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The progression of chemically modified mRNA therapeutics through development pipelines is accelerating for many disease indications and the need to assess these analytes is becoming more routine for the pharmaceutical industry and contract research organizations. This article describes some of the challenges and strategies for performing regulated bioanalysis of modified mRNA therapeutics by comparing the two main analytical approaches - quantitative reverse transcription PCR and branched DNA.
This article was published in the following journal.
The nature of a construct's measurement model, most decisively being predominantly reflective or formative, is essential for its development, validation and use. Differentiating between these types of...
Measurement of modified biologic including coagulation factors with extended half-life obtained for example by polysialylation pose an analytical challenge especially if both biological activity and p...
Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation...
Careful consideration of the validity and reliability of methods intended to assess dietary intake is central to the robustness of nutrition research. A dietary assessment method with high validity is...
Alzheimer disease (AD) is the leading cause of dementia worldwide. With 35 million people over 60 years of age with dementia, there is an urgent need to develop new treatments for AD. To streamline th...
iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers ...
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based method will be compared to those obtained by spirometry using a flow based pneumotachograph method....
Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with...
The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC ...
An azo dye used in blood volume and cardiac output measurement by the dye dilution method. It is very soluble, strongly bound to plasma albumin, and disappears very slowly.
The non-genetic biological changes of an organism in response to challenges in its ENVIRONMENT.
A unit of the National Institutes of Health that seeks to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Center was established in 2011.
A method of non-invasive, continuous measurement of MICROCIRCULATION. The technique is based on the values of the DOPPLER EFFECT of low-power laser light scattered randomly by static structures and moving tissue particulates.
The measurement around the body at the level of the ABDOMEN and just above the hip bone. The measurement is usually taken immediately after exhalation.
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...
Polymerase Chain Reaction (PCR)
PCR (Polymerase Chain Reaction) uses the ability of DNA polymerase (enzymes that create DNA molecules by assembling nucleotides, the building blocks of DNA. These enzymes are essential to DNA replication and usually work in pairs to create two ident...
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...