Biomarker testing services
are efficient enough to aid the industry and the researchers with their work in
measuring different pathogenic, physiological, and therapy induced
characteristics within the biological system. Thus, robust biomarker assays
have become the necessity for transitioning the drug or the diagnostic device
from its bench to its bedside.
These are considered as
powerful approaches for eliciting the measurements of the indicators of the
biological processes in both normal as well pathological conditions. Such
biomarker services also contribute a lot to the response of pharmacological
interventions. The analysis of these biomarkers in blood or other related body
fluids either at the protein or DNA levels have been relied by medical practitioners
for studying the progress of human diseases.
The biomarker services
provided by several different biomarker assay testing labs for diagnosing and
managing the clinical conditions in case of cancers, cardiovascular disorders,
genetic disorders, immune responses, etc. Nevertheless, the biomarker assay development and validationapplication in research field has exploded out to burst crucial information
pertaining to the biological reactions with its exposure to the novel
therapeutic drug compounds.
The clinical biomarkers on
the other hand, plays a key role in all the stages of the drug discovery and
development. The biomarker assay services are widely employed for the early
stages of the new chemical entity discovery for determining both the
mechanistic as well as pharmacodynamic responses thereby guiding compound
selection. Thus, such bioanalysis of the biomarkers helps in establishing the
measurements of biological responses and deciding whether the potential
therapeutic drug candidates can be further continued or stopped.
The basic focus of the
biomarker assay development is constructing an assay that suffices the drug
investigational goals. In short, the βfit-for-purposeβ is more widely applied.
This is a level of validation in association with the medical product development
tool. Methods for the biomarkers are labelled to be validated if and only if
those set specific acceptance criteria for both accuracy as well as precision
during the quality control testing over the wider range of the standard curve
throughout the validation study. However, well in advance of validation, it
becomes detrimental for the research to put many labs to work for performing a
limited experiment sets without demonstrating the pre-set acceptance criteria.
This assures that the established testing protocol is robust and will perform
the same throughout the validation.
In case of early drug
discovery and development, establishing compound selection or proof of concept,
the sponsor preference determines the extent of the biomarker validation. Usually
for US market, the FDA demands for full biomarker assay validation in those
scenarios where the study highlights regulatory decision-making, or product
labelling or ascertaining drug safety. In line with these biomarker assay validation guidance, evaluation of all relevant critical bioassay parameters
should lie within the approved acceptance criteria for all determinants such as
sensitivity, precision, accuracy, selectivity, dynamic range, etc. Furthermore,
the biomarker validation shall also cover the parallelism, dilution effects,
cover stability, prozone effect, etc.
This is a consumer-friendly course for the elderly and those who care for them. Its purpose is to make raise awareness of the issues surrounding medication safety, especially for older persons.