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Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing
Springer Science and Business Media LLC - - 2024
Selina Wilson, Julianne Farabaugh, Yemin Liu, Zhao Liu, Rachel Meyers, Matthew Santangelo, Karen Thompson
Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosage forms due to a medical condition or treatment that affects the ability to swallow or the function of the gastrointestinal tract. Off-label administration of oral drug products via EFT raises concerns for pharmaceutical sponsors, regulators, and healthcare practitioners (HCPs...... hiện toàn bộ
A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics
Springer Science and Business Media LLC - Tập 15 - Trang 1141-1154 - 2013
Xiaoying Chen, Timothy Hickling, Eugenia Kraynov, Bing Kuang, Chuenlei Parng, Paolo Vicini
A mathematical pharmacokinetic/anti-drug-antibody (PK/ADA) model was constructed for quantitatively assessing immunogenicity for therapeutic proteins. The model is inspired by traditional pharmacokinetic/pharmacodynamic (PK/PD) models, and is based on the observed impact of ADA on protein drug clearance. The hypothesis for this work is that altered drug PK contains information about the extent and...... hiện toàn bộ
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products
Springer Science and Business Media LLC - Tập 22 Số 5 - 2020
Arzu Selen, Anette Müllertz, Filippos Kesisoglou, Rodney J. Y. Ho, Jack Cook, Paul Dickinson, Talia Flanagan
Are Physiologically Based Pharmacokinetic Models Reporting the Right Cmax? Central Venous Versus Peripheral Sampling Site
Springer Science and Business Media LLC - Tập 17 - Trang 1268-1279 - 2015
Helen Musther, Katherine L. Gill, Manoranjenni Chetty, Amin Rostami-Hodjegan, Malcolm Rowland, Masoud Jamei
Physiologically based pharmacokinetic (PBPK) models can over-predict maximum plasma concentrations (Cmax) following intravenous administration. A proposed explanation is that invariably PBPK models report the concentration in the central venous compartment, rather than the site where the samples are drawn. The purpose of this study was to identify and validate potential corrective models based on ...... hiện toàn bộ
Pharmacokinetic and Pharmacodynamic Analysis of Hyperthermic Intraperitoneal Oxaliplatin-Induced Neutropenia in Subjects with Peritoneal Carcinomatosis
Springer Science and Business Media LLC - Tập 13 Số 1 - Trang 72-82 - 2011
Belén Valenzuela, Ricardo Nalda‐Molina, Pedro Bretcha-Boix, Vanesa Escudero-Ortíz, María J. Duart, Vicente Carbonell, Manuel Sureda, Joseba Rebollo, J. Farré, Antonio Brugarolas, Juan José Pérez-Ruixo
Clarithromycin, Midazolam, and Digoxin: Application of PBPK Modeling to Gain New Insights into Drug–Drug Interactions and Co-medication Regimens
Springer Science and Business Media LLC - Tập 19 - Trang 298-312 - 2016
Daniel Moj, Nina Hanke, Hannah Britz, Sebastian Frechen, Tobias Kanacher, Thomas Wendl, Walter Emil Haefeli, Thorsten Lehr
Clarithromycin is a substrate and mechanism-based inhibitor of cytochrome P450 (CYP) 3A4 as well as a substrate and competitive inhibitor of P-glycoprotein (P-gp) and organic anion-transporting polypeptides (OATP) 1B1 and 1B3. Administered concomitantly, clarithromycin causes drug–drug interactions (DDI) with the victim drugs midazolam (CYP3A4 substrate) and digoxin (P-gp substrate). The objective...... hiện toàn bộ
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium
Springer Science and Business Media LLC - Tập 24 - Trang 1-13 - 2022
Marta Starcevic Manning, Mohamed Hassanein, Michael A. Partridge, Vibha Jawa, Johanna Mora, Josiah Ryman, Breann Barker, Christian Braithwaite, Kevin Carleton, Laura Hay, Charles Hottenstein, Robert J. Kubiak, Viswanath Devanarayan
During biotherapeutic drug development, immunogenicity is evaluated by measuring anti-drug antibodies (ADAs). The presence and magnitude of ADA responses is assessed using a multi-tier workflow where samples are screened, confirmed, and titered. Recent reports suggest that the assay signal to noise ratio (S/N) obtained during the screening tier correlates well with titer. To determine whether S/N ...... hiện toàn bộ
Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development
Springer Science and Business Media LLC - - 2011
Xinyuan Zhang, Robert Lionberger, Barbara M. Davit, Lawrence X. Yu
Regional permeability of salmon calcitonin in isolated rat gastrointestinal tracts: Transport mechanism using Caco-2 cell monolayer
Springer Science and Business Media LLC - - 2004
Rakhi B. Shah, Mansoor A. Khan
The objective of the study was to determine the region of maximum permeation of salmon calcitonin (sCT) through the gastrointestinal tract and to investigate the mechanism of permeation. For regional permeability determination, male Sprague-Dawley rats (250–300 g) were anesthetized and the gastrointestinal tissues were isolated. Stomach, duodenum, jejunum, ileum, or colon tissues were mounted on N...... hiện toàn bộ
The Coulter Principle for Analysis of Subvisible Particles in Protein Formulations
Springer Science and Business Media LLC - - 2011
Matthew N. Rhyner
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