Works matching IS 15507416 AND DT 2018 AND VI 20 AND IP 5

Results: 13

Reflections on FDA Draft Guidance for Products Containing Nanomaterials: Is the Abbreviated New Drug Application (ANDA) a Suitable Pathway for Nanomedicines?

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0255-0

By:

Emily, Marden;
Ioanna, Ntai;
Scott, Bass;
Beat, Flühmann

Publication type:

Article

A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0249-y

By:

Brekkan, Ari;
Lopez-Lazaro, Luis;
Yngman, Gunnar;
Plan, Elodie L.;
Acharya, Chayan;
Hooker, Andrew C.;
Kankanwadi, Suresh;
Karlsson, Mats O.

Publication type:

Article

Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0242-5

By:

Ryeznik, Yevgen;
Sverdlov, Oleksandr;
Hooker, Andrew C.

Publication type:

Article

Screening of Drug-Transporter Interactions in a 3D Microfluidic Renal Proximal Tubule on a Chip.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0247-0

By:

Vriend, Jelle;
Nieskens, Tom T. G.;
Vormann, Marianne K.;
van den Berge, Bartholomeus T.;
van den Heuvel, Angelique;
Russel, Frans G. M.;
Suter-Dick, Laura;
Lanz, Henriëtte L.;
Vulto, Paul;
Masereeuw, Rosalinde;
Wilmer, Martijn J.

Publication type:

Article

Using Clinical PK/PD Studies to Support No Clinically Meaningful Differences Between a Proposed Biosimilar and the Reference Product.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0246-1

By:

Zhu, Peijuan;
Ji, Ping;
Wang, Yaning

Publication type:

Article

Combining Extracellular miRNA Determination with Microfluidic 3D Cell Cultures for the Assessment of Nephrotoxicity: a Proof of Concept Study.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0245-2

By:

Suter-Dick, Laura;
Mauch, L.;
Ramp, D.;
Caj, M.;
Vormann, M. K.;
Hutter, S.;
Lanz, H. L.;
Vriend, J.;
Masereeuw, R.;
Wilmer, M. J.

Publication type:

Article

Virtual Thorough QT (TQT) Trial—Extrapolation of In Vitro Cardiac Safety Data to In Vivo Situation Using Multi-Scale Physiologically Based Ventricular Cell-wall Model Exemplified with Tolterodine and Fesoterodine.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0244-3

By:

Patel, Nikunjkumar;
Wisniowska, Barbara;
Polak, Sebastian

Publication type:

Article

Nephrotoxicity and Kidney Transport Assessment on 3D Perfused Proximal Tubules.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0248-z

By:

Vormann, Marianne K.;
Gijzen, Linda;
Hutter, Simon;
Boot, Lisette;
Nicolas, Arnaud;
van den Heuvel, Angelique;
Vriend, Jelle;
Chee Ping Ng;
Nieskens, Tom T. G.;
van Duinen, Vincent;
de Wagenaar, Bjorn;
Masereeuw, Rosalinde;
Suter-Dick, Laura;
Trietsch, Sebastiaan J.;
Wilmer, Martijn;
Joore, Jos;
Vulto, Paul;
Lanz, Henriette L.

Publication type:

Article

Effect of Inhalation Flow Rate on Mass-Based Plume Geometry of Commercially Available Suspension pMDIs.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0241-6

By:

Moraga-Espinoza, Daniel F.;
Eshaghian, Eli;
Shaver, Albert;
Smyth, Hugh D. C.

Publication type:

Article

Model-Based Residual Post-Processing for Residual Model Identification.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0240-7

By:

Ibrahim, Moustafa M. A.;
Nordgren, Rikard;
Kjellsson, Maria C.;
Karlsson, Mats O.

Publication type:

Article

Assessment of Three-Drug Combination Pharmacodynamic Interactions in Pancreatic Cancer Cells.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0235-4

By:

Molins, Emilie A. G.;
Jusko, William J.

Publication type:

Article

Exact Gradients Improve Parameter Estimation in Nonlinear Mixed Effects Models with Stochastic Dynamics.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0232-7

By:

Olafsdottir, Helga Kristin;
Leander, Jacob;
Almquist, Joachim;
Jirstrand, Mats

Publication type:

Article

A Non-invasive Liquid Biopsy Screening of Urine-Derived Exosomes for miRNAs as Biomarkers in Endometrial Cancer Patients.

Published in:

AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0220-y

By:

Srivastava, Akhil;
Moxley, Katherine;
Ruskin, Rachel;
Dhanasekaran, Danny Natarajan;
Zhao, Yan Daniel;
Ramesh, Rajagopal

Publication type:

Article