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