Works matching IS 15507416 AND DT 2020 AND VI 22 AND IP 6

Results: 26

Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. 1, doi. 10.1208/s12248-020-00522-4

By:

Statelova, Marina;
Holm, René;
Fotaki, Nikoletta;
Reppas, Christos;
Vertzoni, Maria

Publication type:

Article

Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. 1, doi. 10.1208/s12248-020-00530-4

By:

Gorovits, Boris

Publication type:

Article

Monoclonal Antibody Reagent Stability and Expiry Recommendation Combining Experimental Data with Mathematical Modeling.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. 1, doi. 10.1208/s12248-020-00521-5

By:

Fink, Malorie;
Cannon, Erin Marie;
Hofmann, Carl;
Patel, Nisarg;
Pauley, Cindy;
Troutman, Matthew;
Rustandi, Richard R.;
Shank-Retzlaff, Mary;
Loughney, John;
Verch, Thorsten

Publication type:

Article

Predicting Chemotherapy-Induced Neutropenia and Granulocyte Colony–Stimulating Factor Response Using Model-Based In Vitro to Clinical Translation.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. 1, doi. 10.1208/s12248-020-00529-x

By:

Chen, Wenbo;
Boras, Britton;
Sung, Tae;
Hu, Wenyue;
Spilker, Mary E.;
D’Argenio, David Z.

Publication type:

Article

Correction to: In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes.

Published in:

2020

By:

Docci, Luca;
Klammers, Florian;
Ekiciler, Aynur;
Molitor, Birgit;
Umehara, Kenichi;
Walter, Isabelle;
Krähenbühl, Stephan;
Parrott, Neil;
Fowler, Stephen

Publication type:

Correction Notice

Women in the Pharmaceutical Sciences: Honoring Our Pioneers.

Published in:

2020

By:

Lavelle, Amy;
Morris, Marilyn E.

Publication type:

Editorial

Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00524-2

By:

Wickremsinhe, Enaksha R;
Ji, Qin C.;
Gleason, Carol R.;
Anderson, Melanie;
Booth, Brian P.

Publication type:

Article

Simulation Informed Design and Performance of In Vitro Bioequivalence Trials for Particle Size Distributions.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00520-6

By:

Ganley, William J.;
Shur, Jagdeep;
Price, Robert

Publication type:

Article

Statistical Considerations in Assessing In Vivo Adhesion with Transdermal and Topical Delivery Systems for New Drug Applications.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00519-z

By:

Wang, Chao;
Strasinger, Caroline;
Shen, Meiyu;
Tsong, Yi

Publication type:

Article

Bioanalytical Challenges in Support of Complex Modalities of Antibody-Based Therapeutics.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00517-1

By:

Zhu, Liang;
Glick, Jim;
Flarakos, Jimmy

Publication type:

Article

Role of HIV and Antiretroviral Therapy on the Expression of Placental Transporters in Women with HIV.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00516-2

By:

Kojovic, Dea;
Ghoneim, Ragia H.;
Serghides, Lena;
Piquette-Miller, Micheline

Publication type:

Article

Science and Risked-Based Stability Testing Strategies—a Test Case on the Global Implementation and Regulatory Reception.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00515-3

By:

Diaz, Dorys Argelia;
Lynch, Michael;
McMahon, Megan;
Oblessuc, Raquel;
Colgan, Stephen T.

Publication type:

Article

Identification and Utilization of Biomarkers to Predict Response to Immune Checkpoint Inhibitors.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00514-4

By:

Gjoerup, Ole;
Brown, Charlotte A.;
Ross, Jeffrey S.;
Huang, Richard S. P.;
Schrock, Alexa;
Creeden, James;
Fabrizio, David;
Tolba, Khaled

Publication type:

Article

Construction and Verification of Physiologically Based Pharmacokinetic Models for Four Drugs Majorly Cleared by Glucuronidation: Lorazepam, Oxazepam, Naloxone, and Zidovudine.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00513-5

By:

Docci, Luca;
Umehara, Kenichi;
Krähenbühl, Stephan;
Fowler, Stephen;
Parrott, Neil

Publication type:

Article

Cell-to-Medium Concentration Ratio Overshoot in the Uptake of Statins by Human Hepatocytes in Suspension, but Not in Monolayer: Kinetic Analysis Suggesting a Partial Loss of Functional OATP1Bs.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00512-6

By:

Lee, Wooin;
Koyama, Satoshi;
Morita, Kiyoe;
Kiriake, Aya;
Kikuchi, Ryota;
Chu, Xiaoyan;
Lee, Nora;
Scialis, Renato J.;
Shen, Hong;
Kimoto, Emi;
Tremaine, Larry;
Ishiguro, Naoki;
Lotz, Ralf;
Maeda, Kazuya;
Kusuhara, Hiroyuki;
Sugiyama, Yuichi

Publication type:

Article

Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00511-7

By:

Gajewska, Monika;
Blumenstein, Lars;
Kourentas, Alexandros;
Mueller-Zsigmondy, Martin;
Lorenzo, Sebastien;
Sinn, Angela;
Velinova, Maria;
Heimbach, Tycho

Publication type:

Article

Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00510-8

By:

Bowsher, Ronald R.;
Devanarayan, Viswanath

Publication type:

Article

Biliary Excretion–Mediated Food Effects and Prediction.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00509-1

By:

Xiao, Jingcheng;
Tran, Doanh;
Zhang, Xinyuan;
Zhang, Tao;
Seo, Shirley;
Zhu, Haojie;
Zou, Peng

Publication type:

Article

Simultaneous Ivabradine Parent-Metabolite PBPK/PD Modelling Using a Bayesian Estimation Method.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00502-8

By:

Lang, Jennifer;
Vincent, Ludwig;
Chenel, Marylore;
Ogungbenro, Kayode;
Galetin, Aleksandra

Publication type:

Article

In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00482-9

By:

Docci, Luca;
Klammers, Florian;
Ekiciler, Aynur;
Molitor, Birgit;
Umehara, Kenichi;
Walter, Isabelle;
Krähenbühl, Stephan;
Parrott, Neil;
Fowler, Stephen

Publication type:

Article

Pulmonary administration of remdesivir in the treatment of COVID-19.

Published in:

2020

By:

Rasmussen, Henrik Berg;
Hansen, Peter Riis;
Taboureau, Olivier;
Thomsen, Ragnar;
Jürgens, Gesche

Publication type:

Letter

Bioavailability Enhancement and Food Effect Elimination of Abiraterone Acetate by Encapsulation in Surfactant-Enriched Oil Marbles.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00505-5

By:

Boleslavská, Tereza;
Rychecký, Ondřej;
Krov, Martin;
Žvátora, Pavel;
Dammer, Ondřej;
Beránek, Josef;
Kozlík, Petr;
Křížek, Tomáš;
Hořínková, Jana;
Ryšánek, Pavel;
Roušarová, Jaroslava;
Canová, Nikolina Kutinová;
Šíma, Martin;
Slanař, Ondřej;
Štěpánek, František

Publication type:

Article

Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00504-6

By:

Statelova, Marina;
Holm, René;
Fotaki, Nikoletta;
Reppas, Christos;
Vertzoni, Maria

Publication type:

Article

Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00508-2

By:

Riedmaier, Arian Emami;
DeMent, Kevin;
Huckle, James;
Bransford, Phil;
Stillhart, Cordula;
Lloyd, Richard;
Alluri, Ravindra;
Basu, Sumit;
Chen, Yuan;
Dhamankar, Varsha;
Dodd, Stephanie;
Kulkarni, Priyanka;
Olivares-Morales, Andrés;
Peng, Chi-Chi;
Pepin, Xavier;
Ren, Xiaojun;
Tran, Thuy;
Tistaert, Christophe;
Heimbach, Tycho;
Kesisoglou, Filippos

Publication type:

Article

New Model–Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00507-3

By:

Loingeville, Florence;
Bertrand, Julie;
Nguyen, Thu Thuy;
Sharan, Satish;
Feng, Kairui;
Sun, Wanjie;
Han, Jing;
Grosser, Stella;
Zhao, Liang;
Fang, Lanyan;
Möllenhoff, Kathrin;
Dette, Holger;
Mentré, France

Publication type:

Article

Incorporating Pharmacological Target-Mediated Drug Disposition (TMDD) in a Whole-Body Physiologically Based Pharmacokinetic (PBPK) Model of Linagliptin in Rat and Scale-up to Human.

Published in:

AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00481-w

By:

Wu, Nan;
An, Guohua

Publication type:

Article