Works matching IS 15507416 AND DT 2020 AND VI 22 AND IP 1

Results: 17

Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0397-8

By:

Thway, T. M.;
Wang, Y. M.;
Booth, B. P.;
Maxfield, K.;
Huang, S. M.;
Zineh, I.

Publication type:

Article

Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0396-9

By:

Abend, Andreas;
Xiong, Leah;
Zhang, Xiaohua;
Frankenfeld, Celeste;
Kesisoglou, Filippos;
Reuter, Kevin;
Kotwal, Pramod

Publication type:

Article

Deconvolution Analysis by Non-linear Regression Using a Convolution-Based Model: Comparison of Nonparametric and Parametric Approaches.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0389-8

By:

Gomeni, Roberto;
Bressolle-Gomeni, Françoise

Publication type:

Article

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0386-y

By:

Civoli, Francesca;
Kasinath, Aparna;
Cai, Xiao-Yan;
Wadhwa, Meenu;
Exley, Andrew;
Oldfield, Philip;
Alvandkouhi, Safa;
Schaffar, Gregor;
Chappell, John;
Bowsher, Ronald;
Devanarayan, Viswanath;
Marini, Joseph;
Rebarchak, Shannon;
Anderson, Michael;
Koppenburg, Vera;
Lester, Todd

Publication type:

Article

Impact of Interleukin-6 on Drug-Metabolizing Enzymes and Transporters in Intestinal Cells.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0395-x

By:

Simon, Florian;
Garcia, Jessica;
Guyot, Laetitia;
Guitton, Jérôme;
Vilchez, Gaelle;
Bardel, Claire;
Chenel, Marylore;
Tod, Michel;
Payen, Léa

Publication type:

Article

An Investigation into the Factors Governing Drug Absorption and Food Effect Prediction Based on Data Mining Methodology.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0394-y

By:

Gatarić, Biljana;
Parojčić, Jelena

Publication type:

Article

Epigenome and transcriptome study of moringa isothiocyanate in mouse kidney mesangial cells induced by high glucose, a potential model for diabetic-induced nephropathy.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0393-z

By:

Li, Shanyi;
Li, Wenji;
Wu, Renyi;
Yin, Ran;
Sargsyan, Davit;
Raskin, Ilya;
Kong, Ah-Ng

Publication type:

Article

A Systems Pharmacology Model for Drug Delivery to Solid Tumors by Antibody-Drug Conjugates: Implications for Bystander Effects.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0390-2

By:

Burton, Jackson K.;
Bottino, Dean;
Secomb, Timothy W.

Publication type:

Article

Structural Characterization of the Aurora Kinase B "DFG-flip" Using Metadynamics.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0399-6

By:

Lakkaniga, Naga Rajiv;
Balasubramaniam, Meenakshisundaram;
Zhang, Shuxing;
Frett, Brendan;
Li, Hong-yu

Publication type:

Article

AAPS Workshop Report on ICH M10.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0398-7

By:

Booth, Brian;
Vazvaei, Faye;
Fluhler, Eric;
Myler, Heather;
Woolf, Eric

Publication type:

Article

Mechanistic Deconvolution of Oral Absorption Model with Dynamic Gastrointestinal Fluid to Predict Regional Rate and Extent of GI Drug Dissolution.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0385-z

By:

Yu, Alex;
Koenigsknecht, Mark J.;
Hens, Bart;
Baker, Jason R.;
Wen, Bo;
Jackson, Trachette L.;
Pai, Manjunath P.;
Hasler, William;
Amidon, Gordon L.;
Sun, Duxin

Publication type:

Article

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0384-0

By:

Mathaes, Roman;
Narhi, Linda;
Hawe, Andrea;
Matter, Anja;
Bechtold-Peters, Karoline;
Kenrick, Sophia;
Kar, Sambit;
Laskina, Olga;
Carpenter, John;
Cavicchi, Richard;
Koepf, Ellen;
Lewis, E. Neil;
De Silva, Rukman;
Ripple, Dean

Publication type:

Article

Biotransformation of the New Synthetic Cannabinoid with an Alkene, MDMB-4en-PINACA, by Human Hepatocytes, Human Liver Microsomes, and Human Urine and Blood.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0381-3

By:

Watanabe, Shimpei;
Vikingsson, Svante;
Åstrand, Anna;
Gréen, Henrik;
Kronstrand, Robert

Publication type:

Article

Application of Item Response Theory to Model Disease Progression and Agomelatine Effect in Patients with Major Depressive Disorder.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0379-x

By:

Cerou, Marc;
Peigné, Sophie;
Comets, Emmanuelle;
Chenel, Marylore

Publication type:

Article

Analysis of the Regulatory Divergence of Comparative Dissolution Requirements for Post-Approval Manufacturing Changes of Modified Release Solid Oral Dosage Forms.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0383-1

By:

Langer, Connie;
Diaz, Dorys Argelia;
Van Alstine, Leslie;
Bandi, Nagesh;
Fitzgerald, Sarah;
Colgan, Stephen

Publication type:

Article

On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0380-4

By:

Statelova, Marina;
Goumas, Konstantinos;
Fotaki, Nikoletta;
Holm, René;
Symillides, Mira;
Reppas, Christos;
Vertzoni, Maria

Publication type:

Article

Reengineering of Albumin-Fused Cocaine Hydrolase CocH1 (TV-1380) to Prolong Its Biological Half-Life.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0377-z

By:

Cai, Yingting;
Zhou, Shuo;
Jin, Zhenyu;
Wei, Huimei;
Shang, Linyue;
Deng, Jing;
Zhan, Chang-Guo;
Zheng, Fang

Publication type:

Article