subject: Bioanalytical Laboratory [print this page] a laboratory where all the tests could be done. But unfortunately, these tests couldnt be done in just any other laboratory; it required a specialized laboratory that was fully equipped with all the necessary things in order to ensure success. As a result, there came the need for Bio analytical Laboratory.
Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bio analysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposureresponse (pharmacokinetics/pharmacodynamics studies). And for this, there is a need for a Bio analytical Laboratory. Bio analysis also applies to drugs used for illicit purposes, forensic investigations, anti-doping testing in sports, and environmental concerns.
Bio analysis was traditionally thought of in terms of measuring small molecule drugs. However, the past twenty years has seen an increase in biopharmaceuticals (e.g. proteins and peptides), which have been developed to address many of the same diseases as small molecules. These larger bio molecules have presented their own unique challenges to quantification. The first studies measuring drugs in biological fluids were carried out to determine possible overdosing as part of the new science of forensic toxicology.
Initially, nonspecific assays were applied to measuring drugs in biological fluids. These were unable to discriminate between the drug and its metabolites; for example, aspirin and sulfonamides were quantified by the use of colorimetric assays. For those of you, who are wondering if I misspelt the word essay, then you are mistaken. An assay is an investigative (analytic) procedure in laboratory medicine and molecular biology for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity which can be a drug or biochemical substance.
Antibiotics were quantified by their ability to inhibit bacterial growth. The 1930s also saw the rise of pharmacokinetics, and as such the desire for more specific assays. Modern drugs are more potent, which has required more sensitive bio analytical assays to accurately and reliably determine these drugs at lower concentrations. This has driven improvements in technology and analytical methods and as a result the rise of the Bio analytical Laboratory.Having read the words Bio analytical Laboratory quite a few times, over the course of this essay, you might be wondering as to what it is. Well, wonder no more. It is a place, establishment, or institution organized and operated primarily for performing chemical, microscopic, serologic, parasitologic, bacteriologic, or other tests, by the practical application of one or more of the fundamental sciences, to material originating from the human body, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health.
Historically, mass spectrometers have been used largely in drug discovery owing to their qualitative capabilities and have escaped rigorous regulation. This is clearly no longer the case. Mass spectrometers are used increasingly as primary detectors in all facets of operations. Many firms conducting internal accounting analyses find that performing GLP bio analysis internally with the help of a Bio analytical Laboratory (as opposed to outsourcing them to contract laboratories) saves both time and money.
This economic efficiency is particularly true for large-sample-number studies because pricing tends to be based upon a per-sample method.The principle rarely extends to contract laboratories performing small-sample-number studies, because smaller numbers of samples often mean that there is not much potential for profit. Consequently, those laboratories sometimes delay a sponsor's small-sample-number studies or assign them a lower priority. This frustrates pharmaceutical sponsors because early studies, no matter how small, can be time-critical, as in the case of toxicology studies.
Compared with a contract laboratory, the results of the internal Bio analytical Laboratory are held accountable more easily for timeliness and compliance. A sponsor can always outsource, but a contract laboratory cannot always subcontract. Moreover, an internal resource that is active in performing GLP bio analysis knows the latest trends in compliance and cost effectiveness. For that reason, such a resource is well-suited to managing external resources, expecting them to implement those trends. And that has been the reason for the meteoric rise in fortune of the Bio analytical Laboratory.
