Literature DB >> 34959483

Correction: Mudie et al. In Vitro-In Silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets. Pharmaceutics 2021, 13, 1257.

Deanna M Mudie1, Aaron M Stewart1, Jesus A Rosales1, Molly S Adam1, Michael M Morgen1, David T Vodak1.   

Abstract

The authors wish to make the following corrections to this paper [...].

Entities:  

Year:  2021        PMID: 34959483      PMCID: PMC8704377          DOI: 10.3390/pharmaceutics13122059

Source DB:  PubMed          Journal:  Pharmaceutics        ISSN: 1999-4923            Impact factor:   6.321


The authors wish to make the following corrections to this paper [1]. There was an error in the original article in the Abstract section, where it was stated that the absolute average fold error (AAFE) of the in silico predictions for AUC0-inf for Calquence + famotidine was ≈3. A correction has been made to the abstract section: “In silico simulations of the HPMCAS-H ASD tablet and Calquence capsule provided good in vivo study prediction accuracy using a bottom–up approach (absolute average fold error of AUC0-inf < 2)”. There was an error in the original article in the Results section (Section 3.6, paragraph 1), where it was stated that AAFE of the in silico predictions for AUC0-inf for the Calquence capsule + famotidine treatment was not <2. A correction has been made in the original article in the Results section (Section 3.6, paragraph 1): “The AAFE of the in silico predictions for AUC0-inf, Cmax, Tmax, and Cp versus time for all formulation treatments were <2-fold (ideal value = 1) with the exception of Cp versus time for the Calquence capsule + famotidine treatment, indicating that the in silico prediction framework is sufficient for simulating acalabrutinib blood plasma concentrations within this in vivo study”. In the original article, there were mistakes in Table 4 as published, where AAFE for AUC0-inf for the Calquence capsule + pentagastrin was listed as 1.2 and AAFE for AUC0-inf for Calquence capsule + famotidine was listed as 3.6. The corrected Table 4 appears below.
Table 4

Noncompartmental analysis comparing simulated (sim) versus observed (obs) data for all formulation treatments in the dog study. Absolute average fold error (AAFE) was calculated for AUC0-inf, Cmax, Tmax, and Cp versus time to determine the accuracy of the in silico prediction exercise (ideal value = 1).

FormulationAUC0-inf(ng h/mL)Cmax (ng/mL)Tmax (h)AAFE
ObsSimObsSimObsSimAUC0-infCmaxTmaxCp vs. Time
ASD tablet,pentagastrin81619766333237270.90.91.21.21.61.3
ASD tablet,famotidine75799555344335080.91.61.31.21.81.6
Calquencecapsule,pentagastrin83658607448031100.80.91.11.41.31.3
Calquencecapsule,famotidine311230963556481.61.21.61.91.73.0
The authors apologize for any inconvenience caused and state that the scientific conclusions are unaffected. The original publication has also been updated.
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1.  In Vitro-In Silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets.

Authors:  Deanna M Mudie; Aaron M Stewart; Jesus A Rosales; Molly S Adam; Michael M Morgen; David T Vodak
Journal:  Pharmaceutics       Date:  2021-08-13       Impact factor: 6.321

  1 in total

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