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Method Validation Articles & Analysis
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The Food and Drug Administration’s (FDA) recent Roadmap to Reducing Animal Testing in Preclinical Safety Studies marks a pivotal shift toward the adoption of innovative, human-relevant methodologies commonly known as New Approach Methodologies (NAMs). As leaders in preclinical research tools, we welcome this movement towards advanced and validated NAMs solutions already in place. emka ...
Introduction We recently sat down with one of our valued customers, Dr Alexis Rossignol (Clean Cells), to discuss his experience with VIPS PRO, our cutting-edge technology designed to streamline and enhance the early stages of cell line development. This interview provides insight into Clean Cells’ quest to automate and increase single-cell seeding while having undisputable proof ...
Our analytical chemistry services include structure elucidation, impurity profiling, stability testing, and method development/validation, ensuring the quality and integrity of your small molecule candidates. ...
The company specializes in bioanalysis, providing analytical method development and validation, a one-stop solution for health care products, as well as comprehensive characterization of biopharmaceuticals. ...
Throughout this process, qualitative analysis and quantitative analysis are the two most frequently used analytical methods. “In the beginning, people may view pharmaceutical analysis as analytical chemistry dealing with drug substances and pharmaceutical products, but in fact, analytical chemists are involved in many more studies, including the analysis of the chiral ...
Natural Product Identification and Analysis Creative Biostructure provides powerful technologies for the identification and quantification of various components in natural products, such as LC/MS, HPLC, GCMS, SFC, NMR, and provides rapid and highly reproducible validation methods for type, purity, intensity, and composition, thereby providing natural product ...
The complexity of RMID spans the spectrum from analytical techniques/instruments to the testing process to the governmental norms and standards that regulate all aspects of RMID including system suitability, extent of sampling, method validation, electronic records, and many others. ...
Instead, we have to figure out ways to validate our methods using proxies that hopefully reflect the actual results of experiments. ...
One his many areas of expertise is the planning and evaluation of experiments for method validation and he has been involved in international working groups (IFCC, CLSI) in the fields of clinical chemistry and laboratory medicine. ...
This article addresses the method development and verification necessary to use a variable natural material as a key component in a consistent medical device. ...
RESMON PRO FULL is the ONLY diagnostic device that allows the detection of EFL by FOT using the method patented and validated by the Bioengineering department of the Politecnico di Milano University. ...
Comet Assay IV from Perceptive Instruments has a unique scoring method that has been validated both in-house and by many of the world’s leading pharmaceutical organisations and CROs. As part of the JaCVAM initiative to validate the in vivo and in vitro comet assays, Comet Assay IV is currently used by laboratories in Japan, Europe and the ...