Works matching IS 15507416 AND DT 2025 AND VI 27 AND IP 4

Results: 32

Factors Impacting the Immunogenicity of Etrolizumab & Clinical Consequences.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01090-1

By:

Sperinde, Gizette;
Webb-Vargas, Yenny;
Hu, Zicheng;
Saha, Ashis;
Hammer, Christian;
Erickson, Richard;
Eden, Chris;
Galloway, Deanna;
Jacob-Moffatt, Rhian;
Siradze, Ketevan;
Nguyen, Van;
Fischer, Saloumeh K.

Publication type:

Article

Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip® Columns for Sample Pretreatment in an Immunogenicity Assay.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01092-z

By:

Luong, Michael;
Zhang, Minlei;
Djura, Ihor;
Wang, Ying;
Joyce, Alison

Publication type:

Article

Correction: Nitrosamines Risk Assessment for Biopharmaceutics Classifcation System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokinetic Modeling.

Published in:

2025

By:

Kollipara, Sivacharan;
Chougule, Mahendra;
Parsa, Karthik;
Pandya, Priyansh;
Ahmed, Tausif

Publication type:

Correction Notice

The 100<sup>th</sup> Monoclonal Antibody Product is Approved in Japan.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01091-0

By:

Hariu, Aya;
Shirahata, Yukiko;
Shinohara, Kayo;
Kuribayashi, Ryosuke

Publication type:

Article

Improving the Therapeutic Selectivity of Trastuzumab Deruxtecan Using 8C2 Fab Fragments.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01087-w

By:

Gong, Jue;
Bordeau, Brandon M.;
Balthasar, Joseph P.

Publication type:

Article

Correction: Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling.

Published in:

2025

By:

Wang, Xiaofeng;
Li, Longjie;
Yang, Hongyi;
He, Qingfeng;
Zhu, Xiao;
Wang, Jiajing;
Sun, Bo;
Liu, Peng;
Xiang, Xiaoqiang

Publication type:

Correction Notice

Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01075-0

By:

Mao, Bingyu;
Gao, Yue;
Xu, Christine;
Macha, Sreeraj;
Shao, Shuai;
Ahamadi, Malidi

Publication type:

Article

A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01061-6

By:

Cross, Charlotte;
Martinez, Marilyn N.;
Pade, Devendra;
Myers, Michael J.;
Neuhoff, Sibylle

Publication type:

Article

A Comparative Study on Physicochemical and Analytical Characterizations of Doxil® and its Generic Drug Products.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01058-1

By:

Eneli, Adaeze;
Wang, Kaikai;
Gan, Jingyao;
Diwan, Rimpy;
Lu, Ziyi;
Yu, Minzhi;
Ackermann, Rose;
Shay, Brian;
Schwendeman, Anna

Publication type:

Article

Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01084-z

By:

Liu, Qunhui;
Chu, Ka Po;
Cardenas, Armando;
Liu, Xiaoyang;
Liu, Dingjiang;
Shameem, Mohammed;
Hu, Qingyan

Publication type:

Article

Publisher Correction: Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models.

Published in:

2025

By:

Hu, Yuming;
Scotcher, Daniel

Publication type:

Correction Notice

Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokinetic Modeling.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01086-x

By:

Kollipara, Sivacharan;
Chougule, Mahendra;
Parsa, Karthik;
Pandya, Priyansh;
Ahmed, Tausif

Publication type:

Article

Short-Term Immunosuppression in Rats Induces Prolonged Immune Tolerance Towards a Human Monoclonal Antibody, Erenumab.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01083-0

By:

Gupta, Paridhi;
Srivastava, Ashish;
Ryman, Josiah T.;
Swanson, Michael D.;
Kozhich, Alexander;
Jawa, Vibha;
Meibohm, Bernd

Publication type:

Article

Application of Real-World Evidence to Support FDA Regulatory Decision Making.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01082-1

By:

Khaowroongrueng, Vipada;
Kim, Tae-Eun;
Park, Sang-In;
Shin, Kwang-Hee

Publication type:

Article

Publisher Correction: Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data.

Published in:

2025

By:

Cleary, Yumi;
Milani, Nicolo;
Ogungbenro, Kayode;
Aarons, Leon;
Galetin, Aleksandra;
Gertz, Michael

Publication type:

Correction Notice

Social Inequality and Antimicrobial Resistance: An Interconnected Global Problem.

Published in:

2025

By:

Vitiello, Antonio;
Zovi, Andrea

Publication type:

Letter

Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01079-w

By:

Duarte, Joana Galvão;
Duarte, Maria Galvão;
Piedade, Ana Paula;
Mascarenhas-Melo, Filipa

Publication type:

Article

Removal of Excipients from Drug Product may Impact Antibody Characterization of Monoclonal Antibodies.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01078-x

By:

Krishna, Kunal;
Sarin, Deepika;
Trivedi, Drashti;
Bhattacharya, Sanghati;
Refaat, Hesham;
Ahmad, Aziz;
Nejadnik, Reza;
Rathore, Anurag S.

Publication type:

Article

Investigations of Influence of Antibody Binding Kinetics on Tumor Distribution and Anti-Tumor Efficacy.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01076-z

By:

Chen, Ping;
Bordeau, Brandon M.;
Zhang, Wenqiu;
Balthasar, Joseph P.

Publication type:

Article

Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01074-1

By:

Wang, Xiaofeng;
Li, Longjie;
Yang, Hongyi;
He, Qingfeng;
Zhu, Xiao;
Wang, Jiajing;
Sun, Bo;
Liu, Peng;
Xiang, Xiaoqiang

Publication type:

Article

TLR7-Adjuvanted Ionizable Lipid Nanoparticles for mRNA Vaccine Delivery.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01073-2

By:

Misra, Bishal;
Hughes, Krystal A.;
Pentz, William H.;
Surface, Morgan;
Geldenhuys, Werner J.;
Bobbala, Sharan

Publication type:

Article

IFN-γ/IL-2 Double-Color FluoroSpot Assay for Monitoring Human Primary T Cell Activation: Validation, Inter-Laboratory Comparison, and Recommendations for Clinical Studies.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01072-3

By:

Mauthe, Alexandra;
Cedrone, Edward;
Villar-Hernández, Raquel;
Rusch, Elisa;
Springer, Marco;
Schuster, Martin;
Preyer, Rosemarie;
Dobrovolskaia, Marina A.;
Gutekunst, Matthias

Publication type:

Article

Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01071-4

By:

Sychterz, Caroline;
Chen, Ping;
Saxena, Ajay;
Lin, Hongxia;
Chen, Lu;
Li, Yan;
Gaohua, Lu;
Cheng, Yiming

Publication type:

Article

Improvement of Drug Release from an Aptamer Drug Conjugate Using Reductive-sensitive Linkers for Tumor-targeted Drug Delivery.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01070-5

By:

Wu, You;
Kawamoto, Yusuke;
Sun, Jin;
Takahashi, Yuki;
Higuchi, Yuriko;
Takakura, Yoshinobu

Publication type:

Article

Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01069-y

By:

Zhao, Yue;
Li, Li;
Ma, Jessica;
Roy, Amit;
Bello, Akintunde;
Sheng, Jennifer;
Hamuro, Lora

Publication type:

Article

Assessing the Impact of Multiple Imputation Algorithms on Pharmacokinetic Model Performance: A Simulation-Based Study.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01066-1

By:

Duflot, Thomas;
Fayette, Lucie;
Konecki, Céline;
Seurat, Jérémy;
Feliu, Catherine;
Scala-Bertola, Julien;
Djerada, Zoubir

Publication type:

Article

The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01065-2

By:

Ibrahim, Moustafa M. A.;
Jonsson, E. Niclas;
Bergstrand, Martin

Publication type:

Article

Simultaneous Estimation of fm and F<sub>G</sub> Values Directly from Clinical Drug-Drug Interaction Study Data.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01064-3

By:

Cleary, Yumi;
Milani, Nicolo;
Ogungbenro, Kayode;
Aarons, Leon;
Galetin, Aleksandra;
Gertz, Michael

Publication type:

Article

Physiologically Based Modeling of Cefoxitin, Cefazolin, and Piperacillin Pharmacokinetics in Obese and Lean Rats.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01063-4

By:

Sheng, Yi-Hua;
Kosicka-Noworzyń, Katarzyna;
Siemiątkowska, Anna;
Yu, Sijia;
Rosa, Raymond;
Sapra, Karan;
Awad, Marian;
Khalil, Justine;
Doss, Thomas;
Yohn, Christine;
Brunetti, Luigi;
Kagan, Leonid

Publication type:

Article

Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01062-5

By:

Hu, Yuming;
Scotcher, Daniel

Publication type:

Article

An Ocular Exposure Prediction for Topical Atropine in Human Using Physiologically Based Pharmacokinetic Modeling.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01052-7

By:

Zheng, Aole;
Han, Tian;
Bu, Fengjiao;
He, Qingfeng;
Shang, Jianmin;
Ho, Paul Chi Lui;
Xiang, Xiaoqiang;
Zhou, Xingtao;
Huang, Taomin

Publication type:

Article

The Use of Surrogate Matrix for Calibrators in the Analysis of Dried Blood Samples – A Feasibility Study.

Published in:

AAPS Journal, 2025, v. 27, n. 4, p. 1, doi. 10.1208/s12248-025-01040-x

By:

Lee, Dong Hun;
Xie, Iris;
Solomon, Matthew;
Wang, Ming;
Luo, Linlin;
Woolf, Eric

Publication type:

Article