What is parallelism in bioassay?

What is parallelism in bioassay?

Parallelism in bioassay is a synonym of similarity between two concentration-response curves. Before the determination of relative potency in bioassays, it is necessary to test for and claim parallelism between the pair of concentration-response curves of reference standard and test sample.

How do you measure parallelism?

In particular three common methods for parallelism testing are reviewed: two significance tests (the F-test, the \chi^2 -test) and an equivalence test. Simulation is used to compare these methods.

What is bioassay potency?

Relative potency is a term used in bioassay to refer to the ability of a test sample, of unknown potency, to produce the desired response compared to a reference sample, when tested under the same conditions. Relative Potency=DoseStandard sample / DoseTest sample when the 2 doses produce the same effect.

How do you interpret potency?

The value of a drug’s potency should be stated in terms of a dose, i.e. in units of weight….Potency

1. Both Drug A and Drug B achieve the same maximum effect, i.e. they have equal efficacy.
2. However, drug A achieves this effect at a lower dose.
3. Thus, Drug A has higher potency than Drug B.

What is bioassay method?

A bioassay is an analytical method to determine the concentration or potency of a substance by its effect on living animals or plants (in vivo), or on living cells or tissues(in vitro). A bioassay may be used to detect biological hazards or to give an assessment of the quality of a mixture.

What is parallel-line analysis?

Parallel-line assays are common in drug efficacy testing wherein one or more test substances are compared against a reference substance based on their relative potency. Parallel-line analysis (PLA) is the statistical way to assess if curves are parallel, and if so, calculates the relative potencies of the substances.

What is parallelism in drawing?

Parallelism is a fairly common symbol that describes a parallel orientation of one referenced feature to a datum surface or line. It can reference a 2D line referenced to another element, but more commonly it relates the orientation of one surface plane parallel to another datum plane in a 3-Dimensional tolerance zone.

What is parallelism in method validation?

“Parallelism is a performance characteristic that is typically evaluated. during in-study validation. It is conceptually similar to dilutional linearity. except that it is assessed with multiple dilutions of actual study samples or. samples that represent the same matrix and analyte combination as those.

What does potency mean in pharmacology?

Results: Potency is an expression of the activity of a drug in terms of the concentration or amount of the drug required to produce a defined effect, whereas clinical efficacy judges the therapeutic effectiveness of the drug in humans.

What does the standard of potency refer to?

In the field of pharmacology, potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity.

What is the difference between potency and assay?

The key difference between assay and potency is that an assay is the testing of a material to determine its ingredients and quality whereas potency is the amount of a drug required to get an effect at its maximum intensity.

How are bioassays used to estimate relative potency?

Relative potency bioassays are used to estimate the potency of a test biological product relative to a standard or reference product. It is established practice to assess the parallelism of the dose response curves of the products prior to calculating relative potency. This paper provides a review of parallelism testing for bioassays.

Which is the best way to assess parallelism in bioassay?

There has recently been much debate about the best way to assess parallelism in bioassay. There are two distinct philosophical approaches. In the first, similarity is assumed and evidence to contradict this assumption is sought.

What kind of assays are used for potency testing?

Various procedures, including animal-based assays, ligand and receptor binding assays, cell culture-based assays, or other biochemical assays (such as enzymatic assays), may be used for potency testing based on the mechanism of action of the product.

Is there an equivalent approach to potency testing?

In recent years, there has been a move in the potency testing field towards the “Equivalence Testing” approach. In the new USP bioassay chapters (<1032>, <1033>, and <1034>), theoretical advantages, practical challenges as well as several recommended approaches for implementing the Equivalent Testing are well described.