Fraunhofer-Gesellschaft

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Hier finden Sie wissenschaftliche Publikationen aus den Fraunhofer-Instituten.
2021Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality
Mitra, A.; Suarez-Sharp, S.; Pepin, X.J.H.; Flanagan, T.; Zhao, Y.; Kotzagiorgis, E.; Parrott, N.; Sharan, S.; Tistaert, C.; Heimbach, T.; Zolnik, B.; Sjögren, E.; Wu, F.; Anand, O.; Kakar, S.; Li, M.; Veerasingham, S.; Kijima, S.; Lima Santos, G.M.; Ning, B.; Raines, K.; Rullo, G.; Mandula, H.; Delvadia, P.; Dressman, J.; Dickinson, P.A.; Babiskin, A.
Journal Article
2021Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report
Parrott, N.; Suarez-Sharp, S.; Kesisoglou, F.; Pathak, S.M.; Good, D.; Wagner, C.; Dallmann, A.; Mullin, J.; Patel, N.; Riedmaier, A.E.; Mitra, A.; Raines, K.; Butler, J.; Kakhi, M.; Li, M.; Zhao, Y.; Tsakalozou, E.; Flanagan, T.; Dressman, J.; Pepin, X.
Journal Article
2021Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine
Garci­a, M.A.; Cristofoletti, R.; Abrahamsson, B.; Groot, D.W.; Parr, A.; Polli, J.E.; Mehta, M.; Shah, V.P.; Tomakazu, T.; Dressman, J.B.; Langguth, P.
Review
2021Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
Pepin, X.J.H.; Parrott, N.; Dressman, J.; Delvadia, P.; Mitra, A.; Zhang, X.; Babiskin, A.; Kolhatkar, V.; Suarez-Sharp, S.
Journal Article
2021Evaluating the impact of acid-reducing agents on drug absorption using biorelevant in vitro tools and PBPK modeling - case example dipyridamole
Segregur, D.; Barker, R.; Mann, J.; Moir, A.; Karlsson, E.M.; Turner, D.B.; Arora, S.; Dressman, J.
Journal Article
2021Oral biopharmaceutics tools: Recent progress from partnership through the Pharmaceutical Education and Research with Regulatory Links collaboration
O'Dwyer, P.J.; Box, K.J.; Dressman, J.; Griffin, B.T.; Henze, L.J.; Litou, C.; Pentafragka, C.; Statelova, M.; Vertzoni, M.; Reppas, C.
Journal Article
2021Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Support Waivers of In Vivo Clinical Studies: Current Status, Challenges, and Opportunities
Loisios-Konstantinidis, I.; Dressman, J.
Journal Article
2021Prediction of plasma profiles of a weakly basic drug after administration of omeprazole using PBPK modeling
Segregur, D.; Mann, J.; Moir, A.; Karlsson, E.M.; Dressman, J.
Journal Article
2021Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach
Komasaka, T.; Dressman, J.
Journal Article
2021Sustained-release hot melt extrudates of the weak acid TMP-001: A case study using PBB modelling
Jung, F.; Thurn, M.; Krollik, K.; Li, D.; Dressman, J.; Alig, E.; Fink, L.; Schmidt, M.U.; Wacker, M.G.
Journal Article
2020Biorelevant Two-Stage In Vitro Testing for rDCS Classification and in PBPK Modeling - Case Example Ritonavir
Fiolka, T.; Abeele, J. Van Den; Augustijns, P.; Arora, S.; Dressman, J.
Journal Article
2020Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride
Charoo, N.A.; Abdallah, D.B.; Parveen, T.; Abrahamsson, B.; Cristofoletti, R.; Groot, D.W.; Langguth, P.; Parr, A.; Polli, J.E.; Mehta, M.; Shah, V.P.; Tajiri, T.; Dressman, J.
Journal Article
2020Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate
Plöger, G.F.; Quizon, P.M.; Abrahamsson, B.; Cristofoletti, R.; Groot, D.W.; Parr, A.; Langguth, P.; Polli, J.E.; Shah, V.P.; Tajiri, T.; Mehta, M.U.; Dressman, J.
Journal Article
2020Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions
Pentafragka, C.; Vertzoni, M.; Dressman, J.; Symillides, M.; Goumas, K.; Reppas, C.
Journal Article
2020Combining biorelevant in vitro and in silico tools to investigate the in vivo performance of the amorphous solid dispersion formulation of etravirine in the fed state
Litou, C.; Turner, D.B.; Holmstock, N.; Ceulemans, J.; Box, K.J.; Kostewicz, E.; Kuentz, M.; Holm, R.; Dressman, J.
Journal Article
2020Dissolution behavior of various drugs in different FaSSIF versions
Klumpp, L.; Leigh, M.; Dressman, J.
Journal Article
2020Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV
Reppas, C.; Vrettos, N.-N.; Dressman, J.; Andreas, C.J.; Miyaji, Y.; Brown, J.; Etherson, K.; Hanley, S.; Karkossa, F.; Karlsson, E.; Klein, S.; Maier, G.-M.; McAllister, M.; Mistry, N.; Rosenblatt, K.; Schäfer, K.J.; Smith, K.L.; Tomaszewska, I.; Williams, J.; Winge, F.; Vertzoni, M.
Journal Article
2020Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen
Loisios-Konstantinidis, I.; Cristofoletti, R.; Fotaki, N.; Turner, D.B.; Dressman, J.
Journal Article
2020Evaluation of Differences in Dosage Form Performance of Generics Using BCS-Based Biowaiver Specifications and Biopharmaceutical Modeling
Hofsäss, M.A.; Dressman, J.
Journal Article
2020Incorporation of HPMCAS during loading of glibenclamide onto mesoporous silica improves dissolution and inhibits precipitation
Price, D.J.; Nair, A.; Becker-Baldus, J.; Glaubitz, C.; Kuentz, M.; Dressman, J.; Saal, C.
Journal Article
2020Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers
Mansuroglu, Y.; Dressman, J.
Journal Article
2020Measuring pH and Buffer Capacity in Fluids Aspirated from the Fasted Upper Gastrointestinal Tract of Healthy Adults
Litou, C.; Psachoulias, D.; Vertzoni, M.; Dressman, J.; Reppas, C.
Journal Article
2020Physiologically based pharmacokinetic model outputs depend on dissolution data and their input
Klumpp, L.; Dressman, J.
Journal Article
2020Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen
Loisios-Konstantinidis, I.; Cristofoletti, R.; Jamei, M.; Turner, D.; Dressman, J.
Journal Article
2020Suitability of the z-Factor for Dissolution Simulation of Solid Oral Dosage Forms
Hofsäss, M.A.; Dressman, J.
Journal Article
2020The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets
Paraiso, R.L.M.; Rose, R.H.; Fotaki, N.; McAllister, M.; Dressman, J.B.
Journal Article
2019Application of a Refined Developability Classification System
Rosenberger, J.; Butler, J.; Muenster, U.; Dressman, J.
Journal Article
2019Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review
Loisios‐Konstantinidis, I.; Paraiso, R.L.M.; Fotaki, N.; McAllister, M.; Cristofoletti, R.; Dressman, J.
Journal Article
2019Biorelevant dissolution testing of a weak base: Interlaboratory reproducibility and investigation of parameters controlling in vitro precipitation
Berben, P.; Ashworth, L.; Beato, S.; Bevernage, J.; Bruel, J.-L.; Butler, J.; Dressman, J.; Schäfer, K.; Hutchins, P.; Klumpp, L.; Mann, J.; Nicolai, J.; Ojala, K.; Patel, S.; Powell, S.; Rosenblatt, K.; Tomaszewska, I.; Williams, J.; Augustijns, P.
Journal Article
2019Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations
Price, D.J.; Nair, A.; Kuentz, M.; Dressman, J.; Saal, C.
Journal Article
2019Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states
Litou, C.; Patel, N.; Turner, D.B.; Kostewicz, E.; Kuentz, M.; Box, K.J.; Dressman, J.
Journal Article
2019Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes
Segregur, D.; Flanagan, T.; Mann, J.; Moir, A.; Karlsson, E.M.; Hoch, M.; Carlile, D.; Sayah-Jeanne, S.; Dressman, J.
Journal Article
2019In‐vitro–in‐silico investigation of the negative food effect of zolpidem when administered as immediate‐release tablets
Paraiso, R.L.M.; Watanabe, A.; Andreas, C.J.; Turner, D.; Zane, P.; Dressman, J.
Journal Article
2019Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach
Cristofoletti, R.; Hens, B.; Patel, N.; Esteban, V.V.; Schmidt, S.; Dressman, J.
Journal Article
2019A novel in vivo predictive dissolution testing coupled with a modeling and simulation for hydrogel matrix monolithic extended release oral dosage forms
Kambayashi, A.; Dressman, J.B.
Journal Article
2019Opportunities for Successful Stabilization of Poor Glass-Forming Drugs: A Stability-Based Comparison of Mesoporous Silica Versus Hot Melt Extrusion Technologies
Ditzinger, F.; Price, D.J.; Nair, A.; Becker-Baldus, J.; Glaubitz, C.; Dressman, J.; Saal, C.; Kuentz, M.
Journal Article
2019PBPK modeling coupled with biorelevant dissolution to forecast the oral performance of amorphous solid dispersion formulations
Kambayashi, A.; Kiyota, T.; Fujiwara, M.; Dressman, J.
Journal Article
2019Predicting the Changes in Oral Absorption of Weak Base Drugs Under Elevated Gastric pH Using an In Vitro-In Silico-In Vivo Approach
Kambayashi, A.; Dressman, J.B.
Journal Article
2019Stability of Biorelevant Media Under Various Storage Conditions
Klumpp, L.; Nagasekar, K.; McCullough, O.; Seybert, A.; Ashtikar, M.; Dressman, J.
Journal Article
2019Surface Activity Profiling (SAP): A potential means of predicting intestinal membrane permeability
Rosenberger, J.; Schmid, K.; Schäfer, K.J.; Dressman, J.
Journal Article
2018Approaches to increase mechanistic understanding and aid in the selection of precipitation inhibitors for supersaturating formulations
Price, D.J.; Ditzinger, F.; Koehl, N.J.; Jankovic, S.; Tsakiridou, G.; Nair, A.; Holm, R.; Kuentz, M.; Dressman, J.; Saal, C.
Journal Article
2018Development, current applications and future roles of biorelevant two‐stage in vitro testing in drug development
Fiolka, T.; Dressman, J.
Journal Article
2018The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review
Pentafragka, C.; Symillides, M.; McAllister, M.; Dressman, J.; Vertzoni, M.; Reppas, C.
Journal Article
2018An in silico approach to determine challenges in the bioavailability of ciprofloxacin, a poorly soluble weak base with borderline solubility and permeability characteristics
Hansmann, S.; Miyaji, Y.; Dressman, J.
Journal Article
2018In vitro methods to assess drug precipitation in the fasted small intestine
O'Dwyer, P.J.; Litou, C.; Box, K.J.; Dressman, J.; Kostewicz, E.S.; Kuentz, M.; Reppas, C.
Journal Article
2017The dispersion releaser technology is an effective method for testing drug release from nanosized drug carriers
Janas, C.; Mast, M.P.; Kirsamer, L.; Angioni, C.; Gao, F.; Mäntele, W.; Dressman, J.; Wacker, M.G.
Journal Article