Amount of the active ingredient is sufficient to induce the biological effect. Sub-potent batches can be identified including storage under accelerated conditions as well as forced degradation studies.
Consistency of the DP is ensured, e. View fullsize. Figure 1: Overview on key features of a potency assay. Upfront thinking and strategic planning are essential to decide:. Which assays are required to form a characterization package,. Demonstrate an appropriate link to the intended clinical effect Figure 2.
Depending on the complexity of the product, a combination of multiple methods may be needed to adequately define potency during development Figure 2. Assay methods normally incorporate accurate and precise analytical methods. There are various types of assays. Depending on the sample to be analyzed and the other requirements, you can choose the most appropriate assay type.
Chemical assays are done using techniques like chromatography, titrations, etc. Bioassays are another type of assays carried out to quantify the effect of samples in biological systems. It includes studies of drugs on micro-organisms, virulence studies on human, bioassay of hormones, etc. On the contrary, assays are a type of widely used analyzing methods of samples in pharmacology, laboratory medicine, biochemistry, biotechnology, immunology, environmental biology, etc.
Here, the analyte or the main target component can be a drug, biochemical substance, a cell of an organism or an organic sample. Moreover, assays can be classified based on different aspects. Based on the type and number of measurements taken, there are two types of assays; they are endpoint assays, which measure signals after a fixed incubation time, and kinetic assays, which take measurements multiple times over a fixed time intervals.
Potency is the amount of a drug required to get an effect at its maximum intensity. This means a highly potent drug can give the desired response in a low dose. In contrast, a drug having a low potency gives the desired response at a high dose. The response given for a drug is the effect of the drug on our body. This effect depends on both the binding of the drug with the receptor affinity and the production of the response after the attachment of the drug with a receptor efficacy.
At lower doses of the drug, the effect is also low. When the dose increases, the effect also increases until it reaches the maximum possible effect of the drug. But when the dose is further increased, the effect does not raise. And also even if the dose of the drug is increased, there can be some side effect as well.
I am working for a government regulatory body for pharmaceutical products and this formula always pops up almost automatically everytime when the product being registered has come from India. Do you have any reputable reference to back up you formula?
Why is this methodology only comes from India and also Pakistan? No other country uses this in their product formulation. This is debatable. Hi dear u can see my comment above. You are commenting using your WordPress. You are commenting using your Google account. You are commenting using your Twitter account. You are commenting using your Facebook account.
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