Works matching IS 15507416 AND DT 2020 AND VI 22 AND IP 5

Results: 28

A Three-Treatment Two-Stage Design for Selection of a Candidate Formulation and Subsequent Demonstration of Bioequivalence.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00492-7

By:

Fuglsang, Anders

Publication type:

Article

Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance.

Published in:

2020

By:

Hu, Meng;
Jiang, Xiaohui;
Absar, Mohammad;
Choi, Stephanie;
Kozak, Darby;
Shen, Meiyu;
Weng, Yu-Ting;
Zhao, Liang;
Lionberger, Robert

Publication type:

Correction Notice

Investigating the Theoretical Basis for In Vitro–In Vivo Extrapolation (IVIVE) in Predicting Drug Metabolic Clearance and Proposing Future Experimental Pathways.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00501-9

By:

Benet, Leslie Z.;
Sodhi, Jasleen K.

Publication type:

Article

Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00486-5

By:

Bodin, Jonathan;
Liandrat, Stéphanie;
Kocevar, Gabriel;
Petitcolas, Céline

Publication type:

Article

A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00503-7

By:

Dolton, Michael J.;
Chiang, Po-Chang;
Ma, Fang;
Jin, Jin Y.;
Chen, Yuan

Publication type:

Article

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00500-w

By:

Lyauk, Yassine Kamal;
Jonker, Daniël M.;
Lund, Trine Meldgaard;
Hooker, Andrew C.;
Karlsson, Mats O.

Publication type:

Article

HIV-1 Sanctuary Sites—the Role of Membrane-Associated Drug Transporters and Drug Metabolic Enzymes.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00498-1

By:

Whyte-Allman, Sana-Kay;
Bendayan, Reina

Publication type:

Article

Inter-compound and Intra-compound Global Sensitivity Analysis of a Physiological Model for Pulmonary Absorption of Inhaled Compounds.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00499-0

By:

Melillo, Nicola;
Grandoni, Silvia;
Cesari, Nicola;
Brogin, Giandomenico;
Puccini, Paola;
Magni, Paolo

Publication type:

Article

Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00497-2

By:

Partridge, Michael A.;
Karayusuf, Elif Kabuloglu;
Shyu, Gary;
Georgaros, Camille;
Torri, Albert;
Sumner, Giane

Publication type:

Article

Pitfalls in Predicting Hepatobiliary Drug Transport Using Human Sandwich-Cultured Hepatocytes.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00496-3

By:

Kumar, Vineet;
Li, Cindy Yanfei;
Ishida, Kazuya;
Kis, Emese;
Gáborik, Zsuzsanna;
Unadkat, Jashvant D.

Publication type:

Article

Challenge-Enabled Machine Learning to Drug-Response Prediction.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00494-5

By:

Wang, Ziyan;
Li, Hongyang;
Carpenter, Christopher;
Guan, Yuanfang

Publication type:

Article

Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00495-4

By:

Loisios-Konstantinidis, Ioannis;
Hens, Bart;
Mitra, Amitava;
Kim, Sarah;
Chiann, Chang;
Cristofoletti, Rodrigo

Publication type:

Article

Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00493-6

By:

Miao, Lei;
Mousa, Youssef M.;
Zhao, Liang;
Raines, Kimberly;
Seo, Paul;
Wu, Fang

Publication type:

Article

Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00480-x

By:

Liu, Dan;
Li, Linzhong;
Rostami-Hodjegan, Amin;
Bois, Frederic Y.;
Jamei, Masoud

Publication type:

Article

Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00491-8

By:

Wickramarachchi, Dilki;
Steeno, Gregory;
You, Zhiping;
Shaik, Saleem;
Lepsy, Christopher;
Xue, Li

Publication type:

Article

PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00489-2

By:

Xie, Feifan;
Van Bocxlaer, Jan;
Colin, Pieter;
Carlier, Charlotte;
Van Kerschaver, Olivier;
Weerts, Joseph;
Denys, Hannelore;
Tummers, Philippe;
Willaert, Wouter;
Ceelen, Wim;
Vermeulen, An

Publication type:

Article

Association Between Vomiting and QT Hysteresis: Data from a TQT Study with the Endothelin A Receptor Antagonist Clazosentan.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00485-6

By:

Juif, Pierre-Eric;
Dingemanse, Jasper;
Voors-Pette, Christine;
Ufer, Mike

Publication type:

Article

Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00484-7

By:

Lyauk, Yassine Kamal;
Lund, Trine Meldgaard;
Hooker, Andrew C.;
Karlsson, Mats O.;
Jonker, Daniël M.

Publication type:

Article

The Effects of Dose Volume and Excipient Dose on Luminal Concentration and Oral Drug Absorption.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00490-9

By:

Aungst, Bruce J.

Publication type:

Article

Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00488-3

By:

Zhu, Peijuan;
Hsu, Chyi-Hung;
Hu, Chuanpu;
Wong, Peggy;
Sy, Sherwin K. B.;
Nandy, Partha;
Zhou, Honghui

Publication type:

Article

Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00487-4

By:

Alleyn, Matthew;
Closson, Kristin;
Gentile, Adam;
Gulbis, Nathan;
Taylor, Christopher;
Rhyne, Paul

Publication type:

Article

Correction to: Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Additional Benefit.

Published in:

2020

By:

Sun, Duxin

Publication type:

Correction Notice

Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00478-5

By:

Hu, Chuanpu;
Zhou, Honghui;
Sharma, Amarnath

Publication type:

Article

A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00477-6

By:

Rhieu, Steve Y.;
Anderson, David D.;
Janoria, Kumar

Publication type:

Article

Capturing the Magic Bullet: Pharmacokinetic Principles and Modeling of Antibody-Drug Conjugates.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00475-8

By:

Zuo, Peiying

Publication type:

Article

Discovery of a Highly Selective Sigma-2 Receptor Ligand, 1-(4-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)butyl)-3-methyl-1H-benzo[d]imidazol-2(3H)-one (CM398), with Drug-Like Properties and Antinociceptive Effects In Vivo.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00472-x

By:

Intagliata, Sebastiano;
Sharma, Abhisheak;
King, Tamara I.;
Mesangeau, Christophe;
Seminerio, Michael;
Chin, Frederick T.;
Wilson, Lisa L.;
Matsumoto, Rae R.;
McLaughlin, Jay P.;
Avery, Bonnie A.;
McCurdy, Christopher R.

Publication type:

Article

Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00470-z

By:

Selen, Arzu;
Müllertz, Anette;
Kesisoglou, Filippos;
Ho, Rodney J. Y.;
Cook, Jack A.;
Dickinson, Paul A.;
Flanagan, Talia

Publication type:

Article

The Necessity of Using Changes in Absorption Time to Implicate Intestinal Transporter Involvement in Oral Drug-Drug Interactions.

Published in:

AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00469-6

By:

Sodhi, Jasleen K.;
Benet, Leslie Z.

Publication type:

Article