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, seriousPublish date - 2020Language - englishCOBISS.SI-ID - 4885105
Author
Jereb, Rebeka |
Opara, Jerneja |
Legen, Igor |
Petek, Boštjan |
Grabnar, Darja
Topics
Farmakokinetika |
IVIVC |
PBPK absorption modeling |
bioequivalence |
modified release |
absorpcija učinkovin |
validacija učinkovin
![loading ... loading ...](themes/default/img/ajax-loading.gif)
Shelf entry
Permalink
- URL:
Impact factor
Access to the JCR database is permitted only to users from Slovenia. Your current IP address is not on the list of IP addresses with access permission, and authentication with the relevant AAI accout is required.
Year | Impact factor | Edition | Category | Classification | ||||
---|---|---|---|---|---|---|---|---|
JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Select the library membership card:
If the library membership card is not in the list,
add a new one.
DRS, in which the journal is indexed
Database name | Field | Year |
---|
Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
---|---|
Jereb, Rebeka | 50714 |
Opara, Jerneja | 14105 |
Legen, Igor | 20369 |
Petek, Boštjan | ![]() |
Grabnar, Darja | 20669 |
Source: Personal bibliographies
and: SICRIS
Select pickup location:
Material pickup by post
Delivery address:
Address is missing from the member's data.
The address retrieval service is currently unavailable, please try again.
By clicking the "OK" button, you will confirm the pickup location selected above and complete the reservation process.
By clicking the "OK" button, you will confirm the above pickup location and delivery address, and complete the reservation process.
By clicking the "OK" button, you will confirm the address selected above and complete the reservation process.
Notification
Automatic login and reservation service currently not available. You can reserve the material on the Biblos portal or try again here later.
Subject headings in COBISS General List of Subject Headings
Select pickup location
The material from the parent unit is free. If the material is delivered to the pickup location from another unit, the library may charge you for this service.
Pickup location | Material status | Reservation |
---|
Reservation in progress
Please wait a moment.
Reservation was successful.
Reservation failed.
Reservation...
Membership card:
Pickup location: