Works matching IS 15507416 AND DT 2025 AND VI 27 AND IP 1

Results: 46

Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan.

Published in:

2025

By:

Ishibai, Mitsuru;
Kai, Megumi;
Wakuda, Hirokazu;
Oikawa, Ichiro;
Uemura, Naoto

Publication type:

Correction Notice

Development of a PBPK Model for Lamotrigine which Incorporates Metabolism by UGT2B10: Impact of UGT2B10 Poor Metabolizer Phenotype and Pregnancy.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01025-w

By:

Gardner, Iain;
Heikkinen, Aki T.;
Tang, Lloyd Wei Tat;
Lapham, Kimberly;
Goosen, Theunis C.

Publication type:

Article

PK/PD Evaluation of Antibody–Drug Conjugates with Enhanced Immune Effector Functions.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00998-4

By:

Chang, Hsuan-Ping;
Liu, Shufang;
Shah, Dhaval K.

Publication type:

Article

Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00995-7

By:

Orr, Robert K.;
Rawalpally, Thimma;
Gorka, Lindsey Saunders;
Bonaga, Llorente R.;
Schenck, Luke;
Osborne, Stacy;
Erdemir, Deniz;
Timpano, Robert J.;
Zhang, Haitao

Publication type:

Article

Prediction of Area Under the Curve from Urinary Vancomycin Concentrations Measured Using a Simple Method.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01021-0

By:

Oshima, Yuki;
Matsumoto, Miyu;
Munakata, Sumika;
Tokimatsu, Issei;
Hattori, Norimichi;
Kotani, Toru;
Kusumoto, Sojiro;
Sagara, Hironori;
Kato, Masaru

Publication type:

Article

Bioanalytical Method Comparison Strategy for Clinical Anti-drug Antibody Immunoassays.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00999-3

By:

Elliott, R. J.;
Pourmohamad, T.;
Webb-Vargas, Y.;
Yan, W.;
Nijem, I.;
Siguenza, P.;
Song, Y.

Publication type:

Article

Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00983-x

By:

Her, Cheng;
Thacker, Seth;
Balsamo, Joseph;
Kelley Baker, Logan;
Ireland, Derek DC;
Pang, Eric;
Verthelyi, Daniela

Publication type:

Article

Quantitative Comparison and Clustering of Circular Dichroism Spectra Using a Symmetrized Weighted Spectral Difference.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01005-6

By:

Chouchane, Karim;
Kirkitadze, Marina;
Misra, Rahul;
Kowal, Przemyslaw;
Dalloz-bourguignon, Olivier;
Greco, Frederic;
Fayard, Sylvie;
Marco, Sergio;
Clenet, Didier

Publication type:

Article

Stability of Anti-Drug Antibodies Against Antibody Therapeutics.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01030-z

By:

Sirohi, Parul;
Hainline, Kelly;
Bullock, Heather;
Wang, Sihe;
Konrad, Robert J.;
Wen, Yi

Publication type:

Article

Pharmacokinetic-pharmacodynamic Modelling of NH600001 in Healthy Subjects and Patients Undergoing Gastroscopy.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01004-7

By:

Liu, Yaxin;
Kuang, Yun;
Huang, Jie;
Jiang, Dan;
Cao, Yajie;
Gao, Qi;
Li, Zifeng;
Ouyang, Wen;
Wang, Saiying;
Pei, Qi;
Yang, Guoping

Publication type:

Article

Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01031-y

By:

Abduljalil, Khaled;
De Sousa Mendes, Mailys;
Salem, Farzaneh;
Benaboud, Sihem;
Gardner, Iain

Publication type:

Article

A Highly Sensitive Immunoassay to Enable Quantification of a Nanobody-Based Imaging Agent in Human Serum.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01029-6

By:

Guelman, Sebastian;
Huang, Catherine;
Peng, Kun

Publication type:

Article

Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01020-1

By:

Anim Anno, Krista;
Mina, Mirette;
Zhang, Zhen;
Zhang, Lei;
Jiang, Wenlei

Publication type:

Article

Pharmaceutical Sciences: Insights and Observations from Academic Chairs and Vice Chairs.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01026-9

By:

Ainslie, Kristy M.;
Bowers, Albert A;
Chichewicz, Robert H.;
Collier, Lara S.;
Doorn, Jonathan A.;
Frei, Christopher R.;
Ghandehari, Hamidreza;
Gibbs, Robert B.;
Lawrence, David S.;
Lee, Craig R.;
Mager, Donald E.;
Marker, Paul;
Schwendeman, Anna;
Suryanarayanan, Raj;
Williams III, Robert O.;
Xi, Yaguang;
Xie, Wen;
Xie, Xiang-Qun;
Zhu, Guizhi;
Nguyen, Juliane

Publication type:

Article

Correction: Tumor-Targeted Chemoimmunotherapy with Immune-Checkpoint Blockade for Enhanced Anti-Melanoma Efficacy.

Published in:

2025

By:

Li, Man;
Yang, Yuting;
Xu, Chaoqun;
Wei, Jiaojie;
Liu, Yingke;
Cun, Xingli;
Yu, Qianwen;
Tang, Xian;
Yin, Sheng;
Zhang, Zhirong;
He, Qin

Publication type:

Correction Notice

Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01024-x

By:

Wan, Zhijie;
Yuan, Ming;
Liu, Ziao;
Cai, Yuan;
He, Hua;
Hao, Kun

Publication type:

Article

Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00992-w

By:

Zeng, Lingjun;
Wang, Youye;
Liu, Zhihong;
Hu, Xiaomu;
Zheng, Changqing;
Yao, Lingyan;
Zhang, Minxin;
Feng, Xianquan;
Song, Hongtao

Publication type:

Article

Mechanistic Approach into 1,2,3-triazoles-based IIIM(S)-RS98 Mediated Apoptosis in Lung Cancer Cells.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01018-9

By:

Dolkar, Rigzin;
Paudwal, Gourav;
Singh, Davinder;
Behera, Chittaranjan;
Malik, Sumera Banoo;
Ali, Syed Mudassir;
Kaur, Harjot;
Nargotra, Amit;
Shankar, Ravi;
Singh, Shashank K.;
Gupta, Prem N.

Publication type:

Article

Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00991-x

By:

Jang, Dawon;
Kim, Jaeil;
Jo, Youngwon;
Lee, Hyuna;
Go, Ahra;
Kim, Jieun;
Choi, Soyoung

Publication type:

Article

Impact of Weak Vibration Generated by a Refrigerator on Protein Aggregation.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01014-z

By:

Kizuki, Shinji;
Wang, Zekun;
Yamauchi, Satoru;
Torisu, Tetsuo;
Uchiyama, Susumu

Publication type:

Article

Gastrointestinal Bile Salt Concentrations in Healthy Adults Under Fasted and Fed Conditions: A Systematic Review and Meta-Analysis for Mechanistic Physiologically-Based Pharmacokinetic (PBPK) Modelling.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01016-x

By:

Santos, Laura G. Al-Amiry;
Musther, Helen;
Bala, Neeru;
Deferm, Neel;
Patel, Gaurangkumar;
Brouwers, Joachim;
Turner, David B.

Publication type:

Article

Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01019-8

By:

Gupta, Sana;
Purohit, Vivek;
Wang, Yuchen;
Prybylski, John P.

Publication type:

Article

Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01003-8

By:

Hu, Zicheng;
Wu, Patrick;
Swanson, Steven J.

Publication type:

Article

Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-025-01015-y

By:

Santos Gomes, Bernardo Filipe;
Bya, Laure-Anne;
Koch, Nathan;
Cabral-Marques, Helena;
Evrard, Brigitte;
Lechanteur, Anna

Publication type:

Article

Formulation Factors Affecting the Formation of Visible-Bubbles During the Reconstitution Process of Freeze-Dried Etanercept Formulations: Protein Concentration, Stabilizers, and Surfactants.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01009-2

By:

Gao, Han;
Du, Chao-Yang;
Zheng, Aiping;
Qian, Ci;
Fang, Wei-Jie

Publication type:

Article

Early and Mid-Term Disposition of α-PVP and its unknown Metabolites in Urine and Oral Fluid Through a Multi-Analytical Hyphenated Approach Following a Single Non-Controlled Administration to Healthy Volunteers.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01012-7

By:

Di Trana, Annagiulia;
La Maida, Nunzia;
de la Rosa, Georgina;
Di Giorgi, Alessandro;
Graziano, Silvia;
Aldhaehri, Khaled;
Papaseit, Esther;
Hladun, Olga;
Farré, Magí;
Pérez, Clara;
Pichini, Simona

Publication type:

Article

Simultaneous Quantification of Total Antibody and Conjugated Payload for DS001 in Rat Serum Using a Hybrid Immuno-Capture LC–MS/MS.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01007-4

By:

Yu, Xiong;
Li, Weiqiang;
Huang, Wensi;
Xiao, Bo;
Long, Jing;
Wang, Qi;
Wang, Guifeng;
Wang, Chunhe;
Yu, Mingming;
Yu, Jinghua;
Diao, Xingxing

Publication type:

Article

Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation.

Published in:

2025

By:

Zhong, Hao;
Lu, Tianshu;
Wang, Ruifeng;
Ouyang, Defang

Publication type:

Correction Notice

Comparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle–Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK Studies.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01002-9

By:

Ortiz, Jessica;
Brunner, Laura;
Ci, Lei;
Baek, Rena;
Jani, Darshana;
Marshall, Jean-Claude;
Pennucci, Jason

Publication type:

Article

Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRAS<sup>G12C</sup> Mutation from Phase 1 and Phase 2 Studies.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01013-6

By:

Nagase, Mario;
Houk, Brett;
Vuu, Irene;
Cardona, Panli;
Dutta, Sandeep;
Lin, Chih-Wei

Publication type:

Article

Meta-Analysis of the Input and Disposition of Various Dosage Forms of Methylprednisolone in Healthy Subjects Utilizing a Physiologically Based Pharmacokinetic Model: Pharmacokinetics of Methylprednisolone in Humans: Yu and Jusko.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01011-8

By:

Yu, Ruihong;
Jusko, William J.

Publication type:

Article

Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01006-5

By:

Ajmal, C. S.;
Yerram, Sravani;
Abishek, V.;
Nizam, V. P. Muhammed;
Aglave, Gayatri;
Patnam, Jayasri Devi;
Raghuvanshi, Rajeev Singh;
Srivastava, Saurabh

Publication type:

Article

Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00997-5

By:

Moghassemi, Saeid;
Dadashzadeh, Arezoo;
Lucci, Carolina M.;
Amorim, Christiani A.

Publication type:

Article

Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01006-5

By:

Ajmal, C. S.;
Yerram, Sravani;
Abishek, V.;
Nizam, V. P. Muhammed;
Aglave, Gayatri;
Patnam, Jayasri Devi;
Raghuvanshi, Rajeev Singh;
Srivastava, Saurabh

Publication type:

Article

Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00994-8

By:

Rogers-Crovak, Jessica A.;
Delaney, Edward J.;
Detlefsen, David J.

Publication type:

Article

Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00996-6

By:

Liu, Wenyu;
Yang, Jie;
Yan, Weili;
Peng, Kun

Publication type:

Article

Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00990-y

By:

Rezaei Aghdam, Hadi;
Peymani, Maryam;
Salehzadeh, Ali;
Rouhi, Leila;
Zarepour, Atefeh;
Zarrabi, Ali

Publication type:

Article

Interference of Plasticizers on Plasma Protein Binding Measurements.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00988-6

By:

Harrison, Makayla;
Jordan, Samantha;
Di, Li

Publication type:

Article

Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00993-9

By:

Lai, Ching-Ha;
Chen, Mu;
Fraser, Sasha;
Wang, Jessica;
McAfee, Sean;
Speaks, Emma;
Simeone, Nicholas;
Rodriguez, Jacqueline;
Stefan, Colin;
DeStefano, Lisa;
Elango, Chinnasamy;
Andisik, Matthew D.;
Sumner, Giane;
Zhao, An;
Irvin, Susan C.;
Torri, Albert;
Partridge, Michael A.

Publication type:

Article

Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00987-7

By:

Tess, David;
Harrison, Makayla;
Lin, Jian;
Li, Rui;
Di, Li

Publication type:

Article

Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00986-8

By:

Hernández, Magali;
Lima, Enrique;
Magaña, Jonathan J.;
Ganem-Rondero, Adriana

Publication type:

Article

A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00984-w

By:

Liu, Susana;
Qu, Qiang;
You, Zhiping;
Steeno, Gregory S.;
Tan, Charles Y.;
Dyleski, Lisa A.;
Wang, Ying;
Baltrukonis, Dan

Publication type:

Article

Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-00973-z

By:

Jiang, Tingting;
Kwofie, Francis;
Attanasio, Nick;
Haas, Matthew;
Higgins, John;
Kosanam, Hari

Publication type:

Article

Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01001-w

By:

Zhong, Hao;
Lu, Tianshu;
Wang, Ruifeng;
Ouyang, Defang

Publication type:

Article

Evaluation of Incurred Subject Period Re-analysis (ISPR) as a Tool to Distinguish Fraudulent Pharmacokinetic Profile Pairs from Non-fraudulent Pairs.

Published in:

AAPS Journal, 2025, v. 27, n. 1, p. 1, doi. 10.1208/s12248-024-01000-x

By:

Fuglsang, Anders;
Dogra, Anshul;
Sharma, Naveen

Publication type:

Article

Rejoinder to the 'Letter to the Editor' on "Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies".

Published in:

2025

By:

Schütz, Helmut;
Burger, Divan A.;
Cobo, Erik;
Dubins, David;
Farkás, Tibor;
Labes, Detlew;
Lang, Benjamin;
Ocaña, Jordi;
Ring, Arne;
Shitova, Anastasia;
Stus, Volodymyr;
Tomashevskiy, Michael

Publication type:

Letter