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