Biochemical assays in drug development act as analytical models. These models produce signals in the presence of reagents to indicate quantities of certain drug components. Assay quality depends on how reproducible and accurate the model is. This tests if the assay is capable of producing signals to detect the presence of components. These signals indicate radioactivity of a compound, fluorescence or absorbance of a compound. Many things like statistical models, reagents, et cetera impact a biochemical assay. The data collected from such assays helps analyze the pharmacological and biological activities of drug components.
Factors Affecting Biochemical Analysis
It isn’t an easy task at hand to develop an accurate assay for testing drug components. Multiple factors are considered while developing an assay on the course of drug development. Here’s a list of critical factors that affects a biochemical assay.
The source molecule, as the name suggests, is what the drug main drug component is derived from. This, in turn, judges the availability of the sample molecule, its volume, concentration, and stability.
Parameters Of The Assay
These involve laying out the parameters on which the assay will be conducted. This is a broad spectrum involving questions like if the assay is going to be based on the biological functioning or the quantity of the molecule present et cetera.
The Accurate Component
Typically this involves knowing what the component is if it’s an isoform, membrane soluble compound, or membrane-bound. This is one of the most important aspects which can change biochemical assays.
Fundamental Factors Affecting Biochemical Assay Development
The factors mentioned above are practical questions that affect an assay, but there are some which irrespective of the drug component can have an impact on the assay. Here’s a list of those critical factors.
- Flexibility/Robustness- This factor judges whether or not the assay has the capability to adapt to small changes.
- Dynamic Ranging- Will the selected component molecule fall within the chosen range of dynamicity in the assay.
- Specificity- Is the assay-specific enough for detecting the chosen molecule, or will it take into account other molecules as well.
- Precision- How accurate will the assay be in generating desired data?
- Sensitivity- This is one of the key aspects here. It determines whether an assay is capable of detecting the accurate level of molecules in a chosen sample.
How Do These Factors Vary?
Drug development is a process where there are chances of things going horribly wrong and years of research going to waste if you get the biochemical assay wrong. This emphasizes the importance of considering factors that may vary from one component to another. It is a complex process that has multiple factors affecting it. Biochemical assay development, especially in food and drug, deserves extreme focus. It also takes a lot of time to develop an assay if a component is brand new and hasn’t gone through any clinical trials previously. To shorten the time gap, researches are conducted to specify biochemical assays to a group of compounds. But that too comes with its own exceptions.