Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs Rudiger KasperaYoshihisa Shitara Review Article 17 June 2024 Article: 71
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues? Diletta BerardinelliOmayema TaoussiJeremy Carlier Research Article Open access 11 June 2024 Article: 70
Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space Michael WangTycho HeimbachFilippos Kesisoglou Research Article 11 June 2024 Article: 69
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents Anna KoppJiakun GuanGreg M. Thurber Research Article 11 June 2024 Article: 68
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver Hari Prasath NagaiahPriya Dharsini Periyakaruppan MurugesanKarutha Pandian Shunmugiah Research Article 11 June 2024 Article: 67
Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges? Sivacharan KolliparaMahendra ChouguleTausif Ahmed Review Article 11 June 2024 Article: 66
Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach John P. PrybylskiYuchen WangVivek Purohit Research Article Open access 06 June 2024 Article: 65
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm Mélanie GuhlJulie BertrandEmmanuelle Comets Correction 06 June 2024 Article: 64
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine Innocent Gerald AsiimweBonginkosi S’fiso NdzambaJennifer Lang Research Article Open access 30 May 2024 Article: 63
Correction: Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS) Niels HendrickxFrance MentréEmmanuelle Comets Correction Open access 24 May 2024 Article: 62
Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands Léa SorretWei Han TanMatthias Winzer Research Article 15 May 2024 Article: 61
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route Jacob FeldermanLila RamaiahYing Chen Research Article 10 May 2024 Article: 60
Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables? Tan ZhangElisa A. M. CalvierCatherijne A. J. Knibbe Research Article Open access 09 May 2024 Article: 59
Correction: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies Helmut SchützDivan A. BurgerMichael Tomashevskiy Correction Open access 06 May 2024 Article: 58
Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS) Niels HendrickxFrance MentréEmmanuelle Comets Research Article Open access 30 April 2024 Article: 57
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability Shuhui LiKairui FengJogarao V. S. Gobburu Research Article 26 April 2024 Article: 56
Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023 Eleftheria TsakalozouYuqing GongLiang Zhao Editorial 24 April 2024 Article: 55
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling Xavier J. H. PepinSandra Suarez-Sharp Research Article 24 April 2024 Article: 54
Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm Mélanie GuhlJulie BertrandEmmanuelle Comets Research Article 23 April 2024 Article: 53
Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity Gourav PaudwalRigzin DolkarPrem N. Gupta Research Article 22 April 2024 Article: 52
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method Rosanna S. KwokIhsan NijemRobert Hendricks Research Article Open access 18 April 2024 Article: 51
Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies Helmut SchützDivan A. BurgerMichael Tomashevskiy Research Article Open access 17 April 2024 Article: 50
Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations Masaru KatoShinichi MaruyamaHiroshi Kanno Research Article 15 April 2024 Article: 48
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 LiuQiang WangJiafei Lu Research Article 15 April 2024 Article: 47
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine Elizabeth Oladoyin AgboluajeShuolin CuiMay P. Xiong Research Article 12 April 2024 Article: 46
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 PalFang WuLanyan Fang Meeting Report 08 April 2024 Article: 45
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 KowthavarapuNitin Bharat CharbeRodrigo Cristofoletti Tutorial 04 April 2024 Article: 44
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing Selina WilsonJulianne FarabaughKaren Thompson Commentary 04 April 2024 Article: 43
LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics Himanshu MalaniAnuj ShrivastavaAnurag S. Rathore Research Article 03 April 2024 Article: 42
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety Kimberly K. BallmanVictoria L. PeekYi Wen Research Article 03 April 2024 Article: 41
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-FortenberyCole W. TowerEric J. Munson Research Article Open access 03 April 2024 Article: 40
PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications Lu ChenErin DombrowskyNeelima Thanneer Tutorial Open access 03 April 2024 Article: 39
Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery Sam ZhangChristine C. OrozcoLi Di Research Article 28 March 2024 Article: 38
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate Weifeng XuNazneen BanoRoy Helmy Research Article 28 March 2024 Article: 37
Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes Jianhua LiuDaria VernikovskayaLi Di Research Article 28 March 2024 Article: 36
State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies Joshua YuNirnoy DanXiuling Lu Review Article-theme 21 March 2024 Article: 35
Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes Lori McCaigSteven NowakLars Gruenig Commentary 14 March 2024 Article: 34
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution Eugenia Opolka-HoffmannMartin R. EdelmannRoland F. Staack Research Article Open access 13 March 2024 Article: 33
Quality by Design Framework Applied to GMMA Purification Carlo GiannelliFrancesca NecchiFrancesca Micoli Research Article Open access 08 March 2024 Article: 32
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework Jason H. WilliamsKai H. LiaoXu Meng Research Article Open access 07 March 2024 Article: 31
A Short Update on the Use of Monoclonal Antibodies in COVID-19 Antonio VitielloMichela SabbatucciAndrea Zovi Brief/Technical Note 05 March 2024 Article: 30
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data Shengjia WuHsueh-Yuan ChangDhaval K. Shah Research Article 05 March 2024 Article: 29
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA Lanyan FangYuqing GongLiang Zhao Meeting Report 27 February 2024 Article: 28
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model Anas SaadeddinVivek PurohitKazuko Sagawa Correction Open access 21 February 2024 Article: 27
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates Jie ChenLloyd Wei Tat TangLi Di Research Article 16 February 2024 Article: 26
Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies Shravan SreenivasanAnurag S. Rathore Research Article 14 February 2024 Article: 25
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development Amanda HaysMark WisselOskar Johansson White Paper Open access 05 February 2024 Article: 24
Agreement Between a Colorimetric Assay and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Quantifying Paracetamol Plasma Concentrations Angela Elma EdwinaErwin DreesenJos Tournoy Research Article 01 February 2024 Article: 23
An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing Hirokazu WakudaYue XiangLeslie Z. Benet Research Article Open access 30 January 2024 Article: 22