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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
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
Recent Advances in Drug Delivery.
Published in:
2024
By:
- Salem, Aliasger K.
Publication type:
Editorial
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Found: 27

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

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

Recent Advances in Drug Delivery.

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.

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

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

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.

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

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.

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.

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.

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

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

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.

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

Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery.

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.