Development of R packages: ‘<i>NonCompart</i>’ and ‘<i>ncar</i>’ for noncompartmental analysis (NCA)

Kim, Hyungsub; Han, Seungjin; Cho, Yong‐Soon; Yoon, Seok-Kyu; Bae, Kyun‐Seop

doi:10.12793/tcp.2018.26.1.10

Cited by 13 publications

(5 citation statements)

References 3 publications

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“…Prior to pharmacokinetic analyses, incomplete time courses were interpolated using multiple imputation chain equations (MICE), derived from the mice (version 3.15.0) package 58 , following no detection of deviation from missing completely at random (MCAR) based on Little’s MCAR test. Preliminary serum area under the curve (AUC) and half-lives were extrapolated using the NonCompart (version 0.6.0) package 59 . All pharmacokinetic analyses were performed in a non-compartmental fashion.…”

Section: Methodsmentioning

confidence: 99%

Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognition

Mallaroni

Mason

Reckweg

et al. 2023

Preprint

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2,5-dimethoxy-4-bromophenethylamine (2C-B) is a hallucinogenic phenethylamine derived from mescaline. Observational and preclinical data have suggested it to be capable of producing both subjective and emotional effects on par with other classical psychedelics and entactogens. Whereas it is the most prevalently used novel serotonergic hallucinogen to date, it′s acute effects and distinctions from classical progenitors have yet to be characterised in a controlled study. We assessed for the first time the immediate acute subjective, cognitive, and cardiovascular effects of 2C-B (20 mg) in comparison to psilocybin (15mg) and placebo in a within-subjects, double-blind, placebo-controlled study of 22 healthy psychedelic-experienced participants. 2C-B elicited alterations of waking consciousness of a psychedelic nature, with dysphoria, subjective impairment, auditory alterations, and affective elements of ego dissolution largest under psilocybin. Participants demonstrated equivalent psychomotor slowing and spatial memory impairments under either compound compared to placebo, as indexed by the Digit Symbol Substitution Test (DSST), Tower of London (TOL) and Spatial Memory Task (SMT). Neither compound produced empathogenic effects on the Multifaceted Empathy Test (MET). 2C-B induced transient pressor effects to a similar degree as psilocybin. The duration of self-reported effects of 2C-B was shorter than that of psilocybin, largely resolving within 6 hours. Present findings support the categorisation of 2C-B as a subjectively ″lighter″ psychedelic. Tailored dose-effect studies are needed to discern the pharmacokinetic dependency of 2C-B′s experiential overlaps.

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Section: Methodsmentioning

confidence: 99%

Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognition

Mallaroni

Mason

Reckweg

et al. 2023

Preprint

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“…NonCompart package (version 0.4.7, by Kyun-Seop Bae, 2020) in R (version 3.6.3; R Foundation for Statistical Computing, Vienna, Austria) was utilized in this procedure. The AUC τ was calculated according to the linear trapezoidal rule [ 10 ]. The t 1/2 was estimated as the value of 0.693/λ z , where λ z is the terminal elimination slope with the best determination coefficient from the linear regression of the last ≥ three observations.…”

Section: Methodsmentioning

confidence: 99%

An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug

Hong

Jeon²,

Choi

et al. 2021

Korean J Physiol Pharmacol

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Fixed-dose combinations development requires pharmacokinetic drugdrug interaction (DDI) studies between active ingredients. For some drugs, pharmacokinetic properties such as long half-life or delayed distribution, make it difficult to conduct such clinical trials and to estimate the exact magnitude of DDI. In this study, the conventional (non-compartmental analysis and bioequivalence [BE]) and modelbased analyses were compared for their performance to evaluate DDI using amlodipine as an example. Raw data without DDI or simulated data using pharmacokinetic models were compared to the data obtained after concomitant administration. Regardless of the methodology, all the results fell within the classical BE limit. It was shown that the model-based approach may be valid as the conventional approach and reduce the possibility of DDI overestimation. Several advantages (i.e., quantitative changes in parameters and precision of confidence interval) of the model-based approach were demonstrated, and possible application methods were proposed. Therefore, it is expected that the model-based analysis is appropriately utilized according to the situation and purpose.

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“…The noncompartmental analysis was conducted using the validated open-source R library -NonCompart‖. 36…”

Section: Softwarementioning

confidence: 99%

“…The data management and graphical presentation of the results were conducted using R language, version 4.0.0. 27 The noncompartmental analysis was conducted using the validated open‐source R library “NonCompart.” 36 …”

Section: Softwarementioning

confidence: 99%

Modeling Complex Pharmacokinetics of Long‐Acting Injectable Products Using Convolution‐Based Models With Nonparametric Input Functions

Goméni

Bressolle-Gomeni

2021

The Journal of Clinical Pharma

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The interest in the development and the therapeutic use of long-acting injectable (LAI) products for chronic or long-term treatments has grown exponentially. The complexity and the multi-phase drug release process represent serious issues for an effective modeling of the PK properties of LAI products. The objective of this paper was to show how convolutionbased models with piecewise-linear approximation of the nonlinear drug release function, can provide an enhanced modeling tool for: a) characterizing the complex PK profiles of LAI formulations with completely different drug release properties, and b) addressing key questions supporting the optimal development of LAI products by simulating the PK time course resulting from different dosing strategies. Convolution-based modeling and simulation were implemented in NONMEM and three case studies were presented to assess the performances of this new modeling approach using PK data of LAI products developed using different technologies and administered using different routes: microsphere technology and aqueous nanosuspension intramuscularly administered, and biodegradable polymer subcutaneously administered. The performance of the convolution-based modeling approach was compared to the performance of conventional parametric models using a reference dataset on theophylline. The results of the comparison indicated that the nonparametric input function provided a more accurate description of the data either in term of global measure of goodness of fit (i.e., AIC and BIC criteria) or in term of performance of the fitted model (i.e., the percent prediction error on Cmax and AUC 0-t).

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Development of R packages: ‘NonCompart’ and ‘ncar’ for noncompartmental analysis (NCA)

Cited by 13 publications

References 3 publications

Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognition

Assessment of the acute effects of 2C-B vs psilocybin on subjective experience, mood and cognition

An experience on the model-based evaluation of pharmacokinetic drug-drug interaction for a long half-life drug

Modeling Complex Pharmacokinetics of Long‐Acting Injectable Products Using Convolution‐Based Models With Nonparametric Input Functions

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