How has CDER prepared for the nano revolution? A review of risk assessment, regulatory research, and guidance activities

KM Tyner, N Zheng, S Choi, X Xu, P Zou, W Jiang… - The AAPS Journal, 2017 - Springer
Abstract The Nanotechnology Risk Assessment Working Group in the Center for Drug
Evaluation and Research (CDER) within the United States Food and Drug Administration …

Synthesis, characterization and evaluation of a quadripolymer with low molecular weight as a water based drilling fluid viscosity reducer at high temperature (245° C)

W Huang, C Zhao, Z Qiu, YK Leong… - Polymer …, 2015 - Wiley Online Library
To construct an ultra‐high temperature stable drilling mud with a relatively low viscosity, a
new viscosity‐reducing additive was synthesized and evaluated. This additive is a …

Physicochemical and structural characterization of iron–sucrose formulations: a comparative study

BS Barot, PB Parejiya, DM Mehta… - Pharmaceutical …, 2014 - Taylor & Francis
Intravenous polynuclear iron formulations are vital components in the treatment of iron
deficiency anemia associated with chronic kidney disease as well as other diseases …

Development and validation of a high performance chromatographic method for determining sumatriptan in niosomes

MJ Cózar-Bernal, AM Rabasco… - … of pharmaceutical and …, 2013 - Elsevier
In this paper, a novel, precise, specific, accurate and rapid reversed-phase high
performance liquid chromatographic method was developed, optimized and validated for …

Pharmaceutical characterization and thermodynamic stability assessment of a colloidal iron drug product: iron sucrose

RB Shah, Y Yang, MA Khan, A Raw… - International Journal of …, 2014 - Elsevier
The study objective was to evaluate the thermodynamic stability of iron sucrose complexes
as determined by molecular weight (mw) changes. The first part of the study focused on the …

A novel biomarker for retinal degeneration: vitreous body neurofilament proteins

A Petzold, A Junemann, K Rejdak, T Zarnowski… - Journal of neural …, 2009 - Springer
Retinal degeneration leads to release of cell-type specific proteins into the adjacent
compartment. Here we investigated whether the neurofilament heavy chain protein (NfH) …

Concurrent multiresponse multifactorial screening of an electrodialysis process of polluted wastewater using robust non-linear Taguchi profiling

GJ Besseris - Chemometrics and Intelligent Laboratory Systems, 2020 - Elsevier
Electrodialysis is an important chemical process that separates pollutants from wastewater
pools to produce clean water for consumption and irrigation. Initial wastewater concentration …

Pharmaceutical stability of colloidal saccharated iron oxide injection in normal saline

D Hira, A Suzuki, Y Kono, K Shimokawa… - … Health Care and …, 2018 - Springer
Background Colloidal saccharated iron oxide injection is used for the treatment of iron
deficiency anemia in patients with a poor oral intake. Because of the poor stability of the …

Design, development and evaluation of Miconazole Nitrate topical gel for fungal infections.

S Nagalakshmi, RR Radhika Ramaswamy, R Renuga… - 2015 - cabidigitallibrary.org
Abstract In this investigation, Miconazole Nitrate topical gels were designed by employing
various bioadhesive polymers like polyacrylates (carbopol 940), cellulose derivatives …

Optimizing UPLC isocyanate determination through a Taguchi experimental design approach

C André, F Jorge, I Castanheira… - Journal of …, 2013 - Wiley Online Library
The development of a chromatographic procedure for an ultra‐performance liquid
chromatography can be a very time‐consuming task, as the general approach for finding the …