Works matching IS 15507416 AND DT 2015 AND VI 17 AND IP 4

Results: 25

Applying Biopharmaceutical Classification System (BCS) Criteria to Predict Oral Absorption of Drugs in Dogs: Challenges and Pitfalls.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 948, doi. 10.1208/s12248-015-9743-7

By:

Papich, Mark;
Martinez, Marilyn

Publication type:

Article

Intranasal Delivery of Proteins and Peptides in the Treatment of Neurodegenerative Diseases.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 780, doi. 10.1208/s12248-015-9719-7

By:

Meredith, M.;
Salameh, Therese;
Banks, William

Publication type:

Article

On the Incorrect Statistical Calculations of the Kinetica Software Package in Imbalanced Designs.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 1033, doi. 10.1208/s12248-015-9749-1

By:

Morales-Alcelay, S.;
Torre de Alvarado, J.;
García-Arieta, A.

Publication type:

Article

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 881, doi. 10.1208/s12248-015-9750-8

By:

Budha, Nageshwar;
Leabman, Maya;
Jin, Jin;
Wada, D.;
Baruch, Amos;
Peng, Kun;
Tingley, Whittemore;
Davis, John

Publication type:

Article

In Vitro, Pharmacokinetic, Pharmacodynamic, and Safety Comparisons of Single and Combined Administration of Tiotropium and Salmeterol in COPD Patients Using Different Dry Powder Inhalers.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 871, doi. 10.1208/s12248-015-9751-7

By:

Horhota, Stephen;
Noord, Jan;
Verkleij, Cynthia;
Bour, Loek;
Sharma, Ashish;
Trunk, Michael;
Cornelissen, Piet

Publication type:

Article

Molecular Imaging of Membrane Transporters' Activity in Cancer: a Picture is Worth a Thousand Tubes.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 788, doi. 10.1208/s12248-015-9752-6

By:

Mann, Aniv;
Semenenko, Inessa;
Meir, Michal;
Eyal, Sara

Publication type:

Article

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 891, doi. 10.1208/s12248-015-9753-5

By:

Jiang, Wenlei;
Makhlouf, Fairouz;
Schuirmann, Donald;
Zhang, Xinyuan;
Zheng, Nan;
Conner, Dale;
Yu, Lawrence;
Lionberger, Robert

Publication type:

Article

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

Published in:

2015

By:

Yu, Lawrence;
Baker, Jeffrey;
Berlam, Susan;
Boam, Ashley;
Brandreth, E.;
Buhse, Lucinda;
Cosgrove, Thomas;
Doleski, David;
Ensor, Lynne;
Famulare, Joseph;
Ganapathy, Mohan;
Grampp, Gustavo;
Hussong, David;
Iser, Robert;
Johnston, Gordon;
Kesisoglou, Filippos;
Khan, Mansoor;
Kozlowski, Steven;
Lacana, Emanuela;
Lee, Sau

Publication type:

Report

Peptide Developability at the Discovery-to-Development Interface-Current State and Future Opportunities.

Published in:

2015

By:

Bak, Annette;
Dai, Weiguo

Publication type:

Editorial

Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 939, doi. 10.1208/s12248-015-9756-2

By:

Marcelletti, John;
Evans, Cindy;
Saxena, Manju;
Lopez, Adriana

Publication type:

Article

Multidrug Resistance Proteins (MRPs) and Cancer Therapy.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 802, doi. 10.1208/s12248-015-9757-1

By:

Zhang, Yun-Kai;
Wang, Yi-Jun;
Gupta, Pranav;
Chen, Zhe-Sheng

Publication type:

Article

Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 988, doi. 10.1208/s12248-015-9759-z

By:

Mathias, Neil;
Xu, Yan;
Vig, Balvinder;
Kestur, Umesh;
Saari, Amy;
Crison, John;
Desai, Divyakant;
Vanarase, Aditya;
Hussain, Munir

Publication type:

Article

Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 853, doi. 10.1208/s12248-015-9760-6

By:

Borghardt, Jens;
Weber, Benjamin;
Staab, Alexander;
Kloft, Charlotte

Publication type:

Article

Poly(butylcyanoacrylate) and Poly(ε-caprolactone) Nanoparticles Loaded with 5-Fluorouracil Increase the Cytotoxic Effect of the Drug in Experimental Colon Cancer.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 918, doi. 10.1208/s12248-015-9761-5

By:

Ortiz, Raúl;
Cabeza, Laura;
Arias, José;
Melguizo, Consolación;
Álvarez, Pablo;
Vélez, Celia;
Clares, Beatriz;
Áranega, Antonia;
Prados, Jose

Publication type:

Article

Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 976, doi. 10.1208/s12248-015-9762-4

By:

Ni, Yan;
Yuan, Xiling;
Newitt, John;
Peterson, Jon;
Gleason, Carol;
Haulenbeek, Jonathan;
Santockyte, Rasa;
Lafont, Virginie;
Marsilio, Frank;
Neely, Robert;
DeSilva, Binodh;
Piccoli, Steven

Publication type:

Article

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 837, doi. 10.1208/s12248-015-9763-3

By:

Forbes, Ben;
Bäckman, Per;
Christopher, David;
Dolovich, Myrna;
Li, Bing;
Morgan, Beth

Publication type:

Article

Applications of In Vitro- In Vivo Correlations in Generic Drug Development: Case Studies.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 1035, doi. 10.1208/s12248-015-9765-1

By:

Kaur, Paramjeet;
Jiang, Xiaojian;
Duan, John;
Stier, Ethan

Publication type:

Article

Antibody Drug Conjugates: Application of Quantitative Pharmacology in Modality Design and Target Selection.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 828, doi. 10.1208/s12248-015-9766-0

By:

Sadekar, S.;
Figueroa, I.;
Tabrizi, M.

Publication type:

Article

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.

Published in:

2015

By:

Kelley, Marian;
Stevenson, Lauren;
Golob, Michaela;
Devanarayan, Viswanath;
Pedras-Vasconcelos, Joao;
Staack, Roland;
Jenkins, Rand;
Booth, Brian;
Wakshull, Eric;
Bowsher, Ronald;
Rock, Marie;
Dudal, Sherri;
DeSilva, Binodh

Publication type:

Report

A Systematic Analysis of the Sensitivity of Plasma Pharmacokinetics to Detect Differences in the Pulmonary Performance of Inhaled Fluticasone Propionate Products Using a Model-Based Simulation Approach.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 999, doi. 10.1208/s12248-015-9768-y

By:

Weber, Benjamin;
Hochhaus, Guenther

Publication type:

Article

Anti-repulsive Guidance Molecule C (RGMc) Antibodies Increases Serum Iron in Rats and Cynomolgus Monkeys by Hepcidin Downregulation.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 930, doi. 10.1208/s12248-015-9770-4

By:

Böser, Preethne;
Seemann, Dietmar;
Liguori, Michael;
Fan, Leimin;
Huang, Lili;
Hafner, Mathias;
Popp, Andreas;
Mueller, Bernhard

Publication type:

Article

Effect of Type 2 Diabetes Mellitus and Diabetic Nephropathy on IgG Pharmacokinetics and Subcutaneous Bioavailability in the Rat.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 965, doi. 10.1208/s12248-015-9771-3

By:

Chadha, Gurkishan;
Morris, Marilyn

Publication type:

Article

Translational Nano-Medicines: Targeted Therapeutic Delivery for Cancer and Inflammatory Diseases.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 813, doi. 10.1208/s12248-015-9772-2

By:

Talekar, Meghna;
Tran, Thanh-Huyen;
Amiji, Mansoor

Publication type:

Article

Early Drug Discovery Prediction of Proarrhythmia Potential and Its Covariates.

Published in:

2015

By:

Polak, Sebastian;
Pugsley, Michael;
Stockbridge, Norman;
Garnett, Christine;
Wiśniowska, Barbara

Publication type:

Report

Mathematical Models to Explore Potential Effects of Supersaturation and Precipitation on Oral Bioavailability of Poorly Soluble Drugs.

Published in:

AAPS Journal, 2015, v. 17, n. 4, p. 902, doi. 10.1208/s12248-015-9748-2

By:

Kleppe, Mary;
Forney-Stevens, Kelly;
Haskell, Roy;
Bogner, Robin

Publication type:

Article