Akademska digitalna zbirka SLovenije - logo
ALL libraries (COBIB.SI union bibliographic/catalogue database)
  • In vitro - in vivo relationship and bioequivalence prediction for modified - release capsules based on a PBPK absorption model [Elektronski vir]
    Jereb, Rebeka ...
    A physiologically based pharmacokinetic (PBPK) absorption model was developed in GastroPlus% based on data on intravenous, immediate-release (IR), and modified-release (MR) drug products. The ... predictability of the model was evaluated by comparing predicted and observed plasma concentration profiles; average prediction errors (PE) were below 10%. IVIVR was developed using mechanistic deconvolution for a MR drug product to evaluate the in vivo effect of a proposed change in dissolution specification. The predictability of the IVIVR was evaluated and PE were below 10%; however, external validation was not possible due to the lack of data. The developed PBPK absorption model and IVIVR were used to predict plasma concentration profiles and pharmacokinetic (PK) parameters for a hypothetical formulation with 0% of drug dissolved in 2 h in in vitro dissolution test. Both methods predicted the insignificant effect of a change in in vitro dissolution profile on in vivo product performance. The bioequivalence of a hypothetical formulation to the test product was evaluated using virtual clinical trial. The performed analysis supported the proposed change in dissolution specification. A validated PBPK absorption model was proposed as an adequate alternative to IVIVC, when IVIVC could not have been developed according to the guidelines.
    Source: AAPS PharmSciTech [Elektronski vir]. - ISSN 1530-9932 (Vol. 21, iss. 1, 2020, str. 1-11)
    Type of material - e-article ; adult, serious
    Publish date - 2020
    Language - english
    COBISS.SI-ID - 4885105

    Link(s):

    https://link.springer.com/article/10.1208%2Fs12249-019-1566-x
    DOI

Shelf entry