get_f2 {disprofas}R Documentation

Get the f2 similarity factor

Description

The function get_f2() calculates the similarity factor f_2 for the assessment of dissolution profiles.

Usage

get_f2(data, ins, tcol, grouping)

Arguments

data

A data frame with the dissolution profile data in wide format.

ins

A vector of indices generated regarding the grouping.

tcol

A vector of indices specifying the columns in data that contain the % release values. The length of tcol must be three or longer.

grouping

A character string specifying the column in data that contains the group names (i.e. a factorial variable, e.g., for the differentiation of batches or formulations of a drug product).

Details

Similarity of dissolution profiles is assessed using the similarity factor f_2 according to the EMA guideline (European Medicines Agency 2010) “On the investigation of bioequivalence”. The evaluation of the similarity factor is based on the following constraints:

  1. A minimum of three time points (zero excluded).

  2. The time points should be the same for the two formulations.

  3. Twelve individual values for every time point for each formulation.

  4. Not more than one mean value of > 85% dissolved for any of the formulations.

  5. The relative standard deviation or coefficient of variation of any product should be less than 20% for the first time point and less than 10% from the second to the last time point.

The similarity factor f_2 is calculated by aid of the equation

f_2 = 50 \times \log \left(\frac{100}{\sqrt{1 + \frac{\sum_{t=1}^{n} \left(\bar{R}(t) - \bar{T}(t) \right)^2}{n}}} \right) .

In this equation

f_2

is the similarity factor,

n

is the number of time points,

\bar{R}(t)

is the mean percent reference drug dissolved at time t after initiation of the study, and

\bar{T}(t)

is the mean percent test drug dissolved at time t after initiation of the study.

Dissolution profiles are regarded as similar if the f_2 value is between 50 and 100.

Value

The function returns the f_2 value.

References

United States Food and Drug Administration (FDA). Guidance for industry: dissolution testing of immediate release solid oral dosage forms. 1997.
https://www.fda.gov/media/70936/download

United States Food and Drug Administration (FDA). Guidance for industry: immediate release solid oral dosage form: scale-up and post-approval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation (SUPAC-IR). 1995.
https://www.fda.gov/media/70949/download

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. 2010; CPMP/EWP/QWP/1401/98 Rev. 1.
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf

See Also

get_f1.


[Package disprofas version 0.1.3 Index]