Gomi
    • Naoya Mizutani
    • Kazutaka Higaki

    Original Research Article 14 November 2023 Pages: 3073 - 3086

    

27. LC–MS Approach to Decipher a Light Chain Chromatographic Peak Splitting of a Monoclonal Antibody

    • Yanjun Liu
    • Zac VanAernum
    • Jennifer S. Chadwick

    Original Research Article 07 November 2023 Pages: 3087 - 3098

    

28. Use of Resonant Acoustic Mixing Technology for Ultra-Low-Dose Blending in a Single-Step Mixing Process

    • Kyle A. Frey
    • Helen Baker
    • David A. Engers

    Original Research Article 07 November 2023 Pages: 165 - 183

    

29. Fabrication and Characterization of Dissolving Microneedles for Transdermal Drug Delivery of Apomorphine Hydrochloride in Parkinson’s Disease

    • Daisuke Ando
    • Aisa Ozawa
    • Ken-ichi Izutsu

    Original Research Article 03 November 2023 Pages: 153 - 163

    

30. Pharmaceutical and Immunological Evaluation of Cholera Toxin A1 Subunit as an Adjuvant of Hepatitis B Vaccine Microneedles

    • Jong-Chan Kim
    • Jung-ah Choi
    • Jung-Hwan Park

    Original Research Article 01 November 2023 Pages: 3059 - 3071

    

31. A Stable Irinotecan Liposome with Enhanced Antitumor Activity in a Range of Tumor Models

    • Zhengxing Su
    • Li Li
    • Dong Zhao

    Original Research Article 01 November 2023 Pages: 3043 - 3058

    

32. Integrated Exposure–Response of Dupilumab in Children, Adolescents, and Adults With Atopic Dermatitis Using Categorical and Continuous Efficacy Assessments: A Population Analysis

    • Emily Briggs
    • Mohamed A. Kamal
    • Nidal Huniti

    Original Research Article Open access 11 December 2023 Pages: 2653 - 2666

    

33. Benchmark Glycan Profile of Therapeutic Monoclonal Antibodies Produced by Mammalian Cell Expression Systems

    • Shen Luo
    • Baolin Zhang

    Original Research Article Open access 01 November 2023 Pages: 29 - 37

    

34. A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment

    • Zhe Li
    • Xiulian Du
    • Yow-Ming C. Wang

    Original Research Article 01 November 2023 Pages: 13 - 27

    

35. Effect of Food Viscosity on Drug Dissolution

    • Rika Hirose
    • Kiyohiko Sugano

    Original Research Article 26 October 2023 Pages: 105 - 112

    

36. Validation of Anti-Adeno Associated Virus Serotype rh10 (AAVrh.10) Total and Neutralizing Antibody Immunogenicity Assays

    • Elizabeth Butala-Flores
    • Thien Nguyen
    • Amanda Hays

    Original Research Article Open access 25 October 2023 Pages: 2383 - 2397

    

37. Examination of the Rate and Extent of Drug Released from Commercial Topical Delivery Systems During Wear: An Example with Lidocaine Topical Systems

    • Qing Cai
    • Armita Azarpanah
    • Nicole K. Brogden

    Original Research Article 17 October 2023 Pages: 39 - 50

    

38. Discovery of the Next Generation of Non-peptidomimetic Neurolysin Activators with High Blood-Brain Barrier Permeability: a Pharmacokinetics Study in Healthy and Stroke Animals

    • Yong Zhang
    • Sejal Sharma
    • Thomas J. Abbruscato

    Original Research Article 13 October 2023 Pages: 2747 - 2758

    

39. Hydration Mechanism and Its Effect on the Solubility of Aripiprazole

    • Zhixin Zheng
    • Xin Huang
    • Hongxun Hao

    Original Research Article 13 October 2023 Pages: 113 - 127

    

40. Mechanistic Static Model based Prediction of Transporter Substrate Drug-Drug Interactions Utilizing Atorvastatin and Rifampicin

    • Pallabi Mitra
    • Rumanah Kasliwala
    • Mitchell E. Taub

    Original Research Article 11 October 2023 Pages: 3025 - 3042

    

41. Cortisol as Biomarker for CYP17-Inhibition is Associated with Therapy Outcome of Abiraterone Acetate

    • Maaike A. C. Bruin
    • Ma Ida Mohmaed Ali
    • Alwin D. R. Huitema

    Original Research Article 11 October 2023 Pages: 3001 - 3010

    

42. A Minimal PBPK Model for Plasma and Cerebrospinal Fluid Pharmacokinetics of Trastuzumab after Intracerebroventricular Administration in Patients with HER2-Positive Brain Metastatic Localizations

    • Alicja Puszkiel
    • Guilhem Bousquet
    • Xavier Declèves

    Original Research Article 11 October 2023 Pages: 2687 - 2697

    

43. Mitigation of Tribocharging in Pharmaceutical Powders using Surface Modified V-Blenders

    • Tanu Mehta
    • Raj Mukherjee
    • Bodhisattwa Chaudhuri

    Original Research Article 11 October 2023 Pages: 2371 - 2381

    

44. Industry Perspective – What does Industry Need to Accelerate Drug Product and Process Development?

    • Bikash Chatterjee
    • Richard Steiner
    • Goldi Kaul

    Perspective Open access 11 October 2023 Pages: 7 - 11

    

45. Assessing Dose-Exposure–Response Relationships of Miltefosine in Adults and Children using Physiologically-Based Pharmacokinetic Modeling Approach

    • Shadrack J. Madu
    • Ke Wang
    • Mingzhong Li

    Original Research Article Open access 10 October 2023 Pages: 2983 - 3000

    

46. Preclinical Pharmacokinetics and Translational Pharmacokinetic/Pharmacodynamic Modeling of M8891, a Potent and Reversible Inhibitor of Methionine Aminopeptidase 2

    • Floriane Lignet
    • Manja Friese-Hamim
    • Felix Rohdich

    Original Research Article Open access 05 October 2023 Pages: 3011 - 3023

    

47. Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies

    • Victor A. Beaumont
    • Lucy Liu
    • Hai-Young Kim

    Original Research Article Open access 05 October 2023 Pages: 2457 - 2467

    

48. Development and Validation of Discriminatory In-vitro Release Method for Intramammary Drug Product

    • Nada A. Helal
    • Marilyn N. Martinez
    • Mohammad T. H. Nutan

    Original Research Article 03 October 2023 Pages: 129 - 139

    

49. Physiological Dynamics in the Upper Gastrointestinal Tract and the Development of Gastrointestinal Absorption Models for the Immediate-Release Oral Dosage Forms in Healthy Adult Human

    • Kai Wang
    • Gordon L. Amidon
    • David E. Smith

    Review Article 03 October 2023 Pages: 2607 - 2626

    

50. Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update

    • Serguei Tchessalov
    • Vito Maglio
    • Evgenyi Shalaev

    Original Research Article Open access 02 October 2023 Pages: 2433 - 2455