Compare and PASS − Fast screening of oral dosage forms for bioequivalence probability with the COMPASS software

Authors: Danielak, Dorota ^{a, ⁎, 1}, Myslitska, Daria ^a, Winiarski, Maciej ^b, Paszkowska, Jadwiga ^a, Dobosz, Justyna ^a, Staniszewska, Marcela ^a, Smoleński, Michał ^a, Banach, Grzegorz ^a, Garbacz, Grzegorz ^a, Sarcevica, Inese ^c, McAllister, Mark ^c, Arjmandi-Tash, Omid ^d, Romański, Michał ^{e, 1}

Source: In International Journal of Pharmaceutics 10 February 2025 670

Gastric stress events impact the bioavailability of a poorly soluble weak base dabigatran from pellet-filled capsules: An outcome from pharmacokinetic simulations based on biorelevant dissolution testing, machine learning, and a novel timewise first-order dissolution model

Authors: Romański, Michał ^{a, ⁎}, Staniszewska, Marcela ^b, Myslitska, Daria ^b, Paszkowska, Jadwiga ^b, Banach, Grzegorz ^b, Polak, Sebastian ^c, Garbacz, Grzegorz ^b, Danielak, Dorota ^b

Source: In International Journal of Pharmaceutics 15 April 2025 674

Conjunction of semi-mechanistic in vitro-in vivo modeling and population pharmacokinetics as a tool for virtual bioequivalence analysis - a case study for a BCS class II drug

Authors: Danielak, Dorota, Paszkowska, Jadwiga, Staniszewska, Marcela, Garbacz, Grzegorz, Terlecka, Anna, Kubiak, Bartłomiej, Romański, Michał

Source: European journal of pharmaceutics and biopharmaceutics. 186:132-143

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100188336538.0x000001&indx=1&recIds=ETOCvdc_100188336538.0x000001

Application of a novel PhysioCell apparatus for biopredictive dissolution tests of oral immediate release formulations – A case study workflow for in vitro-in vivo predictions

Authors: Romański, Michał ^{a, ⁎, 1}, Staniszewska, Marcela ^b, Paszkowska, Jadwiga ^b, Dobosz, Justyna ^b, Romanova, Svitlana ^b, Pieczuro, Jarosław ^c, Kątny, Michał ^c, Roznerska, Dagmara ^c, Szczepański, Janusz ^c, Schraube, Michał ^c, Renn-Hojan, Monika ^c, Puk, Ewa ^c, Hrem, Oksana ^c, Garbacz, Grzegorz ^b, Danielak, Dorota ^{a, 1}

Source: In International Journal of Pharmaceutics 25 June 2023 641

A Rational Approach to Predicting Immediate Release Formulation Behavior in Multiple Gastric Motility Patterns: A Combination of a Biorelevant Apparatus, Design of Experiments, and Machine Learning †.

Authors: Staniszewska, Marcela¹ (AUTHOR) g.garbacz@physiolution.pl, Romański, Michał² (AUTHOR) michalroman@ump.edu.pl, Polak, Sebastian³ (AUTHOR) sebastian.polak@uj.edu.pl, Garbacz, Grzegorz¹ (AUTHOR) j.dobosz@physiolution.pl, Dobosz, Justyna¹ (AUTHOR) d.myslitska@physiolution.pl, Myslitska, Daria¹ (AUTHOR) s.romanova@physiolution.pl, Romanova, Svitlana¹ (AUTHOR) j.paszkowska@physiolution.pl, Paszkowska, Jadwiga¹ (AUTHOR), Danielak, Dorota² (AUTHOR) danielak@ump.edu.pl

Source: Pharmaceutics. Aug2023, Vol. 15 Issue 8, p2056. 18p.

Subject Terms: *GASTROINTESTINAL motility, *SOLID dosage forms, *MACHINE learning, *EXPERIMENTAL design, *DRUG solubility, *STRAINS & stresses (Mechanics), *RANDOM forest algorithms

Development and Evaluation of Lactose-Free Single-Unit and Multiple-Unit Preparations of a BCS Class II Drug, Rivaroxaban.

Authors: Zakowiecki, Daniel, Edinger, Peter, Papaioannou, Markos, Wagner, Michael, Hess, Tobias, Paszkowska, Jadwiga, Staniszewska, Marcela, Myslitska, Daria, Smolenski, Michal, Dobosz, Justyna, Garbacz, Grzegorz, Haznar Garbacz, Dorota

Source: Pharmaceutics; Nov2024, Vol. 16 Issue 11, p1485, 19p

Subject Terms: BLOOD coagulation, ORAL medication, LACTOSE intolerance, MODERN society, PHYSICAL mobility

More Than a Gut FeelingA Combination of Physiologically Driven Dissolution and Pharmacokinetic Modeling as a Tool for Understanding Human Gastric Motility.

Authors: Romański, Michał, Staniszewska, Marcela, Dobosz, Justyna, Myslitska, Daria, Paszkowska, Jadwiga, Kołodziej, Bartosz, Romanova, Svitlana, Banach, Grzegorz, Garbacz, Grzegorz, Sarcevica, Inese, Huh, Yeamin, Purohit, Vivek, McAllister, Mark, Wong, Suet M., Danielak, Dorota

Source: Molecular Pharmaceutics; 8/5/2024, Vol. 21 Issue 8, p3824-3837, 14p

In VitroSimulation of the Fasted Gastric Conditions and Their Variability to Elucidate Contrasting Properties of the Marketed Dabigatran Etexilate Pellet-Filled Capsules and Loose Pellets

Authors: Staniszewska, Marcela, Myslitska, Daria, Roman´ski, Michal, Polak, Sebastian, Garbacz, Grzegorz, Dobosz, Justyna, Smolen´ski, Michal, Paszkowska, Jadwiga, Danielak, Dorota

Source: Molecular Pharmaceutics; May 2024, Vol. 21 Issue: 5 p2456-2472, 17p

Effect of Compaction Pressure on the Enzymatic Activity of Pancreatin in Directly Compressible Formulations.

Authors: Zakowiecki, Daniel, Edinger, Peter, Hess, Tobias, Paszkowska, Jadwiga, Staniszewska, Marcela, Romanova, Svitlana, Garbacz, Grzegorz

Source: Pharmaceutics; Sep2023, Vol. 15 Issue 9, p2224, 13p

Subject Terms: COMPACTING, CALCIUM phosphate, TABLETING, AMYLASES, BIOMOLECULES, AMYLOLYSIS

PhysioCell^®; — a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics.

Authors: Staniszewska, Marcela, Romanski, Michal, Dobosz, Justyna, Kolodziej, Bartosz, Lipski, Uladzimir, Garbacz, Grzegorz, Danielak, Dorota

Source: AAPS PharmSciTech; Feb2023, Vol. 24 Issue 2, p1-14, 14p

Correction to: PhysioCell®—a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics.

Authors: Staniszewska, Marcela, Romański, Michał, Dobosz, Justyna, Kołodziej, Bartosz, Lipski, Uladzimir, Garbacz, Grzegorz, Danielak, Dorota

Source: AAPS PharmSciTech; Apr2023, Vol. 24 Issue 4, p1-1, 1p