In vitro in vivo drug metabolism describes two separate types of test. Here ‘in vitro’ means literally ‘in glass’ or ‘in the test tube’. In other words here then the drug metabolism is tested in some form of test tube. On the other hand the ‘in vivo’ aspect of the in vitro in vivo drug metabolism means ‘in the organism’ which means it is tested inside a subject. The primary site of drug metabolism is the liver.
Meanwhile pharmacokinetics is something slightly different but very related. This is the study of how the body treats the drug in its various forms and its stages as it travels throughout the body. This then involves bioanalysis in order to establish how long it takes for the medication to be broken down, distributed throughout the body, and eventually excreted. Altering the makeup of the medication can then alter how long it takes to be broken down, how it is used in the body and how it is excreted. This might also lead to changes in the delivery system. Pharmacokinetics is distinct from in vitro in vivo drug metabolism as it not only measures how the body uses the active agent, but the journey of the medication from its ingestion to its end.
Meanwhile if you have a slow metabolism, then this will mean that you very slowly break down and use those materials. The metabolism has two types of process – ‘catabolic’ and ‘anabolic’ processes. In catabolic processes the body is breaking down food and stored mass and nutrients in order to fuel the body. Catabolism them is what leads to the burning of fat and the break down of foods and nutrients. On the other hand anabolism is a term that describes the use of these nutrients and chemicals around the body. This then is how the body builds muscle out of protein. Meanwhile this is also how the body will utilize a supplement or medication created by a pharmaceutical company with the intention of aiding the building of tissue etc.
Drug metaboilsm needs to be understood by the pharmaceutical companies so that they know precisely how long it takes for the drug to be broken down and how it will be used by the body. This can be tested using in vitro in vivo drug metabolism.
However DM/PK (note the slash) is the term you are more likely to be hearing, and this refers to ‘Drug Metabolism and Pharmacokinetics’. These are two related terms in biochemistry and pharmaceuticals that allow for the test of pharmaceutical drugs and other agents.
Starting with drug metabolism, this is the process by which the body will break down and then convert active chemical substances (it is actually a stage of pharmacokinetics as we will address later). Essentially then this is what happens to the active ingredients in the medicine once they are inside the body.
This is related to our metabolism which is a term that describes the body’s ability to break down and use any substances. If you describe yourself as having a fast metabolism then this will mean that your body very quickly breaks down and utilizes the nutrients in foods.
When you are in the world of bioanalysis, or if you are just interested in chemistry and pharmaceuticals, you can end up hearing a lot of different acronyms and terms and it is certainly a field that can be a little impenetrable and jargon-filled to begin with. Understanding these terms however – such as in vitro in vivo drug metabolism and pharmcokinetics is crucial both for those working in the field and testing and developing new drugs, as well as for those using them – for whom a better understanding of the biochemistry of the body can help to aid them in using the medication correctly. One of these acronyms is ‘DM/PK’ and this is something you are likely to hear a lot.
There are actually two definitions of DMPK and these are both related to biochemistry. One definition is Dytrophia Myotonica Protein Kinase. This is actually a specific gene in the human body that is tasked with creating the protein of the same name. This is a protein that is involved in the communication between cells, with the regulation and creation of various important structures inside the muscle cells, and for various interactions with other proteins.
In clinical trials then the custom gene synthesis will be used in order to create the immunization. This will then be given to a test subject (often rats). From here a dose solution dried-blood spot assay can be performed on the subjects blood. Dose solution dried-blood spot assay can allow for the sample to be sent away. From here the ELISA biomarkers can be used in order to test for the presence of the created antigen, as well as the antibodies in order to test the effectiveness of the immunization and to therefore allow for changes to be made where necessary.
This then allows for the creation of immunizations that can help to protect us against a vast range of illnesses. While the same ELISA biomarkers can also be used in a range of other industries. This is just one form of bioanalysis – the process of testing for the amount of a substance in a sample – and there are many other tests that can be carried out to establish the presence and quantities of various other substances after clinical sample collection.
In clinical trials then the custom gene synthesis will be used in order to create the immunization. This will then be given to a test subject (often rats). From here a dose solution dried-blood spot assay can be performed on the subjects blood. Dose solution dried-blood spot assay can allow for the sample to be sent away. From here the ELISA biomarkers can be used in order to test for the presence of the created antigen, as well as the antibodies in order to test the effectiveness of the immunization and to therefore allow for changes to be made where necessary.
This then allows for the creation of immunizations that can help to protect us against a vast range of illnesses. While the same ELISA biomarkers can also be used in a range of other industries. This is just one form of bioanalysis – the process of testing for the amount of a substance in a sample – and there are many other tests that can be carried out to establish the presence and quantities of various other substances after clinical sample collection.
The plate will require washing with a detergent between each step which can remove the proteins and antibodies not bound. Afterward, the plate is developed via adding some enzymatic substrate which can create the signal demonstrating the amount of antigen in that sample.
As mentioned, the standard signaling method is a color change which is achieved by using a chromogenic reporter and substrates which create an observable colour change. However ELISA biomarkers have developed somewhat and other methods are now also used. For instance some similar techniques now use fluorogenic materials which glow fluorescent, electrochemilumiscent which also illuminate and real time PCR reporters which show quantifiable signals.
There are certain advantages to using these various kinds of reporters. For instance some of them are more sensitive and multiplexing. Newer assays are not technically ELISAs because the name itself and definition suggests the use of enzymes (‘Enzyme Linked’). However they are linked to other reporters but are otherwise the same.
While it is fairly easy to understand, ELISA biomarkers involve a complex process and most pharmaceutical will outsource these tests.
However the main use of ELISE biomarkers remains in developing antibodies, and testing the body’s own immune response to certain substances. This process is relatively easy to understand. Essentially an unknown quantity of antigen is attached to a surface, before the antibody is applied to the surface in order to bind to the antigen. The antibody meanwhile is also linked to an enzyme, and this then allows for the ELISA biomarkers to be used to signal successful attachment. Normally this will be a simple change in color for the chemical substrate.
An ELISA test then requires one antibody which has a particularity for a specific antigen. Here the sample with the unspecified amount of antigen is immobilized using a solid support.
This will normally be a polystyrene plate. Once this antigen has been immobilized, the detection agent gets added which then forms a complex with the antigen. This detection antibody is either covalently attached to an enzyme, or is itself detectable via a second antibody – and here this is linked to an enzyme via bioconjugation.
ELISA Biomarkers, also known as ELISA or as enzyme immunoassay, is a biochemical and bioanalytical technique used to detect the presence of an antibody or an antigen in a sample. This is used often in immunology of course to test for immune responses and to help develop certain immunizations. ELISA biomarkers are used as diagnostic tool also in medicine, plant pathology and for check ups in various industries.
However ELISA biomarkers are not only used to evaluate the presence of antibodies, but also the presence of antigens. This makes it highly useful for calculating the serum antibody concentrations – as is the case with the HIV test. Further it is also highly useful for testing in the food industry in order to find the amount of allergens in food items. This is highly useful because allergens are simply substances that the body treats as antigens – triggering an immune response that can be unpleasant and in some cases dangerous. While the actual food is harmless then, it’s the antibodies and the immune response of the body that creates the danger.
CRO stands for a Clinical Research Organization which is referred to as a contract research organization. This is an independent organization which is concerned in the conduct of a clinical trial. A CRO then is not a single orgnization, but rather an umbrella term used to describe the organization used in any clinical trial in order to handle data management, communication between sponsors, the coordination of investigators, the investigators themselves (clinical researchers or the physicians) and the Institutional Review Board. The purpose of a CRO is to monitor various clinical phases and provide CRAs (Clinical Research Associates) to do the monitoring for each clinical trial, and then to collect and refine and analyze the data. The CRO will also often own research sites or a single site.
A CRO then can be seen almost as a contractor but for clinical trials of biochemistry and pharmaceuticals. They will be funded by a benefactor, client or organization and will then organize the necessary trials and all involved individuals in order to provide the results.