What is bio-analysis?
Branching out from a significant subdivision of Chemistry, i.e. analytical chemistry, this discipline deals with the quantification of the xenobiotic and biological molecules that make up a drug. This process turns out to be one of the most essential procedures in the medical field to aid in the completion of significant scientific endeavors. A massive chunk on scientific investigations is dependent upon the number of ingredients in the drug.
1- To check whether a certain medicine will not cause any reaction to a particular consumer.
2- For figuring out the rate on which the drug will decompose in the system.
3- Helping to gain perspective about criminal investigations via forensics, doping in games, and many other issues.
Physicians generally opt for one of the popular methods of bio-analysis in the labs around the world. The major names include
2- Nuclear Magnetic Resonance
3- Hyphenated Techniques
4- Mass spectrometry
While some of these techniques are further divided into multiple methods, some are a whole group in themselves. Multiple types of spectrometry, chromatography, and assays are practiced according to the need of the patient or the requirement of the drug that is under study.
To handle these crucial tasks upon which the lives of many innocent people might be dependent, installation of high-functioning and precise instruments becomes something of a necessity. It is vital that the laboratories are not limited to a single location, but more and more testing centers are opened around the societies. This will not only create more chances of skilled people to be hired but also make it possible to accommodate as many knowledgeable people under one roof for more discoveries in the field. Teams consisting of consultants, assistants, researchers, doctors, field experts, and some highly relevant personnel are created for working in the labs to carry out major tasks for the betterment of the medical field and improvement in the ways a task is usually done. Being a research-based organization, our labs are staffed with not only the expert team members and modern machinery but also with the latest services that are important for the completion of bio-analytical tasks. There are two phases of the experiment and both are equally effective. Some tasks need to be performed before the clinical trial begins while others have to be after it. These are biological samples conditioned as preclinical and clinical for the categorization. Each step should be taken correctly to avoid mishaps and give more chances to the success of the trails. Some significant steps that are a part of our laboratory services for bioanalysis include.
This is the first section of the process. To kick start an analysis of drug it is important to plan the procedure first. The method through which the drug will be passed in the coming time to get tested is developed in this phase. Documentation and scope definition is essential to bring all the involved stakeholders on the same page. As it is a very critical situation and lives of people are depending on it, it seems only necessary that the right amount of time is spent on this particular phase to ensure smooth running in the future.
There are two main sections, namely preparation and detection. Preparation work is done in the labs by getting clean extract with focus and determination. Whereas, in the detection phase, the correct detector is selected based on the range of concentration that is in the properties of the analyte.
Once the method is developed, it becomes inevitable to discard the next process. After going through the selection criteria and planning the whole process, it is important to understand if the things that looked good in theory actually have any practical value as well. The lives of people are dependent on these methods, and therefore, it cannot be over or underestimated.
Understanding of using the right tools at the right level of validation shows the credibility of the lab and their potential in the practicing world. There is a certain set of guidelines that are presented by the FDA that should be considered for bio-analytical method validation. Certain methods are recommended for the validation of the drugs as they come with their own set of percentages that ensures the success or failure of the drug. Assay (final product), concentration method, dissolution method, impurity check, and combined method (assay and impurity) are some linearity solutions that are used to test the drugs at labs.
The outcome of these validation processes sets the records straight and ensures that the technicians are aware of the differences between the assumed and actual results.
The analysis phase is the last service of the labs that are dealing with bio-analysis. All the evidence, when once gathered, should be put through the right analysis steps so that the correct sense of data can be formed. To analyze any drug, the lab professionals and everyone on the particular project needs to put in the evidence of drug purity and all the related standards.
The outcomes of this service are a set of tables that contain processed data. Firstly, a summary table filled with information about the drug is structured. All the details about the sample drug like its identification, shipment dates, and collected batch details are listed in this table. Then, a summarized table of all the tests that were run in the clinical and preclinical phase is created. After that, a data table is made that is generally a list of compiled results in one place. The methods and their validation results are of utmost importance as these are the points that are focused on by the other researchers, doctors, and practitioners that have accessed the processed data.
These three are not the only analysis outcomes but if the analysis is repeated at any stage or the project was the reanalysis of an already analyzed sample, then two other tables are created for it.