Biomarker or a biological marker is a quantitative substance present in an organism that acts as an indicator of biological conditions like pharmacological (therapeutic), pathogenic (toxic) or any normal biological processes. It helps in the prediction of the diseases and the biochemical reactions that occur inside the organism.
These Biomarkers are introduced into an organism in traces to validate the function of the organs and other health aspects. Biomarkers can be a gene, genetic product, enzyme, hormone or a molecule which have various activities and functions inside the organism.
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There are various types of biomarkers which include fluorescent biomarkers, blood-based biomarkers, pro-inflammatory biomarkers, hematological biomarkers and obesity biomarkers.
These molecular biomarkers involve in the processes of disease diagnosis, disease prognosis, prediction and calculation of the treatment response and the evaluation of the biomarkers. The molecular biomarkers are developed and validated to use it in drug development processes. There are various molecular biomarkers like protein biomarkers, nucleic acid biomarkers, small molecule biomarkers, lipid biomarkers and micro RNA biomarkers.
Nucleic acid based biomarkers
Small molecule biomarkers
Biomarkers have a greater role in the study of cancer, which involves in the risk assessment, screening, diagnosis, prognosis, prediction of the treatment response, and monitoring of the progression of the disease. As the biomarkers play an important role in every condition of the disease, the biomarkers is evaluated accurately, including analytical validation, clinical validation and clinical utility assessment, incorporating into routine clinical care. Cancer Biomarkers are also useful in the process of developing drug targets that makes it easy to deliver the drugs.
Pharmacodynamic cancer biomarkers
Biomarkers in cancer research and medicine
Cancer epidemiology and biomarkers
Immuno oncology biomarkers
Biomarkers for the prognosis of cancer and prediction of treatment
Use of biomarkers for developing drug targets.
Biomarkers for Toxicity Prediction
Biomarkers are used for the prediction of Toxicity because these biomarkers act as an indicator when there is a toxic response that takes place in the system. Many qualified biomarkers are being used to predict and detect the toxic reactions that occur in the body. There are many translational biomarkers used in the study of toxins that plays a crucial role in the toxicity prediction.
Next generation biomarkers for predicting toxicity
Translational Biomarkers in toxicology
Biomarkers as indicator of toxicity in clinical trails
Biomarkers and diseases:
Biomarkers play a vital role in various neurological, cardiovascular and rheumatic diseases which are incurable for a long time are made a possible treatment and diagnosis with the developing advancements in biomarkers through various diagnostics and imaging technologies. These biomarkers have brought a great revolution to the disease prediction, diagnosis and treatment of the diseases that were difficult to handle before.
• Disease-related biomarkers
• Asthma biomarkers
• Biomarkers for Cardiovascular diseases
• Biomarkers for neurological disorders
• Biomarkers for Rheumatic diseases
• Alzheimers biomarker
Biomarkers and Next-Generation Sequencing:
Next generation sequencing or high-throughput sequencing involves in DNA sequencing and RNA sequencing which is quick and cheap than the previously used method called Sanger sequencing and also there is a revolution in the study of genomics and molecular biology due to the Next-generation Sequencing.
Thus genome sequencing using next generation sequencing helps in the discovery of biomarkers.
• Next generation sequencing for the discovery of Biomarkers
• Genome sequencing for the discovery of Biomarkers
• MicroRNA sequencing for the prediction of diseases
• Using SNP as biomarkers
• Genome biomarkers
• Cell proliferation markers
• Cytogenetic biomarkers
• Oxidative stress biomarkers
Transcriptional profiling is a technique used to identify the differences in the gene expression between the diseased tissues and the healthy tissues. DNA sequencing, mRNA profiling, Proteomics, and Systems Biology help in the analysis of the transcriptional profiling. Expressed sequence tags and DNA microarrays are the techniques that are used in transcriptional profiling.
Biomarkers and Radiology:
Biomarkers are detectable parameters which can be biochemical, genetic, histologic, anatomic, physical, functional, or metabolic.
It promotes research and also leverage advances in bioinformatics.
• Imaging biomarkers
• Quantitative imaging biomarkers
Biomarkers and Nanotechnology:
Nanoparticles and nano devices are developed for the detection of biomarkers solving nanotoxicology issues and other challenges.
• Nanotechnology based biomarker detection
• Interaction of biomarkers with nanoparticles
• Mining for biomarkers with nanotechnology
• Early detection of cancer using nanotechnology
• Applications of nanotechnology in Biomarkers
Current Researches in Biomarkers:
Current research on Biomarkers includes new therapeutic strategies to solve the issues taking place inside the body. Biomarker research is done in neurology, oncology, glucose disorders and several critical diseases. There are discoveries like biomarkers of exposure for dietary, environmental and metabolic cancer risk factors.
• Biomarkers and new therapeutic strategies
• Biomarker research in Neurology
• Discovery of novel biomarkers of exposure for dietary, environmental, and metabolic cancer risk factors
• Challenges in Biomarkers research
• Biomarkers of Environmental Pollutants.
Clinical Applications of Biomarkers:
There are various clinical applications of Biomarkers in the treatment of cardiovascular diseases, acute kidney injuries, and cancer treatments. The Biomarkers are used in the development of vaccines and drug which is a major application in the field of drug discovery and development.
• Clinical Applications in Cardiovascular diseases
• Application of Biomarkers in the development of drugs
• Vaccine and drug development
Drug discovery is the process through which potential new medicines are identified. It involves a wide range of scientific disciplines, including biology, chemistry and pharmacology.
It is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery.
Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology.
The idea that the effect of a drug in the human body is mediated by specific interactions of the drug molecule with biological macromolecules, (proteins or nucleic acids in most cases) led scientists to the conclusion that individual chemicals are required for the biological activity of the drug. This made for the beginning of the modern era in pharmacology, as pure chemicals, instead of crude extracts of medicinal plants, became the standard drugs.
Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication.
Drug Development Process
The drug development process involves 9 steps:
Drug discovery and target validation
This is where drug development companies choose a molecule, such as a gene or protein, to target with a drug.
Step 2: Preclinical testing
The next step in the drug development process is preclinical testing, which in itself is divided into two subcomponents: in vitro and in vivo testing.
Step 3: Investigational New Drug application filing
The third step involves submitting an Investigational New Drug application to the FDA prior to beginning human clinical trials.
Step 4: Phase 1 clinical studies
The first phase of human clinical testing involves a relatively small group of healthy people, usually a dozen to a few dozen, and it'll focus entirely on safety. This stage of study involves looking at how a drug is absorbed and eliminated from the body, as well as what side effects it may cause and whether or not it's producing the desired effect.
Step 5: Phase 2 clinical studies
The two big changes between early stage and mid-stage trials are that the patient pool widens from a few dozen to perhaps 100 or more patients, and the patients being treated are no longer healthy volunteers but people being afflicted by the disease in question.
Step 6: Phase 3 clinical studies
In phase 3 studies, safety remains a priority, but this is where efficacy also plays a big role. Phase 3 studies are designed by drug developers but approved by the FDA with guidelines for a clearly defined primary endpoint to determine the success or failure of a tested drug. Phase 3 trials involve even more patients, perhaps a few hundred to maybe thousands, and they are by far the longest and costliest of all components of the drug development process.
Step 7: New Drug Application filing
The seventh step in the drug development process is simple: filing a New Drug Application with the FDA.
Step 8: PDUFA date and decision
More often than not, the FDA will wait until the PDUFA date to release its decision. Essentially the FDA has three choices: it can approve a drug; it can outright deny a drug.
Step 9: Phase 4 clinical studies
Even after approval, it's not uncommon for the FDA to request long-term safety studies be undertaken whereby drug developers are required to submit regular reports detailing any adverse events with the drug to the FDA.
safety biomarkerCancer Biomarkers?
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Oxidative Stress Biomarkers