TY  - JOUR
AU  - Kovacević, Ivan
AU  - Parojčić, Jelena
AU  - Tubić-Grozdanis, Marija
AU  - Langguth, Peter
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1239
AB  - The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based solely on the in vitro dissolution data, i.e., which would be eligible for biowaiver. On the basis of BCS, currently, the biowaiver concept is adopted and recommended for immediate release of drug products containing highly soluble and highly permeable compounds (BCS class 1 drugs). Dissolution testing properties are proposed to be more stringent: very rapid dissolution is demanded when generic drug application is submitted with the exemption of in vivo bioequivalence study. In the present paper, Gastrointestinal Simulation Technology has been applied in order to evaluate the potential for different in vitro drug dissolution kinetics to influence dosage forms in vivo behavior and the relevance of "very rapid dissolution" criteria to be met (i.e., more than 85% of dose dissolved in 15 min).
PB  - Springer, New York
T2  - AAPS Journal
T1  - An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology
VL  - 11
IS  - 2
SP  - 381
EP  - 384
DO  - 10.1208/s12248-009-9114-3
ER  - 

@article{
author = "Kovacević, Ivan and Parojčić, Jelena and Tubić-Grozdanis, Marija and Langguth, Peter",
year = "2009",
abstract = "The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based solely on the in vitro dissolution data, i.e., which would be eligible for biowaiver. On the basis of BCS, currently, the biowaiver concept is adopted and recommended for immediate release of drug products containing highly soluble and highly permeable compounds (BCS class 1 drugs). Dissolution testing properties are proposed to be more stringent: very rapid dissolution is demanded when generic drug application is submitted with the exemption of in vivo bioequivalence study. In the present paper, Gastrointestinal Simulation Technology has been applied in order to evaluate the potential for different in vitro drug dissolution kinetics to influence dosage forms in vivo behavior and the relevance of "very rapid dissolution" criteria to be met (i.e., more than 85% of dose dissolved in 15 min).",
publisher = "Springer, New York",
journal = "AAPS Journal",
title = "An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology",
volume = "11",
number = "2",
pages = "381-384",
doi = "10.1208/s12248-009-9114-3"
}

Kovacević, I., Parojčić, J., Tubić-Grozdanis, M.,& Langguth, P.. (2009). An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology. in AAPS Journal
Springer, New York., 11(2), 381-384.
https://doi.org/10.1208/s12248-009-9114-3

Kovacević I, Parojčić J, Tubić-Grozdanis M, Langguth P. An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology. in AAPS Journal. 2009;11(2):381-384.
doi:10.1208/s12248-009-9114-3 .

Kovacević, Ivan, Parojčić, Jelena, Tubić-Grozdanis, Marija, Langguth, Peter, "An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology" in AAPS Journal, 11, no. 2 (2009):381-384,
https://doi.org/10.1208/s12248-009-9114-3 . .

TY  - JOUR
AU  - Kovacević, Ivan
AU  - Parojčić, Jelena
AU  - Homšek, Irena
AU  - Tubić-Grozdanis, Marija
AU  - Langguth, Peter
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1252
AB  - The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate compound. Gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus was used. Actual in vitro and in vivo data generated in CBZ bioequivalence studies were used for correlation purposes. The simulated plasma profile, based on the CBZ physicochemical and pharmacokinetic properties, was almost identical with that observed in vivo. Parameter sensitivity analysis (PSA) indicated that the percent of drug absorbed is relatively insensitive to the variation of the input parameters. Additionally, plasma concentration-time profiles were simulated based on dissolution profiles observed under the different experimental conditions. Regardless of the differences observed in vitro, the predicted pharmacokinetic profiles were similar in the extent of drug exposure (AUC) while there were certain differences in parameters defining the drug absorption rate (C-max, t(max)). High level A IVIVC was established for the pooled data set (r = 0.9624), indicating that 1% SLS may be considered as the universal biorelevant dissolution medium for both the IR and CR CBZ tablets. The proposed methodology involving gastrointestinal simulation technology and IVIVC suggests that there is a rationale for considering CBZ biowaiver extension and introduction of the wider dissolution specifications for CBZ immediate release tablets.
PB  - Amer Chemical Soc, Washington
T2  - Molecular Pharmaceutics
T1  - Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation
VL  - 6
IS  - 1
SP  - 40
EP  - 47
DO  - 10.1021/mp800128y
ER  - 

@article{
author = "Kovacević, Ivan and Parojčić, Jelena and Homšek, Irena and Tubić-Grozdanis, Marija and Langguth, Peter",
year = "2009",
abstract = "The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate compound. Gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus was used. Actual in vitro and in vivo data generated in CBZ bioequivalence studies were used for correlation purposes. The simulated plasma profile, based on the CBZ physicochemical and pharmacokinetic properties, was almost identical with that observed in vivo. Parameter sensitivity analysis (PSA) indicated that the percent of drug absorbed is relatively insensitive to the variation of the input parameters. Additionally, plasma concentration-time profiles were simulated based on dissolution profiles observed under the different experimental conditions. Regardless of the differences observed in vitro, the predicted pharmacokinetic profiles were similar in the extent of drug exposure (AUC) while there were certain differences in parameters defining the drug absorption rate (C-max, t(max)). High level A IVIVC was established for the pooled data set (r = 0.9624), indicating that 1% SLS may be considered as the universal biorelevant dissolution medium for both the IR and CR CBZ tablets. The proposed methodology involving gastrointestinal simulation technology and IVIVC suggests that there is a rationale for considering CBZ biowaiver extension and introduction of the wider dissolution specifications for CBZ immediate release tablets.",
publisher = "Amer Chemical Soc, Washington",
journal = "Molecular Pharmaceutics",
title = "Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation",
volume = "6",
number = "1",
pages = "40-47",
doi = "10.1021/mp800128y"
}

Kovacević, I., Parojčić, J., Homšek, I., Tubić-Grozdanis, M.,& Langguth, P.. (2009). Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation. in Molecular Pharmaceutics
Amer Chemical Soc, Washington., 6(1), 40-47.
https://doi.org/10.1021/mp800128y

Kovacević I, Parojčić J, Homšek I, Tubić-Grozdanis M, Langguth P. Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation. in Molecular Pharmaceutics. 2009;6(1):40-47.
doi:10.1021/mp800128y .

Kovacević, Ivan, Parojčić, Jelena, Homšek, Irena, Tubić-Grozdanis, Marija, Langguth, Peter, "Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation" in Molecular Pharmaceutics, 6, no. 1 (2009):40-47,
https://doi.org/10.1021/mp800128y . .

TY  - CONF
AU  - Kovacević, Ivan
AU  - Parojčić, Jelena
AU  - Tubić-Grozdanis, Marija
AU  - Langguth, Peter
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1194
PB  - Taylor & Francis Inc, Philadelphia
C3  - Drug Metabolism Reviews
T1  - Physiologically Based In Silico Prediction of Intestinal Drug Absorption Used as a Tool to Justify the Waiver of In Vivo Bioequivalence Studies
VL  - 41
SP  - 59
EP  - 59
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1194
ER  - 

@conference{
author = "Kovacević, Ivan and Parojčić, Jelena and Tubić-Grozdanis, Marija and Langguth, Peter",
year = "2009",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Drug Metabolism Reviews",
title = "Physiologically Based In Silico Prediction of Intestinal Drug Absorption Used as a Tool to Justify the Waiver of In Vivo Bioequivalence Studies",
volume = "41",
pages = "59-59",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1194"
}

Kovacević, I., Parojčić, J., Tubić-Grozdanis, M.,& Langguth, P.. (2009). Physiologically Based In Silico Prediction of Intestinal Drug Absorption Used as a Tool to Justify the Waiver of In Vivo Bioequivalence Studies. in Drug Metabolism Reviews
Taylor & Francis Inc, Philadelphia., 41, 59-59.
https://hdl.handle.net/21.15107/rcub_farfar_1194

Kovacević I, Parojčić J, Tubić-Grozdanis M, Langguth P. Physiologically Based In Silico Prediction of Intestinal Drug Absorption Used as a Tool to Justify the Waiver of In Vivo Bioequivalence Studies. in Drug Metabolism Reviews. 2009;41:59-59.
https://hdl.handle.net/21.15107/rcub_farfar_1194 .

Kovacević, Ivan, Parojčić, Jelena, Tubić-Grozdanis, Marija, Langguth, Peter, "Physiologically Based In Silico Prediction of Intestinal Drug Absorption Used as a Tool to Justify the Waiver of In Vivo Bioequivalence Studies" in Drug Metabolism Reviews, 41 (2009):59-59,
https://hdl.handle.net/21.15107/rcub_farfar_1194 .