Works matching IS 15507416 AND DT 2022 AND VI 24 AND IP 4

Results: 16

Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00729-7

By:

Partridge, Michael A.;
Chen, Jihua;
Karayusuf, Elif Kabuloglu;
Sirimanne, Thanoja;
Stefan, Colin;
Lai, Ching Ha;
Gathani, Meghna;
DeStefano, Lisa;
Rozanski, Michal;
McAfee, Sean;
Rajadhyaksha, Manoj;
Andisik, Matthew D.;
Torri, Albert;
Sumner, Giane

Publication type:

Article

Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00720-2

By:

Yao, Bing;
Gao, Xiao;
Dan, Mo;
Yuan, Can;
Hu, Xixin;
Sun, Zhaopeng;
Hui, Xiwu;
Liu, Boning;
Ouyang, Pingkai;
Chen, Guoguang

Publication type:

Article

Correction: International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.

Published in:

2022

By:

Keire, David A.;
Bream, Robert;
Wollein, Uwe;
Schmaler-Ripcke;
Burchardt, Annette;
Conti, Massimiliano;
Zmysłowski, Adam;
Keizers, Peter;
Morin, Justin;
Poh, Jalene;
George, Mark;
Wierer, Michael

Publication type:

Correction Notice

Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00731-z

By:

Thakur, Garima;
Masampally, Vishnu;
Kulkarni, Amey;
Rathore, Anurag S.

Publication type:

Article

Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00728-8

By:

Starcevic Manning, Marta;
Hassanein, Mohamed;
Partridge, Michael A.;
Jawa, Vibha;
Mora, Johanna;
Ryman, Josiah;
Barker, Breann;
Braithwaite, Christian;
Carleton, Kevin;
Hay, Laura;
Hottenstein, Charles;
Kubiak, Robert J.;
Devanarayan, Viswanath

Publication type:

Article

Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00725-x

By:

Rish, Adam J.;
Henson, Samuel R.;
Alam, Md. Anik;
Liu, Yang;
Drennen, James K.;
Anderson, Carl A.

Publication type:

Article

Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00730-0

By:

Li, Ruo-Jing;
Ma, Lian;
Kim, Hyewon;
Kim, Insook;
Hanes, Lesley;
Altepeter, Tara;
Lee, Jessica;
Liu, Jiang;
Zhu, Hao;
Wang, Yaning

Publication type:

Article

Pharmacokinetics of Gentamicin Components C1, C1a, and C2/C2a/C2b and Subsequent Decline in Glomerular Filtration Rate in Neonates.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00727-9

By:

Soeorg, Hiie;
Padari, Helgi;
Kipper, Karin;
Ilmoja, Mari-Liis;
Lutsar, Irja;
Metsvaht, Tuuli

Publication type:

Article

A Simulation Study of the Comparative Performance of Partial Area under the Curve (pAUC) and Partial Area under the Effect Curve (pAUEC) Metrics in Crossover Versus Replicated Crossover Bioequivalence Studies for Concerta and Ritalin LA.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00726-w

By:

Jackson, Andre J.;
Foehl, Henry C.

Publication type:

Article

Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00724-y

By:

Irvin, Susan C.;
D'Orvilliers, Amanda;
Bloch, Nicolin;
Boccio, Kayla;
Pennucci, Jason;
Brouwer-Visser, Jurriaan;
Ullman, Erica;
Rajadhyaksha, Manoj;
Hassanein, Mohamed;
Potocky, Terra;
Torri, Albert;
Hermann, Aynur;
Partridge, Michael A.

Publication type:

Article

Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00723-z

By:

Renu, Sankar;
Shank-Retzlaff, Mary;
Sharpe, Jenny;
Bronsart, Laura;
Mohanty, Pravansu

Publication type:

Article

Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00722-0

By:

Gill, Katherine L.;
Jones, Hannah M.

Publication type:

Article

Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00719-9

By:

Noh, Keumhan;
Chow, Edwin C. Y.;
Quach, Holly P.;
Groothuis, Geny M. M.;
Tirona, Rommel G.;
Pang, K. Sandy

Publication type:

Article

Correction: Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration.

Published in:

2022

By:

Chang, Hsueh-Yuan;
Wu, Shengjia;
Li, Yingyi;
Guo, Leiming;
Li, Yuelin;
Shah, Dhaval K.

Publication type:

Correction Notice

Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00717-x

By:

Liao, Kai H.;
Williams, Jason H.;
Palani, Santhosh;
Yin, Donghua;
Meng, Xu

Publication type:

Article

Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00706-0

By:

Nagy, Brigitta;
Galata, Dorián László;
Farkas, Attila;
Nagy, Zsombor Kristóf

Publication type:

Article