Works matching IS 15507416 AND DT 2023 AND VI 25 AND IP 3

Results: 23

A Precise qNMR Method for the Rapid Quantification of Lot-to-Lot Variations in Multiple Quality Attributes of Pentosan Polysulfate Sodium.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00815-4

By:

Wang, Kai;
Dai, Weixiang;
Qian, Keduo;
Scott, Barbara;
Chen, Kang

Publication type:

Article

Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00814-5

By:

Gorovits, Boris;
Azadeh, Mitra;
Buchlis, George;
Fiscella, Michele;
Harrison, Travis;
Havert, Mike;
Janetzki, Sylvia;
Jawa, Vibha;
Long, Brian;
Mahnke, Yolanda D.;
McDermott, Andrew;
Milton, Mark;
Nelson, Robert;
Vettermann, Christian;
Wu, Bonnie

Publication type:

Article

Physiologically Based Pharmacokinetic Modeling to Characterize the Effect of Molecular Charge on Whole-Body Disposition of Monoclonal Antibodies.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00812-7

By:

Liu, Shufang;
Shah, Dhaval K.

Publication type:

Article

Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00816-3

By:

Balthasar, Joseph P.

Publication type:

Article

The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00813-6

By:

Gao, Zongming;
Smith, Anjanette

Publication type:

Article

Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us?

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00803-8

By:

Weiss, Michael;
Siegmund, Werner

Publication type:

Article

Quantitative Analysis of Gastrointestinal Water Dynamics by Means of a Physiologically Based Fluid Kinetic Model.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00809-2

By:

Suzuki, Satoru;
Inoue, Katsuhisa;
Tamai, Ikumi;
Shirasaka, Yoshiyuki

Publication type:

Article

Plasma Stability and Plasma Metabolite Concentration–Time Profiles of Oligo(Lactic Acid)<sub>8</sub>-Paclitaxel Prodrug Loaded Polymeric Micelles.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00807-4

By:

Repp, Lauren;
Skoczen, Sarah L.;
Rasoulianboroujeni, Morteza;
Stern, Stephan T.;
Kwon, Glen S.

Publication type:

Article

Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00805-6

By:

Dai, Yanshan;
Dong, Huijin;
Gleason, Carol;
Mora, Johanna;
Kolaitis, Gerry;
Balasubramanian, Nanda;
Surapaneni, Sekhar;
Kozhich, Alexander;
Jawa, Vibha

Publication type:

Article

A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological Target Hemoglobin With Positive Cooperative Binding

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00808-3

By:

Xu, Min;
An, Guohua

Publication type:

Article

Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00811-8

By:

Holm, René;
Lee, Robert W.;
Glassco, Joey;
DiFranco, Nicholas;
Bao, Quanying;
Burgess, Diane J.;
Lukacova, Viera;
Alidori, Simone

Publication type:

Article

Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00806-5

By:

Garlits, John;
McAfee, Sean;
Taylor, Jessica-Ann;
Shum, Enoch;
Yang, Qi;
Nunez, Emily;
Kameron, Kristina;
Fenech, Keilah;
Rodriguez, Jacqueline;
Torri, Albert;
Chen, Jihua;
Sumner, Giane;
Partridge, Michael A.

Publication type:

Article

The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work.

Published in:

2023

By:

Mora, Johanna R.;
Richards, Susan M.

Publication type:

Editorial

InVitro-InVivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00800-x

By:

Tess, David;
Chang, George C.;
Keefer, Christopher;
Carlo, Anthony;
Jones, Rhys;
Di, Li

Publication type:

Article

Development of Drug Release Model for Suspensions in ESCAR (Emulator of SubCutaneous Absorption and Release).

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00799-1

By:

Lou, Hao;
Hageman, Michael J.

Publication type:

Article

Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00798-2

By:

Zou, Peng

Publication type:

Article

Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00804-7

By:

Zou, Peng;
Vaidyanathan, Jayabharathi;
Tran, Doanh;
Raines, Kimberly;
Chatterjee, Parnali;
Madabushi, Rajanikanth;
Seo, Shirley K.

Publication type:

Article

Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1.

Published in:

2023

By:

Sánchez, Javier;
Nicolini, Valeria;
Fahrni, Linda;
Waldhauer, Inja;
Walz, Antje‑Christine;
Jamois, Candice;
Fowler, Stephen;
Simon, Silke;
Klein, Christian;
Umaña, Pablo;
Friberg, Lena E.;
Frances, Nicolas

Publication type:

Correction Notice

The Uses and Advantages of Kirchhoff's Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00801-w

By:

Benet, Leslie Z.;
Sodhi, Jasleen K.

Publication type:

Article

Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00795-5

By:

Abend, Andreas M.;
Hoffelder, Thomas;
Cohen, Michael J.;
Van Alstine, Leslie;
Diaz, Dorys Argelia;
Fredro-Kumbaradzi, Emilija;
Reynolds, James;
Zheng, Yanbing;
Witkowski, Krista;
Heimbach, Tycho

Publication type:

Article

Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00794-6

By:

Mukherjee, Dwaipayan;
Chen, Mong-Jen;
Shao, Xi;
Ju, Tzuchi R.;
Shebley, Mohamad;
Marroum, Patrick

Publication type:

Article

Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00793-7

By:

Tsume, Yasuhiro;
Ashworth, Lee;
Bermejo, Marival;
Cheng, Joan;
Cicale, Vincent;
Dressman, Jennifer;
Fushimi, Masahiro;
Gonzalez-Alvarez, Isabel;
Guo, Yiwang;
Jankovsky, Corinne;
Lu, Xujin;
Matsui, Kazuki;
Patel, Sanjaykumar;
Sanderson, Natalie;
Sun, Changquan Calvin;
Thakral, Naveen K.;
Yamane, Miki;
Zöller, Laurin

Publication type:

Article

Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00792-8

By:

Purohit, Vivek;
Huh, Yeamin;
Wojciechowski, Jessica;
Plotka, Anna;
Salts, Stephanie;
Antinew, Jeremias;
Dimitrova, Angela;
Nicholas, Timothy

Publication type:

Article