Works matching IS 15507416 AND DT 2023 AND VI 25 AND IP 5

Results: 18

A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00857-8

By:

Niemuth, Nancy A.;
Triplett, Cheryl A.;
Anderson, Michael S.;
Sankovich, Karen A.;
Rudge Jr., Thomas L.

Publication type:

Article

Phase-appropriate Application of Process Analytical Technology for Early Pharmaceutical Development of Oral Solid Dosage Forms—the Case Study of Uniformity Screening of Dosage Units and Blends.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00854-x

By:

Razvi, Sayyeda Zeenat;
Ma, Shengli;
Zhong, Qiqing;
Muliadi, Ariel;
Shi, Zhenqi

Publication type:

Article

Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00853-y

By:

Adachi, Asahi;
Yamashita, Tomoki;
Kanaya, Shigehiko;
Kosugi, Yohei

Publication type:

Article

Human Brain Penetration Prediction Using Scaling Approach from Animal Machine Learning Models.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00850-1

By:

Liu, Siyu;
Kosugi, Yohei

Publication type:

Article

Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00852-z

By:

Haltaufderhyde, Kirk;
Roberts, Brian J.;
Khan, Sundos;
Terry, Frances;
Boyle, Christine M.;
McAllister, Mitchell;
Martin, William;
Rosenberg, Amy;
De Groot, Anne S.

Publication type:

Article

Nature vs. Manmade: Comparing Exosomes and Liposomes for Traumatic Brain Injury.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00849-8

By:

Hennigan, Kate;
Lavik, Erin

Publication type:

Article

Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00848-9

By:

Shim, Jeongsup;
Chen, Jessica;
Carrasco-Triguero, Montserrat;
Fischer, Saloumeh K.

Publication type:

Article

Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00847-w

By:

Donley, Jean;
Jani, Darshana;
Zhu, Tong;
Xiang, Yuhong;
Gorovits, Boris;
Arkin, Steven

Publication type:

Article

Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00846-x

By:

McCush, Fred;
Wang, Ellen;
Yunis, Carla;
Schwartz, Pamela;
Baltrukonis, Daniel

Publication type:

Article

Targeting Macrophages for Tumor Therapy.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00845-y

By:

Wang, Yixin;
Barrett, Allie;
Hu, Quanyin

Publication type:

Article

Gastrointestinal Delivery of an mRNA Vaccine Using Immunostimulatory Polymeric Nanoparticles.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00844-z

By:

Kim, Hyunjoon;
Kirtane, Ameya R.;
Kim, Na Yoon;
Rajesh, Netra Unni;
Tang, Chaoyang;
Ishida, Keiko;
Hayward, Alison M.;
Langer, Robert;
Traverso, Giovanni

Publication type:

Article

Real-Time Tracking of In Situ-Forming Alginate Hydrogel by Contrast-Enhanced Computed Tomography.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00843-0

By:

Guirguis, Natalie;
Zellagui, Yanis;
Matoori, Simon

Publication type:

Article

PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00842-1

By:

Kavita, Uma;
Sun, Kefeng;
Braun, Manuela;
Lembke, Wibke;
Mody, Hardik;
Kamerud, John;
Yang, Tong-Yuan;
Braun, Inka V.;
Fang, Xiaodong;
Gao, Wei;
Gupta, Swati;
Hofer, Magdalena;
Liao, Michael Z.;
Loo, LiNa;
McBlane, Fraser;
Menochet, Karelle;
Stubenrauch, Kay-Gunnar;
Upreti, Vijay V.;
Vigil, Adam;
Wiethoff, Christopher M.

Publication type:

Article

Development of a Cell-based Neutralizing Antibody Assay for Zinpentraxin Alfa: Challenges and Mitigation Strategies.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00841-2

By:

Yin, Zhaojun;
Guerrero, Joyce;
Melendez, Rachel;
Andrews, Ben;
Peng, Kun

Publication type:

Article

Stochastic Differential Equation-based Mixed Effects Model of the Fluid Volume in the Fasted Stomach in Healthy Adult Human.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00840-3

By:

Wang, Kai;
Marciani, Luca;
Amidon, Gordon L.;
Smith, David E.;
Sun, Duxin

Publication type:

Article

Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro,In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00837-y

By:

Ahmed, Tausif;
Kollipara, Sivacharan;
Boddu, Rajkumar;
Bhattiprolu, Adithya Karthik

Publication type:

Article

Comparison of Analytical Procedures in Method Transfer and Bridging Experiments.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00834-1

By:

Burdick, Richard K.

Publication type:

Article

Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir.

Published in:

AAPS Journal, 2023, v. 25, n. 5, p. 1, doi. 10.1208/s12248-023-00832-3

By:

Gerhart, Jacqueline;
Draica, Florin;
Benigno, Michael;
Atkinson, Jo;
Reimbaeva, Maya;
Francis, Domenick;
Baillon-Plot, Nathalie;
Sidhu, Gurinder Singh;
Damle, Bharat D.

Publication type:

Article