Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 4

Results: 23

Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00954-2

By:

Usdin, Maxime;
Quarmby, Valerie;
Zanghi, James;
Bernaards, Coen;
Liao, Laura;
Laxamana, Joel;
Wu, Benjamin;
Swanson, Steven;
Song, Yuan;
Siguenza, Patty

Publication type:

Article

Sample Size Determination and Study Design Impact on Dose-Scale Pharmacodynamic Bioequivalence: a Case Study Using Orlistat.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00951-5

By:

Xu, Lian;
Li, Sanwang;
Wu, Wei;
Cheng, Zeneng;
Xie, Feifan

Publication type:

Article

Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00950-6

By:

Volpe, Donna A.

Publication type:

Article

Effect of Physicochemical Properties on the Basic Drug-Acid-Polymer Interactions and Miscibility in PVA Based Orodispersible Films.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00949-z

By:

Liu, Jie;
Zhang, Yongguo;
Liu, Chao;
Fang, Liang

Publication type:

Article

Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00945-3

By:

Wang, Deyun;
Li, Jiayi;
Chen, Kang

Publication type:

Article

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

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00926-6

By:

Abend, Andreas;
Stippler, Erika;
Kühl, Nikos;
Externbrink, Anna;
Smith, Kieran Lewis;
Mann, James

Publication type:

Article

Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00956-0

By:

Yang, Ruwei;
Lin, Yaqi;
Chen, Kaifeng;
Huang, Jie;
Yang, Shuang;
Yao, An;
Yang, Xiaoyan;
Lei, Deqing;
Xiao, Jing;
Yang, Guoping;
Pei, Qi

Publication type:

Article

Neutralizing Antibody Sample Testing and Report Harmonization.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00955-1

By:

Jani, Darshana;
Gunsior, Michele;
Marsden, Robin;
Cowan, Kyra J.;
Irvin, Susan C.;
Hay, Laura Schild;
Ward, Bethany;
Armstrong, Luke;
Azadeh, Mitra;
Cao, Liching;
Carmean, Rebecca;
DelCarpini, Jason;
Dholakiya, Sanjay L.;
Hays, Amanda;
Hosback, Sarah;
Hu, Zheng;
Kulagina, Nadia;
Kumar, Seema;
Lai, Ching Ha;
Lichtfuss, Marit

Publication type:

Article

Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00952-4

By:

Kim, Min-Soo;
Hajducek, Dagmar M.;
Gilbert, James C.;
Iorio, Alfonso;
Jilma, Bernd;
Edginton, Andrea N.

Publication type:

Article

Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00947-1

By:

Boffel, Laura;
Van Mensel, Anskje;
Pauwels, Janne;
Den Hond, Elly;
Bessems, Jos;
Van Uytfanghe, Katleen;
Stove, Christophe P.

Publication type:

Article

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00943-5

By:

Dal-Ré, Rafael;
Mahillo-Fernández, Ignacio

Publication type:

Article

Nanosimilars: A Scientific or A Regulatory Debate?

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00942-6

By:

Demetzos, Costas

Publication type:

Article

The Influence of Various Freezing–thawing Methods of Skin on Drug Permeation and Skin Barrier Function.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00941-7

By:

Wang, Xinying;
Zhang, Yuanyuan;
Liang, Kaili;
Meng, Xue;
Ma, Chunyan;
Wang, Qing

Publication type:

Article

3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00940-8

By:

Berardinelli, Diletta;
Taoussi, Omayema;
Daziani, Gloria;
Tavoletta, Francesco;
Ricci, Giovanna;
Tronconi, Livio P.;
Adamowicz, Piotr;
Busardò, Francesco P.;
Carlier, Jeremy

Publication type:

Article

Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00939-1

By:

Kollipara, Sivacharan;
Chougule, Mahendra;
Boddu, Rajkumar;
Bhatia, Ashima;
Ahmed, Tausif

Publication type:

Article

Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00938-2

By:

Wang, Michael;
Heimbach, Tycho;
Zhu, Wei;
Wu, Di;
Reuter, Kevin G.;
Kesisoglou, Filippos

Publication type:

Article

Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00937-3

By:

Kopp, Anna;
Guan, Jiakun;
Johnston, Colette;
Vance, Steven;
Legg, James;
Galson-Holt, Laurie;
Thurber, Greg M.

Publication type:

Article

Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00936-4

By:

Nagaiah, Hari Prasath;
Periyakaruppan Murugesan, Priya Dharsini;
Ravindra Rupali, Chaughule Vrushali;
Shunmugiah, Karutha Pandian

Publication type:

Article

Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00935-5

By:

Kaspera, Rudiger;
Shitara, Yoshihisa

Publication type:

Article

Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00934-6

By:

Asiimwe, Innocent Gerald;
S'fiso Ndzamba, Bonginkosi;
Mouksassi, Samer;
Pillai, Goonaseelan;
Lombard, Aurelie;
Lang, Jennifer

Publication type:

Article

Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm.

Published in:

2024

By:

Guhl, Mélanie;
Bertrand, Julie;
Fayette, Lucie;
Mercier, François;
Comets, Emmanuelle

Publication type:

Correction Notice

Correction: Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS).

Published in:

2024

By:

Hendrickx, Niels;
Mentré, France;
Traschütz, Andreas;
Gagnon, Cynthia;
Schüle, Rebecca;
Synofzik, Matthis;
Comets, Emmanuelle

Publication type:

Correction Notice

Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00928-4

By:

Prybylski, John P.;
Wang, Yuchen;
Sahasrabudhe, Vaishali;
Purohit, Vivek

Publication type:

Article