Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Autor: Dejan Krajcar, Rebeka Jereb, Igor Legen, Jerneja Opara, Iztok Grabnar

Publikováno v: Drugs in R&D, Vol 23, Iss 3, Pp 211-220 (2023)

Abstract Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development. The objective of this research was to evaluate the associations between so

Externí odkaz: https://doaj.org/article/b5bb7643332d44b7985aa5c0709f9467

Physiologically based absorption modeling to predict bioequivalence of controlled release and immediate release oral products

Autor: Raja Velagapudi, Bostjan Petek, Amitava Mitra, Igor Legen, Aleksander Bajc

Publikováno v: European Journal of Pharmaceutics and Biopharmaceutics. 134:117-125

Physiologically based absorption modeling was conducted to predict bioequivalence (BE) for immediate release (IR) and controlled release (CR) formulations. In case of the CR formulation of a BCS class 1 drug, sensitivity analyses were conducted to in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::80116f1f7799e27faa8ed07bd21a02dc
https://doi.org/10.1016/j.ejpb.2018.11.019

The biorelevant simulation of gastric emptying and its impact on model drug dissolution and absorption kinetics

Autor: Rebeka Jereb, Dejan Krajcar, Helena Vrbanac, Jerneja Opara, Bostjan Petek, Sandra Berglez, Igor Legen, Jurij Trontelj

Publikováno v: European journal of pharmaceutics and biopharmaceutics, str. 113-120 : Ilustr., Vol. 149, 2020
COBISS-ID: 13176839

The highly variable physiological conditions within the gastrointestinal tract can cause variable drug release and absorption from the orally administrated dosage forms. The emptying of the gastric content is one of the most critical physiological pr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b910fd4d96543e526f154b703806d03
https://plus.cobiss.net/cobiss/si/en/bib/4884849

Determining The Pressure-Generating Capacity of The Classical and Alternative In Vitro Dissolution Methods Using a Wireless Motility Capsule

Autor: Jurij Trontelj, Iztok Grabnar, Igor Legen, Melita Hribar, Ognen Jakasanovski

Publikováno v: Journal of Pharmaceutical Innovation. 13:226-236

Purpose In vitro dissolution tests are an important tool for prediction of in vivo behavior of pharmaceutical dosage forms. One of the main reasons behind poor in vitro-in vivo correlation is the lack of knowledge about the true in vivo conditions an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::cedd3d8f8975bd929ff7760db490e275
https://doi.org/10.1007/s12247-018-9317-1

Biopharmaceutical classification of desloratadine - not all drugs are classified the easy way

Autor: Nadica Sibinovska, Simon Žakelj, Jurij Trontelj, Katja Berginc, Igor Legen

Publikováno v: Acta Pharmaceutica
Volume 70
Issue 2
Acta Pharmaceutica, Vol 70, Iss 2, Pp 131-144 (2020)
Acta pharmaceutica, str. 131-144 : Ilustr., Vol. 70, iss. 2, 2020
COBISS-ID: 13497349
Acta pharmaceutica, vol. 70, no. 2, pp. 131-144, 2020.

The biopharmaceutical classification of drugs was designed as a basis for bio-waivers – a mechanism with the double ethical benefit of delivering new drug formulations to the market with less human testing and lower cost. However, many drugs defy s

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::391bf086597ce63bdd49f1a4c4fd5e3a
https://pubmed.ncbi.nlm.nih.gov/31955139