Works matching IS 15507416 AND DT 2016 AND VI 18 AND IP 6

Results: 25

Physiologically Based Absorption Modeling to Design Extended-Release Clinical Products for an Ester Prodrug.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1424, doi. 10.1208/s12248-016-9950-x

By:

Ding, Xuan;
Day, Jeffrey;
Sperry, David

Publication type:

Article

An Agent-Based Approach to Dynamically Represent the Pharmacokinetic Properties of Baicalein.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1475, doi. 10.1208/s12248-016-9955-5

By:

Zhu, Xiao;
Deng, Jianyuan;
Zuo, Zhong;
Lam, Tai

Publication type:

Article

Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1439, doi. 10.1208/s12248-016-9948-4

By:

Jawa, Vibha;
Joubert, Marisa;
Zhang, Qingchun;
Deshpande, Meghana;
Hapuarachchi, Suminda;
Hall, Michael;
Flynn, Gregory

Publication type:

Article

Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers.

Published in:

2016

By:

Arnold, Mark;
Booth, Brian;
King, Lindsay;
Ray, Chad

Publication type:

Report

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1335, doi. 10.1208/s12248-016-9954-6

By:

Wu, Bonnie;
Chung, Shan;
Jiang, Xu-Rong;
McNally, Jim;
Pedras-Vasconcelos, Joao;
Pillutla, Renuka;
White, Joleen;
Xu, Yuanxin;
Gupta, Shalini

Publication type:

Article

Erratum to: Does the Recent Growth of Aquaculture Create Antibiotic Resistance Threats Different from those Associated with Land Animal Production in Agriculture?

Published in:

2016

By:

Done, Hansa;
Venkatesan, Arjun;
Halden, Rolf

Publication type:

Erratum

Erratum to: Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin.

Published in:

2016

By:

Martinez, Marilyn;
Mistry, Bipin;
Lukacova, Viera;
Polli, James;
Hoag, Stephen;
Dowling, Thomas;
Kona, Ravikanth;
Fahmy, Raafat

Publication type:

Erratum

The Dual Role of Lipids of the Lipoproteins in Trumenba, a Self-Adjuvanting Vaccine Against Meningococcal Meningitis B Disease.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1562, doi. 10.1208/s12248-016-9979-x

By:

Luo, Yin;
Friese, Olga;
Runnels, Herbert;
Khandke, Lakshmi;
Zlotnick, Gary;
Aulabaugh, Ann;
Gore, Thomas;
Vidunas, Eugene;
Raso, Stephen;
Novikova, Elena;
Byrne, Emilia;
Schlittler, Michael;
Stano, Donald;
Dufield, Robert;
Kumar, Sandeep;
Anderson, Annaliesa;
Jansen, Kathrin;
Rouse, Jason

Publication type:

Article

A Physiologically Based Pharmacokinetic Model for Ganciclovir and Its Prodrug Valganciclovir in Adults and Children.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1453, doi. 10.1208/s12248-016-9956-4

By:

Lukacova, V.;
Goelzer, P.;
Reddy, M.;
Greig, G.;
Reigner, B.;
Parrott, N.

Publication type:

Article

Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1464, doi. 10.1208/s12248-016-9957-3

By:

Parrott, Neil;
Yu, Li;
Takano, Ryusuke;
Nakamura, Mikiko;
Morcos, Peter

Publication type:

Article

Nanomedicines: From Bench to Bedside and Beyond.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1373, doi. 10.1208/s12248-016-9961-7

By:

Havel, Henry;
Finch, Gregory;
Strode, Pamela;
Wolfgang, Marc;
Zale, Stephen;
Bobe, Iulian;
Youssoufian, Hagop;
Peterson, Matthew;
Liu, Maggie

Publication type:

Article

Challenges and Opportunities with Non-CYP Enzymes Aldehyde Oxidase, Carboxylesterase, and UDP-Glucuronosyltransferase: Focus on Reaction Phenotyping and Prediction of Human Clearance.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1391, doi. 10.1208/s12248-016-9962-6

By:

Argikar, Upendra;
Potter, Philip;
Hutzler, J.;
Marathe, Punit

Publication type:

Article

Metabolism of Carfentanil, an Ultra-Potent Opioid, in Human Liver Microsomes and Human Hepatocytes by High-Resolution Mass Spectrometry.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1489, doi. 10.1208/s12248-016-9963-5

By:

Feasel, Michael;
Wohlfarth, Ariane;
Nilles, John;
Pang, Shaokun;
Kristovich, Robert;
Huestis, Marilyn

Publication type:

Article

Development of a Novel Simplified PBPK Absorption Model to Explain the Higher Relative Bioavailability of the OROS® Formulation of Oxybutynin.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1532, doi. 10.1208/s12248-016-9965-3

By:

Olivares-Morales, Andrés;
Ghosh, Avijit;
Aarons, Leon;
Rostami-Hodjegan, Amin

Publication type:

Article

Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1500, doi. 10.1208/s12248-016-9964-4

By:

Chow, Edwin;
Talattof, Arjang;
Tsakalozou, Eleftheria;
Fan, Jianghong;
Zhao, Liang;
Zhang, Xinyuan

Publication type:

Article

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1379, doi. 10.1208/s12248-016-9966-2

By:

Suarez-Sharp, Sandra;
Li, Min;
Duan, John;
Shah, Heta;
Seo, Paul

Publication type:

Article

Nanomedicines in the EU-Regulatory Overview.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1576, doi. 10.1208/s12248-016-9967-1

By:

Pita, Ruben;
Ehmann, Falk;
Papaluca, Marisa

Publication type:

Article

A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1354, doi. 10.1208/s12248-016-9969-z

By:

Troiano, Greg;
Nolan, Jim;
Parsons, Donald;
Van Geen Hoven, Christina;
Zale, Stephen

Publication type:

Article

Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1351, doi. 10.1208/s12248-016-9970-6

By:

Havel, Henry

Publication type:

Article

Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1550, doi. 10.1208/s12248-016-9971-5

By:

Mangas-Sanjuan, Victor;
Colon-Useche, Sarin;
Gonzalez-Alvarez, Isabel;
Bermejo, Marival;
Garcia-Arieta, Alfredo

Publication type:

Article

Utilizing In Vitro Dissolution-Permeation Chamber for the Quantitative Prediction of pH-Dependent Drug-Drug Interactions with Acid-Reducing Agents: a Comparison with Physiologically Based Pharmacokinetic Modeling.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1512, doi. 10.1208/s12248-016-9972-4

By:

Zhu, Andy;
Ho, Ming-Chih;
Gemski, Christopher;
Chuang, Bei-Ching;
Liao, Mingxiang;
Xia, Cindy

Publication type:

Article

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1406, doi. 10.1208/s12248-016-9974-2

By:

Li, Min;
Sander, Sanna;
Duan, John;
Rosencrance, Susan;
Miksinski, Sarah;
Yu, Lawrence;
Seo, Paul;
Rege, Bhagwant

Publication type:

Article

P-glycoprotein Function in the Rodent Brain Displays a Daily Rhythm, a Quantitative In Vivo PET Study.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1524, doi. 10.1208/s12248-016-9973-3

By:

Savolainen, Heli;
Meerlo, Peter;
Elsinga, Philip;
Windhorst, Albert;
Dierckx, Rudi;
Colabufo, Nicola;
van Waarde, Aren;
Luurtsema, Gert

Publication type:

Article

Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations.

Published in:

AAPS Journal, 2016, v. 18, n. 6, p. 1418, doi. 10.1208/s12248-016-9976-0

By:

Henry, Teresa;
Penn, Lara;
Conerty, Jason;
Wright, Francesca;
Gorman, Gregory;
Pack, Brian

Publication type:

Article

Erratum to: Computational Advances for the Development of Allosteric Modulators and Bitopic Ligands in G Protein-Coupled Receptors.

Published in:

2016

By:

Feng, Zhiwei;
Hu, Guanxing;
Ma, Shifan;
Xie, Xiang-Qun

Publication type:

Erratum