Advancing Pharmaceutical Security: Noninvasive Detection of Falsified Vaccines and Drugs Using wNMR Marc B. TarabanKatharine T. BriggsY. Bruce Yu Original Research Article 13 June 2025
Controlling Gastric Delivery of a GIP/GLP1 Peptide in Monkeys by Mucoadhesive SNAC Tablets Huyen TranJennifer MartinAktham Aburub Original Research Article 13 June 2025
Sialic Acid-based Glycoconjugation on Myricetin-encapsulated Cationic Nanocarriers for the Treatment of Alzheimer's Tripti HalderNiyati Acharya Original Research Article 09 June 2025
Impact of Initial Aggregate Level on Aggregation Potential of Monoclonal Antibodies in Different Buffer Systems Anuj ShrivastavaAnurag S. Rathore Original Research Article 06 June 2025
Modification of Peptide and Permeation Enhancer In Vitro Release Rates by Dispersion with a Gel-Forming Polymer Pradnya BapatSheena Lee LuyLynne S. Taylor Original Research Article Open access 06 June 2025
The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology Panos MacherasAthanasios A. TsekourasKosmas Kosmidis Review Article Open access 05 June 2025
Liposomal Vardenafil and Linagliptin Combined with Irinotecan for Synergistic Colorectal Cancer Therapy Xian ZhaoRuijie XuPei Zhang Original Research Article 05 June 2025
PEGylation of Propofol Reduces Its Adsorption to Extracorporeal Membrane Oxygenator (ECMO) Components Benedetta CamparaNitish KhuranaHamidreza Ghandehari Next Generation of Drug Delivery Strategies Theme Issue 05 June 2025
Development of Alogliptin Oral-Dissolving Films with Optimized Therapeutic Outcomes Sagar PathadeVarsha Balkrishna ManeRushikesh Kshirsagar Original Research Article 04 June 2025
Decrease in In Vivo Efflux Transport via P-glycoprotein at the Rat Inner Blood-Retinal Barrier by Peripheral Administration of Lipopolysaccharide Kiyotaka DaikoharaShin-ichi AkanumaKen-ichi Hosoya Original Research Article 03 June 2025
Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions Yi-Hsien ChengArindom PalFang Wu FDA Model Master File 29 May 2025 Pages: 753 - 763
The Innovation Paradox in Emerging Pharmaceutical Markets: Barriers and Opportunities for Sustainable Development Frederico Severino MartinsSivacharan KolliparaEliana Souto NIPTE Special Theme Issue 29 May 2025
Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches Lanyan FangEleftheria TsakalozouJames E. Polli FDA Model Master File 28 May 2025 Pages: 727 - 729
Assessment of the Effects of Ionizing Radiation on Biologic Drugs: mAb Product Quality and Risk Evaluation for Global Shipping Logistics Nathalie FuentesArjun SuriStanley C. Kwok Original Research Article Open access 16 May 2025
Hispidulin Isolated from the Leaves of Clerodendrum inerme (L.) Gaertn Suppresses Trigeminovascular System Activation in a Rat Model Mimicking Migraine Pi-Chuan FanMing Tatt LeeLih-Chu Chiou Natural Products from Drug Discovery to Clinical Trials Theme Issue 09 May 2025
Preclinical Toxicity Study and Tissue Distribution of YSCH- 01 Injection via Intratumoral Injection, Intravenous Injection, and Intraperitoneal Injection in Syrian Hamsters Ruoyu ChenXian-Long FangHafiz Khuram Raza Original Research Article 08 May 2025
Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling Arindom PalKhondoker AlamFang Wu FDA Model Master File 04 June 2025 Pages: 835 - 845
Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use Lanyan FangEleftheria TsakalozouRobert Lionberger FDA Model Master File 03 June 2025 Pages: 731 - 735
An In Vitro Dissolution Method for Inhaled Drugs Depositing in the Tracheobronchial Lung Region Alexander HuangScott TaverniniAndrew R. Martin Original Research Article 28 April 2025 Pages: 639 - 650
Correction: A Preformulation Experiment: The Influence of Poloxamer 188 and Poloxamer 407 on the Binding Coefficients (Single Molecule) and the Partitioning Coefficients (Micelle) of Ketoprofen (Probe Molecule) with Sodium Cholate, Dodecyl Trimethylammonium Bromide and BrijC10 Surfactants Zita Farkaš AgatićVesna TepavčevićMihalj Poša Correction 23 April 2025 Pages: 725 - 725
Nitrosamine Drug Substance-Related Impurities (NDSRIs) in Pharmaceuticals: Formation, Mitigation Strategies, and Emphasis on Mutagenicity Risks Dande AishwaryaVaishnavi Ramakant DhampalwarRamalingam Peraman Review Article 23 April 2025 Pages: 547 - 578
Predicting Powder Blend Flowability from Individual Constituent Properties Using Machine Learning Anna OwasitSiddharth TripathiJoshua Young Original Research Article Open access 17 April 2025 Pages: 665 - 683
Learning Chemotherapy Drug Action via Universal Physics-Informed Neural Networks Lena PodinaAli GhodsiMohammad Kohandel Original Research Article 17 April 2025 Pages: 593 - 612
Evaluation of Process Parameters for Continuous Manufacturing of Quetiapine Fumarate Immediate Release Tablets Using Twin Screw Wet Granulation Tejaswini NaguboyinaPreethi LakkalaMichael Repka Original Research Article Open access 14 April 2025 Pages: 685 - 696
A Preformulation Experiment: The Influence of Poloxamer 188 and Poloxamer 407 on the Binding Coefficients (Single Molecule) and the Partitioning Coefficients (Micelle) of Ketoprofen (Probe Molecule) with Sodium Cholate, Dodecyl Trimethylammonium Bromide and BrijC10 Surfactants Zita Farkaš AgatićVesna TepavčevićMihalj Poša Original Research Article 04 April 2025 Pages: 711 - 724
Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio Yuki TarumiYuji HigashiguchiKiyohiko Sugano Original Research Article Open access 04 April 2025 Pages: 623 - 637
Combining High-Throughput Screening and Machine Learning to Predict the Formation of Both Binary and Ternary Amorphous Solid Dispersion Formulations for Early Drug Discovery and Development Tianshu LuYiyang WuDefang Ouyang Original Research Article 03 April 2025 Pages: 697 - 709
Characterizing the Influence of Relative Humidity and Ethanol Content on the Dynamic Size Distributions of Aerosols Generated from a Soft Mist Inhaler Yiliang Lance JiangJose R. RuizJonathan P. Reid Original Research Article Open access 01 April 2025 Pages: 651 - 663
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization Yi-Hsien ChengSherin ThomasFang Wu FDA Model Master File Open access 28 March 2025 Pages: 819 - 833
PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations Fang WuEleftheria TsakalozouLanyan Fang FDA Model Master File Open access 26 March 2025 Pages: 847 - 855
Predicting Distribution Coefficients (LogD) of Cyclic Peptides Using Molecular Dynamics Simulations Hao LouMei FengMichael J. Hageman Original Research Article 26 March 2025 Pages: 613 - 622
GraphDeep-hERG: Graph Neural Network PharmacoAnalytics for Assessing hERG-Related Cardiotoxicity Yankang JingYiyang ZhangXiang-Qun Xie Original Research Article 26 March 2025 Pages: 579 - 591
Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches Anne S. De GrootAimee MatteiGuilhem Richard FDA Model Master File Open access 24 March 2025 Pages: 805 - 818
Enhanced Penetration and Retention of an Antibody in the Articular Cartilage Through Aggrecan Binding and Molecular Downsizing Yuki NoguchiMaiko HoshinoTomoyuki Igawa Original Research Article 17 March 2025 Pages: 503 - 510
Editorial Expression of Concern: Nano-Targeted Delivery of Toremifene, an Estrogen Receptor-α Blocker in Prostate Cancer Waseem HaririThangirala SudhaShaker A. Mousa Editorial Expression of Concern 14 March 2025 Pages: 545 - 545
Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook Sivacharan KolliparaMarkus FridenTimothy Nicholas FDA Model Master File 12 March 2025 Pages: 785 - 794
In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets Ana L. CoutinhoAsmita AdhikariJames E. Polli Original Research Article Open access 11 March 2025 Pages: 485 - 502
Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report Eleftheria TsakalozouLanyan FangLiang Zhao FDA Model Master File Open access 07 March 2025 Pages: 737 - 746
Development of a Melting Point Depression Method to Measure the Solubility of a Small-Molecule Drug in Poly-Lactic-co-Glycolic Acid (PLGA) Coleman JohnsonFeng Zhang Original Research Article 06 March 2025 Pages: 529 - 543
Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development Jiang LiuYuching YangHao Zhu FDA Model Master File Open access 04 March 2025 Pages: 765 - 771
Clinical Evaluation of the Temperature Dependence of Subcutaneous Injection Experience in Healthy Volunteers Galen ShiHannie ShihDavid Collins Original Research Article 03 March 2025 Pages: 475 - 484
Phytochemicals and their Nanoformulations for Overcoming Drug Resistance in Head and Neck Squamous Cell Carcinoma Zhai PingpingChen NanTang Yong Natural Products from Drug Discovery to Clinical Trials Theme Issue 03 March 2025 Pages: 429 - 449
Synthesis and Biological Evaluation of Novel Triazine Analogs as Rad6 Inhibitors Qian LinAmbikai GajanMalathy P. Shekhar Original Research Article 28 February 2025 Pages: 511 - 527
Population Pharmacokinetics of IV Lidocaine and its Metabolites in Adult Surgical Patients Keng Wah FoongPui San LohYoke Lin Lo Original Research Article 28 February 2025 Pages: 451 - 473
Leveraging Model Master Files from a Technology Company Perspective: Facilitating Quantitative Medicine in Regulatory Frameworks Jan De BackerJames ClarkeJessica Spires FDA Model Master File 26 February 2025 Pages: 795 - 803
Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products Ross L. WalengaKhondoker AlamEleftheria Tsakalozou FDA Model Master File Open access 26 February 2025 Pages: 773 - 784
Combined Treatment of Metformin and Resveratrol Promotes Myogenesis Through Increased Irisin Release in C2C12 Cells Eun Ji SeongYejin KimJong Hun Lee Natural Products from Drug Discovery to Clinical Trials Theme Issue 26 February 2025 Pages: 419 - 428
Advanced Manufacturing, Modeling And Analytical Tools In Injectable Products Howard StamatoMaxwell Korang-YeboahRobin Bogner NIPTE Special Theme Issue 26 February 2025 Pages: 413 - 418
In vitro Stability Study of a Panel of Commercial Antibodies at Physiological pH and Temperature as a Guide to Screen Biologic Candidate Molecules for the Potential Risk of In vivo Asparagine Deamidation and Activity Loss Richa GargSean McCarthyRajeeva Singh Original Research Article Open access 20 February 2025 Pages: 353 - 363
Structure Bioinformatics of Six Human Integral Transmembrane Enzymes and their AlphaFold3 Predicted Water-Soluble QTY Analogs: Insights into FACE1 and STEA4 Binding Mechanisms Edward ChenEmily PanShuguang Zhang Original Research Article Open access 18 February 2025 Pages: 291 - 305
