Results 131 to 140 of about 953,056 (326)

Process development for production of non-originator NISTmAb from CHO and NS0 cell lines

mAbs
Cell lines that produce non-originator versions of the National Institute of Standards and Technology (NIST) monoclonal antibody reference material 8671 (NISTmAb) are invaluable to the biopharmaceutical industry because, unlike typical commercial cell ...
Erica J. Fratz-Berilla, Nicole Azer, Xin Bush, JungHyun Kim, Casey Kohnhorst   +4 more
doaj   +1 more source

Was It Something I Ate? Implementation of the FDA Seafood HACCP Program [PDF]

We use FDA’s seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between ...
Anna Alberini, Dominic Mancini, Erik Lichtenberg, Gregmar I. Galinato   +3 more
core  

FDA begins active monitoring of drug safety

, 2008
B. Roehr
openalex   +2 more sources

Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices? [PDF]

, 2021
Charles E. Binkley, Michael S Politz, Brian P. Green   +2 more
openalex   +1 more source

Engineering a Sonotherapeutic RBC Membrane‐Derived Nanoparticle Platform for the Treatment of Liver Cancer

Advanced Functional Materials, EarlyView.
Herein, an RBC membrane‐derived nanoparticle (CMN‐ICG) is engineered to efficiently deliver a sonosensitizing agent, indocyanine green (ICG), for sonotherapy of hepatocellular carcinoma (HCC). CMN‐ICG exhibits excellent cytocompatibility, significantly enhances hepatocyte uptake, and produces excessive reactive oxygen species (ROS) upon ultrasound ...
Alap Ali Zahid, Aishik Chakraborty, Wei Luo, Juhi Bora, John Joseph Kelly, John Andrew Ronald, Arghya Paul   +6 more
wiley   +1 more source

PRELIVE: A Framework for Predicting Lipid Nanoparticles In Vivo Efficacy and Reducing Reliance on Animal Testing

Advanced Functional Materials, EarlyView.
PREdicting LNP In Vivo Efficacy (PRELIVE) framework enables the prediction of lipid nanoparticle (LNPs) organ‐specific delivery through dual modeling approaches. Composition‐based models using formulation parameters and protein corona‐based models using biological fingerprints both achieve high predictive accuracy across multiple organs.
Belal I. Hanafy, Chuan‐En Lu, Kai Liu, Audrey Gallud   +3 more
wiley   +1 more source

Regulatory Science Needs for Neonates: A Call for Neonatal Community Collaboration and Innovation

Frontiers in Pediatrics, 2014
Susan K McCune, Yeruk Ager Mulugeta
doaj   +1 more source

IMPACT OF THE 2002 BIOTERRORISM ACT ON THE NEW JERSEY FOOD INDUSTRY [PDF]

This paper provides an overview of the four key sections of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, with regard to Administrative Detention (Section 303), Facilities Registration (Section 305), Records and ...
Onyango, Benjamin M., Schilling, Brian J., Turvey, Calum G.   +2 more
core   +1 more source

Istradefylline Safety Profiles: Examination of Individual Case Safety Reports in the FDA Adverse Event Reporting System (FAERS) Database [PDF]

WU Wen-hua, Haoxin Liang, Zhengrui Chen, Shuzhen Zhu   +3 more
openalex   +1 more source

VIVID: A qPCR‐Based Platform for Sensitive and Quantitative In Vivo Tracking of Extracellular Vesicles

Advanced Functional Materials, EarlyView.
This study introduces VIVID (Vesicle In Vivo Identification using DNA), a qPCR‐based platform that tracks PCR‐amplifiable DNA tags loaded in the EVs for accurate and quantifiable EV biodistribution in vivo. ABSTRACT Extracellular vesicles (EVs) represent promising carriers for nucleic acid therapeutics, offering advantages over synthetic nanoparticles ...
Oscar Boyadjian, Talin Ebrahimian, Jonathan Miranda O'Connor, Janusz Rak, Stephanie Lehoux, Maryam Tabrizian   +5 more
wiley   +1 more source