Works matching IS 15507416 AND DT 2020 AND VI 22 AND IP 2

Results: 39

Physiologically Based Pharmacokinetic Modeling and Tissue Distribution Characteristics of SHetA2 in Tumor-Bearing Mice.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0421-z

By:

Sharma, Ankur;
Li, Mengjie;
Thavathiru, Elangovan;
Ibrahim, Mariam;
Garcia-Contreras, Lucila;
Benbrook, Doris M;
Woo, Sukyung

Publication type:

Article

Bayesian Individual Dynamic Predictions with Uncertainty of Longitudinal Biomarkers and Risks of Survival Events in a Joint Modelling Framework: a Comparison Between Stan, Monolix, and NONMEM.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0388-9

By:

Riglet, François;
Mentre, France;
Veyrat-Follet, Christine;
Bertrand, Julie

Publication type:

Article

Mechanistic Pharmacokinetic/Pharmacodynamic Model of Sunitinib and Dopamine in MCF-7/Adr Xenografts: Linking Cellular Heterogeneity to Tumour Burden.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0428-5

By:

Wang, Siyuan;
Zhu, Xiao;
Han, Mengyi;
Hao, Fangran;
Lu, Wei;
Zhou, Tianyan

Publication type:

Article

A Microfluidic Perfusion Platform for In Vitro Analysis of Drug Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0430-y

By:

Guerrero, Yadir A.;
Desai, Diti;
Sullivan, Connor;
Kindt, Erick;
Spilker, Mary E.;
Maurer, Tristan S.;
Solomon, Deepak E.;
Bartlett, Derek W.

Publication type:

Article

Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0431-x

By:

Luong, Michael;
Wang, Ying;
Berasi, Stephen P.;
Buhlmann, Janet E.;
Yang, Hongying;
Gorovits, Boris

Publication type:

Article

Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-00438-z

By:

Wang, Bonnie;
Wang, Linna;
Batog, Alicja;
Brodie, Thomas;
Ramaiah, Lila;
Chadwick, Kristina D.;
Su, Ting;
Mangipudy, Raja;
Pilutla, Renuka C.;
Ji, Qin C.

Publication type:

Article

Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0432-9

By:

Martir, Joana;
Flanagan, Talia;
Mann, James;
Fotaki, Nikoletta

Publication type:

Article

Investigations of Piperazine Derivatives as Intestinal Permeation Enhancers in Isolated Rat Intestinal Tissue Mucosae.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0416-9

By:

Stuettgen, V.;
Brayden, D. J.

Publication type:

Article

Dose Correction for a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model with a Multiple Intravenous Dosing Regimens.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0410-2

By:

Yan, Xiaoyu;
Ruixo, Juan Jose Perez;
Krzyzanski, Wojciech

Publication type:

Article

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0433-8

By:

Hu, Ping;
Wang, Jie;
Florian, Jeffery;
Shatzer, Katherine;
Stevens, Alan M.;
Gertz, Jacqueline;
Ji, Ping;
Huang, Shiew Mei;
Zineh, Issam;
Wang, Yow-Ming C.

Publication type:

Article

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study—Hypromellose (HPMC)

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0411-1

By:

Zarmpi, P.;
Flanagan, T.;
Meehan, E.;
Mann, J.;
Fotaki, N.

Publication type:

Article

Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0427-6

By:

Schütz, Helmut;
Labes, Detlew;
Tomashevskiy, Michael;
la Parra, Mario González-de;
Shitova, Anastasia;
Fuglsang, Anders

Publication type:

Article

Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.

Published in:

2020

By:

Gorovits, Boris;
Fiscella, Michele;
Havert, Mike;
Koren, Eugen;
Long, Brian;
Milton, Mark;
Purushothama, Shobha

Publication type:

Correction Notice

Model Averaging in Viral Dynamic Models.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0426-7

By:

Gonçalves, Antonio;
Mentré, France;
Lemenuel-Diot, Annabelle;
Guedj, Jérémie

Publication type:

Article

Global Sensitivity Analysis of the Rodgers and Rowland Model for Prediction of Tissue: Plasma Partitioning Coefficients: Assessment of the Key Physiological and Physicochemical Factors That Determine Small-Molecule Tissue Distribution.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0418-7

By:

Yau, Estelle;
Olivares-Morales, Andrés;
Gertz, Michael;
Parrott, Neil;
Darwich, Adam S.;
Aarons, Leon;
Ogungbenro, Kayode

Publication type:

Article

Application of Reticulocyte-Based Estimation of Red Blood Cell Lifespan in Anemia Management of End-Stage Renal Disease Patients.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0424-9

By:

Nguyen, Ly Minh;
Meaney, Calvin J.;
Rao, Gauri G.;
Panesar, Mandip;
Krzyzanski, Wojciech

Publication type:

Article

Physiologically Based Pharmacokinetic Modeling and Simulation of Sunitinib in Pediatrics.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0423-x

By:

Yu, Yanke;
DuBois, Steven G.;
Wetmore, Cynthia;
Khosravan, Reza

Publication type:

Article

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0422-y

By:

Price, Robert;
Shur, Jagdeep;
Ganley, William;
Farias, Gonçalo;
Fotaki, Nikoletta;
Conti, Denise S.;
Delvadia, Renishkumar;
Absar, Mohammad;
Saluja, Bhawana;
Lee, Sau

Publication type:

Article

Immunogenicity Risk Assessment for PEGylated Therapeutics.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0420-0

By:

Mora, Johanna R.;
White, Joleen T.;
DeWall, Stephen L.

Publication type:

Article

Quantification of T Cell Binding Polyclonal Rabbit Anti-thymocyte Globulin in Human Plasma with Liquid Chromatography Tandem-Mass Spectrometry.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0419-6

By:

Amrani, Mohsin El;
Admiraal, Rick;
Willaert, Lobke;
Ebskamp-van Raaij, Lysette J. C.;
Lacna, Amelia M.;
Hack, C. Erik;
Huitema, Alwin D. R.;
Nierkens, Stefan;
van Maarseveen, Erik M.

Publication type:

Article

The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0402-2

By:

Yang, Wenzhan;
Gadgil, Prajakta;
Krishnamurthy, Venkata R.;
Landis, Margaret;
Mallick, Pankajini;
Patel, Dipal;
Patel, Phenil J.;
Reid, Darren L.;
Sanchez-Felix, Manuel

Publication type:

Article

Selection of In Vivo Predictive Dissolution Media Using Drug Substance and Physiological Properties.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0417-8

By:

Mudie, Deanna M.;
Samiei, Nasim;
Marshall, Derrick J.;
Amidon, Gregory E.;
Bergström, Christel A.S.

Publication type:

Article

Quantitative Assessment of Pulmonary Targeting of Inhaled Corticosteroids Using Ex Vivo Receptor Binding Studies.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0404-0

By:

Shao, Jie;
Talton, James;
Wang, Yaning;
Winner, Lawrence;
Hochhaus, Guenther

Publication type:

Article

Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 Diabetes.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0401-3

By:

Williams, Jason H.;
Udata, Chandrasekhar;
Ganguly, Bishu J.;
Bucktrout, Samantha L.;
Joh, Tenshang;
Shannon, Megan;
Wong, Gilbert Y.;
Levisetti, Matteo;
Garzone, Pamela D.;
Meng, Xu

Publication type:

Article

Correction to: Fit-for-Purpose Quality Control System in Continuous Bioanalysis during Long-Term Pediatric Studies.

Published in:

2020

By:

Ali, Mohsin;
Tins, Jutta;
Burckhardt, Bjoern B.

Publication type:

Correction Notice

Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0414-y

By:

Nøhr-Nielsen, Asbjørn;
Lange, Theis;
Forman, Julie Lyng;
Papathanasiou, Theodoros;
Foster, David J. R.;
Upton, Richard N.;
Bjerrum, Ole Jannik;
Lund, Trine Meldgaard

Publication type:

Article

Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0413-z

By:

Zhong, Zhandong Don;
Jiang, Lynn L.;
Khandelwal, Puneet;
Clarke, Adam W.;
Bakhtiar, Ray;
Zou, Linglong

Publication type:

Article

Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0412-0

By:

Mathews, Joel A.;
Ni, Yan G.;
Wang, Connie;
Peterson, Jon E.;
Ray, Chad;
Zhao, Xuemei;
Duan, Daoyu;
Hamon, Sara;
Allinson, John;
Hokom, Martha;
Wegner, Greta

Publication type:

Article

Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0400-4

By:

Tan, Charles Y.;
Steeno, Gregory S;
You, Zhiping;
Gaitonde, Puneet;
Cai, Chun-Hua;
Kamerud, John;
Gorovits, Boris;
Baltrukonis, Daniel J.

Publication type:

Article

Estimation of the Effect of OAT2-Mediated Active Uptake on Meloxicam Exposure in the Human Liver.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0409-8

By:

Li, Rui;
Mathialagan, Sumathy;
Novak, Jonathan J.;
Eng, Heather;
Riccardi, Keith;
Litchfield, John

Publication type:

Article

Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0408-9

By:

Le Merdy, Maxime;
Tan, Ming-Liang;
Babiskin, Andrew;
Zhao, Liang

Publication type:

Article

Expert Discussion of the Role of Rate Constant Versus Clearance Approaches to Define Drug Pharmacokinetics: Theoretical and Clinical Considerations.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0407-x

By:

Martinez, Marilyn N.;
Jelliffe, Roger W.;
Proost, Johannes H.

Publication type:

Article

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0406-y

By:

Zarmpi, Panagiota;
Flanagan, Talia;
Meehan, Elizabeth;
Mann, James;
Fotaki, Nikoletta

Publication type:

Article

Polymeric Nanocarrier Formulations of Biologics Using Inverse Flash NanoPrecipitation.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0405-z

By:

Markwalter, Chester E.;
Pagels, Robert F.;
Hejazi, Ava N.;
Gordon, Akiva G. R.;
Thompson, Alexandra L.;
Prud'homme, Robert K.

Publication type:

Article

Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0403-1

By:

Gorovits, Boris;
Fiscella, Michele;
Havert, Mike;
Koren, Eugen;
Long, Brian;
Milton, Mark;
Purushothama, Shobha

Publication type:

Article

The Production, Quality Control, and Characterization of ZED8, a CD8-Specific 89Zr-Labeled Immuno-PET Clinical Imaging Agent.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0392-0

By:

Gill, Herman;
Seipert, Richard;
Carroll, Vincent M.;
Gouasmat, Alexandra;
Yin, Jian;
Ogasawara, Annie;
de Jong, Isabella;
Phan, Minh Michael;
Wang, Xiangdan;
Yang, Jihong;
Ilovich, Ohad;
Marik, Jan;
Williams, Simon-Peter

Publication type:

Article

An Agent-Based Systems Pharmacology Model of the Antibody-Drug Conjugate Kadcyla to Predict Efficacy of Different Dosing Regimens.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0391-1

By:

Menezes, Bruna;
Cilliers, Cornelius;
Wessler, Timothy;
Thurber, Greg M.;
Linderman, Jennifer J.

Publication type:

Article

Development of a Population Pharmacokinetics-Based in vitro-in vivo Correlation Model for Drugs with Site-Dependent Absorption: the Acyclovir Case Study.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0382-2

By:

Shin, Soyoung;
Kim, Tae Hwan;
Lee, Da Young;
Chung, Seung Eun;
Lee, Jong Bong;
Kim, Do-Hyung;
Shin, Beom Soo

Publication type:

Article

Antibody Coadministration as a Strategy to Overcome Binding-Site Barrier for ADCs: a Quantitative Investigation.

Published in:

AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-019-0387-x

By:

Singh, Aman P.;
Guo, Leiming;
Verma, Ashwni;
Wong, Gloria Gao-Li;
Thurber, Greg M.;
Shah, Dhaval K.

Publication type:

Article