Description Usage Arguments Value References Examples

Function for testing whether two dissolution profiles are similar concerning the
hypotheses *H_0: \max_{t\in\mathcal{T}} |m_1(t,β_1)-m_2(t,β_2)|≥q ε\ vs.\
H_1: \max_{t\in\mathcal{T}} |m_1(t,β_1)-m_2(t,β_2)|< ε.*

$m_1$ and $m_2$ are pharmacokinetic models chosen from a candidate set containing a First order, Hixson-Crowell,Higuchi, Weibull and a logistic model.

See Moellenhoff et al. (2018) <doi:10.1002/sim.7689> for details.

1 2 |

`time1, time2` |
vectors containing the time points of measurements for each of the two formulations; if not further specified the time points are identical in both groups |

`conc1, conc2` |
data frames or matrices containing the concentrations obtained for each of the two formulations (see the example) |

`m1, m2` |
model types. Built-in models are "firstorder", "hixson", "higuchi", "weibull" and "logistic" |

`epsilon` |
positive argument specifying the equivalence threshold (in %), default is 10% corresponding to an f2 of 50 according to current guidelines |

`B` |
number of bootstrap replications. If missing, default value of B is 1000 |

`plot` |
if TRUE, a plot of the absolute difference curve of the two estimated models will be given. The default is FALSE. |

A list containing the p.value, the types of models, the f2, the maximum absolute difference of the models, the estimated model parameters, the number of bootstrap replications and a summary of the bootstrap test statistic. Furthermore plots of the two models are given.

Moellenhoff et al. (2018) <doi:10.1002/sim.7689>

EMA (2010) <https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf>

1 2 3 4 5 | ```
data(example_data)
conc1 <- select(filter(example_data,Group=="1"),-Tablet,-Group)
conc2 <- select(filter(example_data,Group=="2"),-Tablet,-Group)
time <- c(10,15,20,30,45,60)
sim_test(time1=time,time2=time,conc1=conc1,conc2=conc2,m1="logistic",m2="logistic",B=500,plot=TRUE)
``` |

```
Loading required package: dplyr
Attaching package: ‘dplyr’
The following objects are masked from ‘package:stats’:
filter, lag
The following objects are masked from ‘package:base’:
intersect, setdiff, setequal, union
Loading required package: alabama
Loading required package: numDeriv
Loading required package: mvtnorm
$p.value
[1] 0.092
$types.of.models
[1] "Logistic" "Logistic"
$max.abs.difference
[1] 7.287205
$f2
[1] 70.88722
$estimated.model.param.
[1] -4.049402 1.885921 -5.318727 2.309687
$bootstrap.replications
[1] 500
$summary.boot
Min. 1st Qu. Median Mean 3rd Qu. Max.
4.728 8.638 10.134 10.154 11.575 17.209
```

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