Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 2

Results: 9

A Short Update on the Use of Monoclonal Antibodies in COVID-19.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00904-y
By:
- Vitiello, Antonio;
- Sabbatucci, Michela;
- Ponzo, Annarita;
- Salzano, Antonio;
- Zovi, Andrea
Publication type:
Article
Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00903-z
By:
- McCaig, Lori;
- Nowak, Steven;
- Abbott, Alexander;
- Carhart, Jenny;
- McMahon, Megan E.;
- Debie, Elke;
- Li, Hanlin;
- Maina, Francis;
- Ji, Andrea J.;
- Fu, Mingkun;
- Wu, Yan;
- Lennard, Andrew;
- Mazzeo, Tony;
- Wolfe, Chad;
- Timpano, Robert;
- Babayan, Yelizaveta;
- Gruenig, Lars
Publication type:
Article
Quality by Design Framework Applied to GMMA Purification.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00902-0
By:
- Giannelli, Carlo;
- Necchi, Francesca;
- Palmieri, Elena;
- Oldrini, Davide;
- Ricchetti, Beatrice;
- Papathanasiou, Maria M.;
- Kis, Zoltan;
- Kontoravdi, Cleo;
- Campa, Cristiana;
- Micoli, Francesca
Publication type:
Article
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00901-1
By:
- Williams, Jason H.;
- Liao, Kai H.;
- Yin, Donghua;
- Meng, Xu
Publication type:
Article
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00899-6
By:
- Opolka-Hoffmann, Eugenia;
- Edelmann, Martin R.;
- Otteneder, Michael B.;
- Hauri, Simon;
- Jordan, Gregor;
- Schrag, Peter;
- Lechmann, Martin;
- Winter, Gerhard;
- Staack, Roland F.
Publication type:
Article
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00898-7
By:
- Wu, Shengjia;
- Chang, Hsueh-Yuan;
- Chowdhury, Ekram Ahmed;
- Huang, Hsien Wei;
- Shah, Dhaval K.
Publication type:
Article
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00897-8
By:
- Fang, Lanyan;
- Gong, Yuqing;
- Hooker, Andrew C.;
- Lukacova, Viera;
- Rostami-Hodjegan, Amin;
- Sale, Mark;
- Grosser, Stella;
- Jereb, Rebeka;
- Savic, Rada;
- Peck, Carl;
- Zhao, Liang
Publication type:
Article
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model.
Published in:
2024
By:
- Saadeddin, Anas;
- Purohit, Vivek;
- Huh, Yeamin;
- Wong, Mei;
- Maulny, Aurelia;
- Dowty, Martin E.;
- Sagawa, Kazuko
Publication type:
Correction Notice
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates.
Published in:
AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00894-x
By:
- Chen, Jie;
- Tang, Lloyd Wei Tat;
- Jordan, Samantha;
- Harrison, Makayla;
- Gualtieri, Gabrielle M.;
- DaSilva, Ethan;
- Morris, Danial;
- Bora, Gary;
- Che, Ye;
- Di, Li
Publication type:
Article