Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 3

Results: 27

Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00931-9

By:

Sorret, Léa;
Tan, Wei Han;
Voss, Senta;
Favrod, Patrick;
Chalus, Pascal;
Winzer, Matthias

Publication type:

Article

Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00930-w

By:

Felderman, Jacob;
Ramaiah, Lila;
Vazquez-Abad, Maria-Dolores;
Messing, Dean;
Chen, Ying

Publication type:

Article

Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables?

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00929-3

By:

Zhang, Tan;
Calvier, Elisa A. M.;
Krekels, Elke H. J.;
Knibbe, Catherijne A. J.

Publication type:

Article

Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00905-x

By:

Guhl, Mélanie;
Bertrand, Julie;
Fayette, Lucie;
Mercier, François;
Comets, Emmanuelle

Publication type:

Article

Correction: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

Published in:

2024

By:

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

Publication type:

Correction Notice

Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS).

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00925-7

By:

Hendrickx, Niels;
Mentré, France;
Traschütz, Andreas;
Gagnon, Cynthia;
Schüle, Rebecca;
Synofzik, Matthis;
Comets, Emmanuelle

Publication type:

Article

Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.

Published in:

2024

By:

Tsakalozou, Eleftheria;
Gong, Yuqing;
Babiskin, Andrew;
Hu, Meng;
Mousa, Youssef;
Walenga, Ross;
Wu, Fang;
Yoon, Miyoung;
Raney, Sam G.;
Polli, James E.;
Schwendeman, Anna;
Krishnan, Vishalakshi;
Fang, Lanyan;
Zhao, Liang

Publication type:

Editorial

Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00923-9

By:

Pepin, Xavier J. H.;
Suarez-Sharp, Sandra

Publication type:

Article

Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00922-w

By:

Paudwal, Gourav;
Dolkar, Rigzin;
Perveen, Summaya;
Sharma, Rashmi;
Singh, Parvinder Pal;
Gupta, Prem N.

Publication type:

Article

Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00921-x

By:

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

Publication type:

Article

Recent Advances in Drug Delivery.

Published in:

2024

By:

Salem, Aliasger K.

Publication type:

Editorial

Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m6A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00919-5

By:

Liu, Rong;
Wang, Qiang;
Li, Yao;
Wan, Ruixue;
Yang, Ping;
Yang, Dexing;
Tang, Jiefu;
Lu, Jiafei

Publication type:

Article

Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00918-6

By:

Kato, Masaru;
Maruyama, Shinichi;
Watanabe, Noriko;
Yamada, Risa;
Suzaki, Yuki;
Ishida, Masaru;
Kanno, Hiroshi

Publication type:

Article

Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00917-7

By:

Kwok, Rosanna S.;
Nijem, Ihsan;
Brady, Ann;
Hendricks, Robert

Publication type:

Article

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.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00916-8

By:

Pal, Arindom;
Wu, Fang;
Walenga, Ross;
Tsakalozou, Eleftheria;
Alam, Khondoker;
Gong, Yuqing;
Zhao, Liang;
Fang, Lanyan

Publication type:

Article

LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00915-9

By:

Malani, Himanshu;
Shrivastava, Anuj;
Nupur, Neh;
Rathore, Anurag S.

Publication type:

Article

Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00914-w

By:

Ballman, Kimberly K.;
Peek, Victoria L.;
Sloan, John H.;
Li, Jingling;
Konrad, Robert J.;
Wen, Yi

Publication type:

Article

Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00913-x

By:

Li, Shuhui;
Feng, Kairui;
Lee, Jieon;
Gong, Yuqing;
Wu, Fang;
Newman, Bryan;
Yoon, Miyoung;
Fang, Lanyan;
Zhao, Liang;
Gobburu, Jogarao V. S.

Publication type:

Article

Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00912-y

By:

Kowthavarapu, Venkata Krishna;
Charbe, Nitin Bharat;
Gupta, Churni;
Iakovleva, Tatiana;
Stillhart, Cordula;
Parrott, Neil John;
Schmidt, Stephan;
Cristofoletti, Rodrigo

Publication type:

Article

Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00911-z

By:

Agboluaje, Elizabeth Oladoyin;
Cui, Shuolin;
Grimsey, Neil J.;
Xiong, May P.

Publication type:

Article

PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00910-0

By:

Chen, Lu;
Dombrowsky, Erin;
Boyle, Baylea;
Tang, Chengke;
Thanneer, Neelima

Publication type:

Article

Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00909-7

By:

Xu, Weifeng;
Bano, Nazneen;
Guzman-Valdes, Olguitza;
Amberman, Jessica;
Bandlamudi, Elisha;
Khanna, Pooja;
Carmean, Rebecca;
Helmy, Roy

Publication type:

Article

Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00908-8

By:

Liu, Jianhua;
Vernikovskaya, Daria;
Bora, Gary;
Carlo, Anthony;
Burchett, Woodrow;
Jordan, Samantha;
Tang, Lloyd Wei Tat;
Yang, Joy;
Che, Ye;
Chang, George;
Troutman, Matthew D.;
Di, Li

Publication type:

Article

Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00907-9

By:

Zhang, Sam;
Orozco, Christine C.;
Tang, Lloyd Wei Tat;
Racich, Jillian;
Carlo, Anthony A.;
Chang, George;
Tess, David;
Keefer, Christopher;
Di, Li

Publication type:

Article

State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00906-w

By:

Yu, Joshua;
Dan, Nirnoy;
Eslami, Seyyed Majid;
Lu, Xiuling

Publication type:

Article

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.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00900-2

By:

Lay-Fortenbery, Ashley;
Tower, Cole W.;
Ezeajughi, Ernest;
Calahan, Julie;
Duru, Chinwe;
Matejtschuk, Paul;
Munson, Eric J.

Publication type:

Article

Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing.

Published in:

AAPS Journal, 2024, v. 26, n. 3, p. 1, doi. 10.1208/s12248-024-00896-9

By:

Wilson, Selina;
Farabaugh, Julianne;
Liu, Yemin;
Liu, Zhao;
Meyers, Rachel;
Santangelo, Matthew;
Thompson, Karen

Publication type:

Article

Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 3

Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands.

Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route.

Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables?

Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm.

Correction: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS).

Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.

Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling.

Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity.

Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies.

Recent Advances in Drug Delivery.

Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m<sup>6</sup>A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway.

Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations.

Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method.

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.

LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics.

Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety.

Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability.

Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling.

Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine.

PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications.

Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate.

Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes.

Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery.

State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies.

Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature on <sup>1</sup>H T<sub>1</sub> Relaxation Times.

Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing.