Blume H,
Wedemeyer R-S,
Seidlitz A,
Beuerle G,
Klein S,
Bilensoy E
Open forum conference on the ICH M13A bioequivalence guideline
European Journal of Pharmaceutical Sciences 196, 106741, May 2024
Mehta M, Schug B, Blume HH, Beuerle G, Jiang W, Koenig J, Paixao P, Tampal N, Tsang Y-C, Walstab J, Wedemeyer R, Welink J
The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference
Eur J Pharma Sci 190, 11 2023
Labenz J,
Anschütz M,
Walstab J,
Wedemeyer R-S,
Wolters H,
Schug B
Heartburn relief with bicarbonate-rich mineral water: results of the randomised, placebo-controlled phase-III trial STOMACH STILL
BMJ Open Gastroenterol;10(1):e001048; 2023 Feb
Labenz J,
Anschütz M,
Walstab J,
Donath F,
Wedemeyer R-S,
Wolters H,
Schug B
Healing Water Leads to Reduction of Heartburn: Randomised, Placebo-Controlled Phase-III Trial (Stomach Still)
UEG Week 2022 - Poster Presentations - Oesophageal, gastric and duodenal disorders, P0071, United European Gastroenterology Journal 2022, Vol 10 Abstract Book (S 513-514)
Schurad B,
Koch C,
Schug B,
Morte A,
Vaqué A,
De la Torre R,
Iniesta M
Comparative Bioavailability study of a Novel Multi-day Patch Formulation of Rivastigmine (twice weekly) with Exelon® Transdermal Patch (daily). A randomized clinical trial
Curr Alzheimer Res . 2022 Aug 23.
Morte A,
Vaqué A,
Iniesta M,
Schug B,
Koch C,
De la Torre R,
Schurad B
Bioavailability Study of a Transdermal Patch Formulation of Rivastigmine Compared with Exelon in Healthy Subjects
European Journal of Drug Metabolism and Pharmacokinetics; 2022 Jul;47(4):567-578
Boettcher M,
Mikus G,
Trenk D,
Düngen HD,
Donath F,
Werner N,
Karakas M,
Besche N,
Schulz-Burck D,
Gerrits M,
Hung J,
Becker C
Vericiguat in combination with isosorbide mononitrate in patients with chronic coronary syndromes: The randomized, phase Ib, VISOR study.
Clin Transl Sci. 2022 Mar 17. doi: 10.1111/cts.13238.
Boettcher M,
Düngen HD,
Donath F,
Mikus G,
Werner N,
Thuermann PA,
Karakas M,
Besche N,
Koch T,
Gurniak M,
Becker C
Vericiguat in Combination with Short-Acting Nitroglycerin in Patients With Chronic Coronary Syndromes: The Randomized, Phase Ib, VENICE Study
Clin Pharmacol Ther. 2022 Mar 8. doi: 10.1002/cpt.2574
Duijkers I J M,
Klipping C,
Rautenberg T,
Schug B,
Kochar P S,
Osterwald H,
Oettel M
Effect on ovarian activity and ovulation inhibition of different oral dosages of levonorgestrel
Contraception 110; 6-15, 2022
Donath F,
Hoffmann L,
Todorova-Sanjari M,
Wedemeyer R-S,
Warnke A,
Nickisch K
Intravaginal Tolterodine Formulation Intended for Overactive Bladder Treatment—Results of a Pharmacokinetic Phase I Pilot Study in Healthy, Postmenopausal Women
Clinical Pharmacology in Drug Development 2022, 11(1) 80–90, © 2021 The American College of Clinical Pharmacology
Neumann M,
Heimhardt C,
Seidlitz K,
Koziolek M,
Schneider F,
Schiller C,
Hanke U,
Anschütz M,
Knopke C,
Donath F,
Thoma R,
Brätter C,
Schug C,
Franke H,
Weitschies W
Development of a furosemide-containing expandable system for gastric retention
Journal of Controlled Release 338 (2021) 105–118
Blume HH,
Mehta M,
Beuerle G,
Dorantes A,
Hempel G,
Jiang W,
Kovar A,
Lee J,
Potthast H,
Schug B,
Seidlitz A,
Tampal N,
Y-C Tsang,
Walstab J,
Welink J
The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference
European Journal of Pharmaceutical Sciences Volume 167, 2021
Richter M, Donath F, Wedemeyer R-S, Warnke A, Horstmann A, Peschel C
Pharmacokinetics of oral pridinol: Results of a randomized, crossover bioequivalence trial in healthy subjects
Int J Clin Pharmacol Ther. 2021 Jun; 59(6): 471–477
de Jesus Antunes N, de Oliveira Filho R V, de Oliveira Ilha J, Moreno R A, Nahoum A F, Wedemeyer R-S, Warnke A, De Nucci G
Single-dose pharmacokinetics and pharmacodynamics assessment of oestriol and trimegestone containing vaginal rings in healthy women with childbearing potential
The European Journal of Contraception & Reproductive Health Care, Published online: 01 Mar 2021
Ruggieri A,
Picollo R,
Del Vecchio A,
Calisti F,
Dragone P,
Comandini A,
Rosignoli MT,
Cattaneo A,
Donath F,
Wedemeyer RS,
Todorova-Sanjari M,
Warnke A,
Blume HH
Investigations on dose proportionality and drug-drug interaction for a fixed-dose combination of trazodone and gabapentin
Int J Clin Pharmacol Ther. 2021 Jan;59(1):71-86. doi: 10.5414/CP203845
Rengelshausen J,
Breithaupt‑Groegler K,
Donath F,
Erb‑Zohar K,
Hardman T,
Mikus G,
Plassmann S,
Wensing G,
Sourgens H,
How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum
Therapeutic Innovation & Regulatory Science 3: 1-7, 2021
Duijkers I M,
Klipping C,
Draeger C,
Schug B S,
Dax A,
Friedrich M,
Nickisch K
Ovulation inhibition with a new vaginal ring containing trimegestone
Contraception 102 (2020) 237–242
Duijkers IJM, Klipping C, Draeger C, Schug B, Wedemeyer R-S, Li Y, Arjona Ferreira JC, Migoya EM,
Inhibition of ovulation during co-administration of the once-daily, oral gonadotropin-releasing hormone receptor antagonist, Relugolix, with estradiol and norethindrone acetate in healthy premenopausal women
ESHRE - European Society of Human Reproduction and Embryology, (virtual) 36th Annual Meeting, 5-8 July 2020
Mehta M, Blume H, Beuerle G, Tampal N, Schug BS, Potthast H, Jiang W, Wilson C
The Global Bioequivalence Harmonisation Initiative: Report of EUFEPS/AAPS Third Conference
Eur J Pharma Sci online, 2020
Tellone V, Dragone P, Picollo R, Rosignoli MT, Garofolo F, Del Vecchio A, Calisti F, Comandini A, Donath F, Schug B, Wedemeyer R-S
A novel rizatriptan oral gel formulation: Bioavailability and bioequivalence
Int J Clin Pharmacol Ther. 2020 Oct; 58(10):583-594. doi: 10.5414/CP203652. PMID: 32716291 Clinical Trial.
Boettcher M, Mikus G, Trenk D, Duengen H-D, Donath F, Werner N, Karakas M, Besche N, Schulz-Burck D, Gerrits M, Hung J, Becker C
EACPT-1298: Tolerability and blood pressure effects of a long-acting nitrate co-administered with vericiguat: results of the vericiguat isosorbide mononitrate interaction (visor) study
EACPT 2019, Stockholm, Sweden, 29 June - 2 July, 2019
De Oliveira Filho RV, De Jesus Antunes N, De Oliveira Ilha J, Moreno RA, Wedemeyer R-S, Warnke A, De Nucci G
Pharmacokinetics and pharmacodynamics of three dosages of oestriol after continuous vaginal ring administration for 21 days in healthy, postmenopausal women
British Journal of Clinical Pharmacology 2019 Mar; 85(3):551-562. doi: 10.1111/bcp.13822. Epub 2018 Dec 25.
Chena M-L,
Blume H,
Beuerle G,
Mehta M,
Potthast H,
Brandt A,
Schug B,
Ducharme M,
Endrenyi L,
Gallicano K,
Donald Schuirmanna, Jan Welink
Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence
European Journal of Pharmaceutical Sciences 127, 24-28, Jan 2019
Chen M-L, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, Schug B, Tsang YC, Wedemeyer R-S, Weitschies W, Welink J
The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference
European Journal of Pharmaceutical Sciences 111 (2018): 153-157
Donath F, Armogida M, Shneyer L
A randomized, open-label, crossover study evaluating bioequivalence of two N-acetylcysteine 2% oral solution formulations in healthy subjects
Int J Clin Pharmacol Ther. 2018 Sep;56(9):417-425. doi: 10.5414/CP203128. PMID: 29956648 Clinical Trial
Zimmermann T, Höchel J, Becka M, Boettger MK, Rohde B, Schug B, Kunert KS, Donath F
Topical administration of regorafenib eye drops: phase I dose-escalation study in healthy volunteers
British Journal of Clinical Pharmacology 2018 May; 84(5):865-875. doi: 10.1111/bcp.13502. Epub 2018 Mar 1
Donath F, Grinienko A, Mallefet P, Ozun MJ, Shneyer L
Evaluation of the warming sensation, acceptability, and local tolerability of an acetylcysteine oral solution containing the flavoring agent IFF flavor 316282 in the treatment of productive cough
Int J Clin Pharmacol Ther. 2018 Apr; 56(4):155-161. doi: 10.5414/CP203125. PMID: 29451469 Free PMC article
Donath F, Mallefet P, Ganeffa S, Furcha R
Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixedcombination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study
Trials. 2018 Dec 12;19(1):679. doi: 10.1186/s13063-018-3077-6; (2018)
Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A
Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study
Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4; (2017)
Duengen H-D, Donath F, Mikus G, Werner N, Thuermann PA, Karakas M, Weimann B, Koch T, Boettcher M-F, Becker C
VEriciguat NItroglycerin Clinical IntEraction (VENICE): a phase 1, multicenter, randomized, placebo-controlled, double-blind group-comparison study in patients with stable coronary artery disease to evaluate tolerability and blood pressure effects of nitroglycerin after pre-treatment with multiple oral doses of vericiguat
Journal Circulation, Nov 14, 2017, vol 136 Issue Suppl_1; A19938, (2017)
Boettcher MF, Mikus G, Trenk D, Duengen H-D, Donath F, Werner N, Karakas M, Besche N, Schulz-Burck D, Gerrits M, Hung J, Becker C
Pharmacodynamic Effects Of The Vericiguat ISOsoRbide Mononitrate Interaction (VISOR) Study In Stable CAD Patients
Journal Circulation, Nov 14, 2017, vol 136 Issue Suppl_1; A19938, (2017)
Breithaupt-Groegler K, Coch C, Coenen M, Donath F, Erb-Zohar K, Francke K, Goehler K, Iovino M, Kammerer KP, Mikus G, Rengelshausen J, Sourgens H, Schinzel R, Sudhop T, Wensing G
Who is a ‚healthy subject‘? – consensus results on pivotal eligibility criteria for clinical trials
Eur J Clin Pharmacol. 2017 Apr;73(4):409-416. doi: 10.1007/s00228-016-2189-8. Epub 2017 Jan 7. PMID: 28064353 Free PMC article. Review
Koch C, Dax A, Warnke A, Pauly L, Reichart S*, Pestana EA, Stover J, Lekkos K
Dispensing a high caloric, high protein oral nutritional supplement 3 times daily is well tolerated and increase compliance
ESPEN 2017
Koch C, Dax A, Schug B, Pauly L, Reichart S*, Stover J, Pestana EA, Lekkos K
New high protein and high enegy oral nutritional supplement for compliance and tolerance in elderly care
ESPEN 2017
Wedemeyer R-S, Blume H
NSAIDs: drug group woth relevant need for galenic improvement
Pharmakon 5 (1): 21-31, 2017
Donath F, Tonner F, Chavda R, Gatignol JP, Bouyrie J
Randomized trial of the efficacy and safety of a new oral spray for drug-induced xerostomia
Clin Exp Dent Res: 1-9, 2016
Blume HH, Wedemeyer RS, Donath F, Roscher K, Elvert G, Wagner D, Bley O, Vuia A, Todorova-Sanjari M, Villalobos R, Schug B
Relative bioavailability of a newly developed 5-mg levomethadone hydrochloride IR tablet (L-Polamidon® 5 mg tablets) in comparison with the 5-mg levomethadone hydrochloride oral solution (L-Polamidon® solution for substitution) as reference product
Int J Clin Pharmacol Ther. 2015 Apr;53(4):335-44. doi: 10.5414/CP202180. PMID: 25669614 Clinical Trial
Jain AK, Söderlind E, Viridén A, Schug BS, Abrahamsson B, Knopke C, Tajarobi F, Blume H, Anschütz M, Welinder A, Richardson S, Nagel S, Abrahmsén-Alami S, Weitschies W
The influence of hydroxypropyl methylcellulose (HPMC) molecular weight, concentration and effect of food on in vivo erosion behavior of HPMC matrix tablets
J Control Release. 187: 50-58, 2014
Wedemeyer RS, Blume H
Pharmacokinetic drug interaction profiles of proton pump inhibitors: an update
Drug Saf. 2014 Apr; 37(4):201-11. doi: 10.1007/s40264-014-0144-0. PMID: 24550106 Free PMC article. Review
Jain AK, Viridén A, Welinder A, Schug BS, Abrahmsson B, Knopke C, Söderlind E, Tajarobi F, Blume HH, Anschütz M, Nagel S, Alami Abrahmsén S, Weitschies W
Gastrointestinal erosion behavior of magnetically marked gel matrix tablets
26th AAPS Annual Meeting and Exposition, Chicago, USA, October 14-18, 2012
Schug BS, Donath F, Blume HH
Bioavailability and pharmacodynamics of two 10-mg estradiol valerate depot formulations following i.m. single dose administration in healthy postmenopausal volunteers
Int J Clin Pharmacol Ther. 50 (2): 100-117, 2012
Stauss-Grabo M, Atiye S, Warnke A, Wedemeyer RS, Donath F, Blume HH
Observational study on the tolerability and safety of film-coated tablets containing ivy extract (Prospan® Cough Tablets) in the treatment of colds accompanied by coughing
Phytomedicine. 2011 Apr 15;18(6):433-6. doi: 10.1016/j.phymed.2010.11.009. Epub 2011 Jan 5. PMID: 21211950 Clinical Trial
Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume HH, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX
Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop summary report
Eur J Pharm Sci. 44 (4): 506-513, 2011
Martínez-García C, Medina-Flores Y, De la Rosa-Vázquez JM, Soriano-Pérez EE, Villalobos-Hernández JR, Ramón-Gallegos E
Theranostic-PDT with the antibody anti isoform 4 SOD mitocondrial labeled with PpIX in the lung cancer cell line A-549
Photodiagnosis Photodyn Ther. 2018 Jun;22:197-204. doi: 10.1016/j.pdpdt.2018.03.007. Epub 2018 Mar 27. DOI: 10.1016/j.pdpdt.2018.03.007
Donath F, Braeter M, Feustel C
The influence of propiverine hydrochloride on cardiac repolarization in healthy women and cardiac male patients
Int J Clin Pharmacol Ther. 49 (6): 353-365, 2011
Blume HH, Brendel E, Brudny-Klöppel M, Grebe S, Lausecker B, Rohde G, Siethoff C
Workshop/Conference Report on EMA Draft Guideline on Validation of Bioanalytical Methods
Eur J Pharm Sci. 42 (3): 300-305, 2011
Blume HH, Wedemeyer RS
Austausch von starken Opioiden? – Die therapiäquivalente Arzneimittelqualität muss gewährleistet sein
Dtsch Apoth Ztg. 150 (47): 84-89, 2010
Ruf P, Kluge M, Jäger M, Burges A, Volovat C, Heiss MM, Hess J, Wimberger P, Brandt B, Lindhofer H
Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients
Br J Clin Pharmacol. 69 (6): 617-625, 2010
Sabatowski R, Grond S, Blume HH
Anforderungen an einer optimierte Opioidtherapie chronischer Schmerzen. Gleichmäßige Plasmaspiegel versus chronoadjustierte Analgesie
MMW Fortschr Med. 152: 12-15, 2010
Blume HH, Wedemeyer RS, Gallwitz B
Bedeutung von GLP-1 für die Glucose-Homöostase
Pharm Unserer Zeit. 39 (2): 100-107, 2010
Stauss-Grabo M, Warnke A, Atiye S, Wedemeyer RS, Blume HH
Investigation of the tolerability and safety of film-coated tablets containing ivy extracts (Prospan ® Cough Tablets) in the treatment of colds accompanied by coughing
58th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Products Research, Berlin, 29th August-2nd September, 2010
Anschütz M, Wonnemann M, Schug BS, Toal C, Donath F, Pontius A, Pauli K, Brendel E, Blume HH
Differences in bioavailability between 60mg of nifedipine osmotic pushpull systems after fasted and fed administration
Int J Clin Pharmacol Ther. 48 (2): 158-170, 2010
Blume HH, Schug BS
Bioavailability/bioequivalence requirements of immediate release products: resolutions and issues
In Bioavailability, Bioequivalence and Pharmacokinetic Studies, K. Midha & T. Nagau, eds., Business Centre for Academic Societies Japan, (2010) pp. 101-106
Grape S, Schug SA, Lauer S, Schug BS
Fentanyl Formulations for the Management of Pain: A Review
Drugs. 70 (1): 57-72, 2010
Kuhn UD, Anschütz M, Schmücker K, Schug BS, Hippius M, Blume HH
Phenotyping with sulfasalazine – time dependence and relation to NAT2 pharmacogenetics
Int J Clin Pharmacol Ther. 48 (1): 1-10, 2010
Anschütz M, Garbacz G, Kosch O, Donath F, Wiedmann J, Hoeckh W, Trahms L, Schug BS, Weitschies W, Blume HH
Characterization of the behavior of alginate-based microcapsules in vitro and in vivo
Int J Clin Pharmacol Ther. 47 (9): 556-563, 2009
Garbacz G., Adam U., Schug BS, Blume HH, Weitschies W
Nifedipin-Retardtabletten mit unterschiedlicher Galenik
Dtsch Apoth Ztg. 149 (27): 3010-3016, 2009
Weitschies W, Blume HH, Mönnikes H
Magnetic Marker Monitoring: High resolution real-time tracking of oral solid dosage forms in the gastroinestinal tract
Eur J Pharm Biopharm. 74 (1): 93-101, 2010
Adam U, Schug BS, Blume HH, Weitschies W
Nifedipin-Retardtabletten mit unterschiedlicher Galenik
Dtsch Apoth Ztg. 149 (27): 3010-3016, 2009
Anschütz M, Flochert F, Donath F, Schug BS, Blume HH
Characterisation of gastric residence time of Provide Xtra DRINK in healty volunteers
30th ESPEN Congress, Florence, September 13-16, 2009
Anschütz M, Garbacz G, Kosch O, Donath F, Wiedmann J, Hoeckh W, Trahms L, Schug BS, Weitschies W, Blume HH
Characterization of the behavior of alginate-based microcapsules in vitro and in vivo
Int J Clin Pharmacol Ther. 47 (9): 556-563, 2009
Warnke A, Schug BS, Vanderbist F, Blume HH
Significance of the biopharmaceutical properties of tramadol sustained-release formulations for chrono-pharmacologically optimized treatment of pain from various sources
Int J Clin Pharmacol Ther. 47 (6): 405-412, 2009
Anschütz M, Folchert F, Schug BS, Blume HH, Weitschies W
Characterisation of gastric residence time of ProvideXtra DRINK in healthy volunteers
2008
Blume HH, Ludwig F, Mathis G, Schug BS
GCP-Standards in klinischen Studien mit Medizinprodukten: Chance oder Hindernis?
Medizinprodukte Journal. 15 (3): 148-155, Okt 2008
Kuczka K, Harder S, Picard-Willems B, Warnke A, Donath F, Bianchini P, Parma B, Blume HH
Biomarkers and coagulation tests for assessing the biosimilarity of a generic low-molecular-weight Heparin: Results of a study in healthy subjects with Enoxaparin
J Clin Pharmacol. 48 (10): 1189-1196, 2008
Schug BS, Blume HH
Schneller am Ziel mit Magnetic Marker Monitoring
DZKF. 12 (7-8): 51-56, 2008
Warnke A, Schug BS, Vanderbist F, Blume HH
Importance of the formulation for a chronopharmacologically optimised way of pain therapy. Results of a comparative bioavailability study of tramadol extended-release capsules after single-dose evening versus morning administration
MMW Fortschr Med. 150 (1): 36-42, 2008
Warnke A, Schug BS, Vanderbist F, Blume HH
Bedeutung der Galenik in der »chrono-adjustierten« Schmerzbehandlung.
MMW Fortschr Med. 150 (1): 36-42, 2008
Wonnemann M, Schug BS, Anschütz M, Brendel E, De Nucci G, Blume HH
Comparison of two marketed nifedipine modified-release formulations: An exploratory clinical food interaction study
Clin Ther. 30 (1): 48-58, 2008
Anschütz M, Blume HH, Schug BS, Weitschies W
Gastro-intestinal Transit of Enteric Coated Mesalazine Products: Magnetic Marker Monitoring
CRS 2007 Annual Meeting, Long Beach Convention Center, California, July 7-11, 2007
Nassr N, Lahu G, von Richter O, Reutter F, Knoerzer D, Zech K, Erb KA, Schug BS, Blume HH, Hermann R
Lack of a pharmacokinetic interaction between steady-state roflumilast and single-dose midazolam in healthy subjects
Br J Clin Pharmacol. 2007 Mar;63(3):365-70. Epub 2006 Sep 29 (2007)
Richert H, Kosch O, Görnert P
Magnetic Monitoring as a Diagnostic Method for Investigating Motility in the Human Digestive System
in ´Magnetism in Medicine´, a Handbook, edited by Andrä W and Nowak H, Second Edition, WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim, 2007
Weinmeister S, Donath F, Anschütz M, Folchert F, Schug BS
Gastrointestinal tolerance of a high-energy oral nutritional supplement (ONS) in healthy elderly and dialysis patients
29th ESPEN Congress on Clinical Nutrition and Metabolism, Prague, September 8-11, 2007
Christ T, Wettwer E, Wuest M, Braeter M, Donath F, Champeroux P, Richard S, Ravens U
Electrophysiological profile of propiverine–relationship to cardiac risk
Naunyn Schmiedebergs Arch Pharmacol. 2008 Feb;376(6):431-40. doi: 10.1007/s00210-007-0231-1. Epub 2007 Dec 19. PMID: 18092154
Wonnemann M, Helm I, Stauss-Grabo M, Röttger-Luer P, Tran C-T, Canenbley R, Donath F, Nowak H, Schug BS, Blume HH
Lidocaine 8 mg Sore Throat Lozenges in the Treatment of Acute Pharyngitis
Arzneimittelforschung. 57 (11): 689-697, 2007
Blume HH, Anschütz M, Schmücker K, Schug BS, Haueisen J, Weitschies W
Gastro-intestinal transit of solid oral dosage forms: Imaging studies using Magnetic Marker Monitoring technique
ACCP 2006 Annual Meeting, America´s Center Convention Center, St. Louis, Missouri, October 26–29, 2006
Blume HH, Donath F, Warnke A, Schug BS
Pharmacokinetic Drug Interaction Profiles of Proton Pump Inhibitors
Drug Saf. 29 (9): 769-784, 2006
Haberkorn W, Steinhoff U, Burghoff M, Kosch O, Morguet A, Koch H
Pseudo current density maps of electrophysiological heart, nerve or brain function and their physical basis
Biomagn Res Technol. 4: 5, 2006
Nassr N, Lahu G, von Richter O, Reutter F, Knoerzer D, Zech K, Erb KA, Schug BS, Blume HH, Hermann R
Lack of a pharmacokinetic interaction between steady-state roflumilast and single-dose midazolam in healthy subjects
Br J Clin Pharmacol. 63 (3): 365-370, 2006
Wonnemann M, Schug BS, Schmücker K, Brendel E, van Zwieten PA, Blume HH
Significant food interactions observed with a nifedipine modified-release formulation marketed in the European Union
Int J Clin Pharmacol Ther. 44 (1): 38-48, 2006
Blume HH, Schug BS, Tautz J, Erb KA
Neue Richtlinien für die Beurteilung der Bioverfügbarkeit/ Bioäquivalenz
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 2005 48: 548-555, 2005
Lehmann G, Folchert F, Schug BS, Anschütz M
Charakterisierung der Magenentleerung einer proteinhydrolysathaltigen, kohlenhydratreichen Trinknahrung im Vergleich zu einer kohlenhydratreichen Referenznahrung
Hauptstadtkongress für Anästhesiologie und Intensivmedizin, Berlin 09.06.-11.06.2005
Migliorança LH, Barrientos-Astigarraga RE, Schug BS, Blume HH, Pereira AS, De Nucci G
Felodipine quantification in human plasma by high performance liquid cromatography coupled to tandem mass spectrometry
J Chromatogr B Analyt Technol Biomed Life Sci. 814 (2): 217-223, 2005
Nassr N, Lahu G, Wolf D, Erb KA, Knoerzer D, Zech K, Wurst W, Hermann R
Lack of pharmacokinetic interaction between roflumilast and midazolam
Eur J Clin Pharamcol. 61 (9): 715, 2005
Warnke A, Blume HH
Wie die Arzneiform zum Therapieerfolg beiträgt – Arzneizubereitungen mit Calciumkanal-Blockern
Pharm Unserer Zeit. 34 (5): 400-410, 2005
Wolf D, Folchert F, Blume HH
Gastric emptying and gastric residual volume after intake of a sip feed containing carbohydrates and protein hydrolysate
27th Congress of the European Society of Clinical Nutrition and Metabolism (ESPEN), Brussels 27.08. - 30.08.2005
Keller JH, Karas M, Müller WE, Volmer DA, Eckert GP, Tawab MA, Blume HH, Dingermann T, Schubert-Zsilavecz M
Determination of hyperforin in mouse brain by high-performance liquid chromatography/tandem mass spectrometry
Anal Chem. 75 (22): 6084-6088, 2003
Staab A, Schug BS, Larsimont V, Elze M, Thummler D, Mutschler E, Blume HH
Pharmacokinetics and bioavailability of denaverine hydrochloride in healthy subjects following intravenous, oral and rectal single doses
Eur J Pharm Sci. 18 (2): 121-128, 2003
Blume HH, Wonnemann M, Wolf HT
NSAR: Konzepte zur galenischen Optimierung
Pharm Unserer Zeit. 31 (2): 170-178, 2002
Blume HH, Schug BS, Brendel E
Sind Nifedipin-Retardpräparate austauschbar?
Dtsch Apoth Ztg. 142 (10): 1192-1204, 2002
Kressmann S, Müller WE, Blume HH
Pharmaceutical quality of different Ginkgo biloba brands
J Pharm Pharmacol. 54 (5): 661-669, 2002
Chen X, Zhong D, Xu H, Schug BS, Blume HH
Sensitive and specific liquid chromatographic-tandem mass spectrometric assay for dihydroergotamine and its major metabolite in human plasma
J Chromatogr B Analyt Technol Biomed Life Sci. 768 (2): 267-275, 2002
Kaunzinger A, Baumeister A, Cuda K, Haring N, Schug BS, Blume HH, Raddatz K, Fischer G, Schubert-Zsilavecz M
Determination of 11-keto-boswellic acid in human plasma
J Pharm Biomed Anal. 28 (3-4): 729-739, 2002
Kressmann S, Biber A, Wonnemann M, Schug BS, Blume HH, Müller WE
Influence of pharmaceutical quality on the bioavailability of active components form Ginkgo biloba preparations
J Pharm Pharmacol. 54 (11): 1507-1514, 2002
Meinolf Wonnemann, Ilka Helm, Manuel Stauss-Grabo, Patricia Röttger-Luer, Cam-Tuan Tran, Rainer Canenbley, Frank Donath, Horst Nowak, Barbara S. Schug, Henning H. Blume
Lidocaine 8 mg Sore Throat Lozenges in the Treatment of Acute Pharyngitis
Arzneimittel-Forschung (Drug Research), 2007, 57 (11): 689-697, (2007)
Schug BS, Brendel E, Chantraine E, Wolf D, Martin W, Schall R, Blume HH
The effect of food on the pharmacokinetics of nifedipine in two slow release formulations: pronounced lag-time after a high fat breakfast
Br J Clin Pharmacol. 53 (6): 582-588, 2002
Schug BS, Brendel E, Wolf D, Wonnemann M, Wargenau M, Blume HH
Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union
Eur J Pharm Sci. 15 (9): 279-285, 2002
Schug BS, Brendel E, Wonnemann M, Wolf D, Wargenau M, Dingler A, Blume HH
Dosage form-related food interaction observed in a marketed one-daily nifedipine formulation after a high-fat American breakfast
Eur J Clin Pharmacol. 58 (2): 119-125, 2002
Blume HH, Wonnemann M, Wolf HT
NSAR: Konzepte zur galenischen Optimierung
Pharm Unserer Zeit. 31 (2): 170-178, 2002
Blume HH, Schug BS, Brendel E
Sind Nifedipin-Retardpräparate austauschbar?
Dtsch Apoth Ztg. 142 (10): 1192-1204, 2002
Blume HH, Cordes H, Klaffenbach P, Schug BS
Qualität von Omeprazol-Präparaten
Dtsch Apoth Ztg. 141 (40): 73-78, 2001
Chen X, Zhong D, Xu H, Schug BS, Blume HH
Simultaneous determination of flupirtine and its major active metabolite in human plasma by liquid chromatography-tandem mass spectrometry
J Chromatogr B Biomed Sci Appl. 755 (1-2): 195-202, 2001
Schug BS, Wolf D, Nilius R, Martin W, Schall R, Blume HH
Product related food effects for nifedipine once daily solid oral dosage forms
Poster at the APV-World Conference. Berlin, 2000
Blume HH, Schug BS
Biopharmaceutical characterisation of herbal medicinal products: are in vivo studies necessary?
Eur J Drug Metab Pharmacokinet. 25 (1): 41-48, 2000
Blume HH, Schug BS
Qualität von Eisenpräparaten
Dtsch Apoth Ztg. 139 (7): 47- 50, 1999
Blume HH, Schug BS
The biopharmaceutics classification system (BCS): class III drugs – better candidates for BA/BE waiver?
Eur J Pharm Sci. 9 (2): 117-121, 1999
Breithaupt-Grogler K, Niebch G, Schneider E, Erb K, Hermann R, Blume HH, Schug BS, Belz GG
Dose-proportionality of oral thioctic acid-coincidence of assessments via pooled plasma and individual data
Eur J Pharm Sci. 8 (1): 57-65, 1999
Gleiter CH, Schreeb KH, Freudenthaler S, Thomas M, Elze M, Fieger-Buschges H, Potthast H, Schneider E, Schug BS, Blume HH, Hermann R
Lack of interaction between thioctic acid, glibenclamide and acarbose
Br J Clin Pharmacol. 48 (6): 819-825, 1999
Heinrich-Nols J, Schug BS, Evers G, Larsimont V, Elze M, Blume HH, Lee LS, Crawford F
Bioequivalence study of two morphine extended release formulations after multiple dosing in healthy volunteers
Int J Clin Pharmacol Ther. 37 (3): 153-158, 1999
Mazur D, Schug BS, Evers G, Larsimont V, Fieger-Büschges H, Gimbel W, Keilbach-Bermann A, Blume HH
Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation
Int J Clin Pharmacol Ther. 37 (8): 383-392, 1999
Schug BS, Blume HH
Qualität von Eisenpräparaten – Sind Bioverfügbarkeitsprüfungen erforderlich?
Dtsch Apoth Ztg. 139 (7): 719-722, 1999
Schug BS, Schubert-Zsilavecz M, Blume HH
BCS-Wegweiser bei Phytopharmaka
Loew D, Blume HH, Dingermann T (eds.): Phytopharmaka V, Steinkopff Verlag Darmstadt, 35-42, 1999
Mazur D, Schug BS, Elze M, Blume HH
Klinische Studien 9
Dtsch Apoth Ztg. 138: 3399-3401, 1998
Mazur D, Schug B, Elze M, Blume HH
Klinische Studien 10
138/ (1998) 3658-3661
Mazur D, Schug BS, Evers G, Elze M, Retzow A, Wangemann M, Blume HH
Trough concentrations as parameter for the autoinduction of carbamazepine during repetitive oral administrations
Naunyn Schmiedebergers Arch Pharmacol, 357 (suppl.)/ (1998)
Mazur D, Schug BS, Elze M, Blume HH
Planung, Durchführung und Auswertung klinischer Studien
In Lehrbuch der klinischen Pharmazie, U. Jaehde et al., eds., Wissenschaftliche Verlagsgesellschaft Stuttgart, (1998) pp. 115-137
Schug BS, Hermann R, Blume HH, Elze M
Gender effect on the pharmacokinetics of thioctic acid: an evaluation of several bioavailability studies
Naunyn Schmiedebergers Arch Pharmacol, 357 (suppl.)/ (1998)
Schug BS
Das Biopharmazeutische Klassifizierungssystem BCS – Neuer Ansatz bei der Beurteilung von Arzneimitteln
Dtsch Apoth Ztg. 138 (23): 45-51, 1998
Wangemann M, Retzow A, Evers G, Mazur D, Schug BS, Blume HH
Bioavailability study of two carbamazepine containing sustained release formulations after multiple oral dose administration
Arzneimittelforschung. 48/12 (1998) 1131-1137
Blume HH, Evers G, Elze M, Schug BS, Möhrke W
Absolute Bioavailability of two oral dantrolene formulations
Naunyn Schmiedebergers Arch Pharmacol. 355/ (1997)
Potthast H, Elze M, Fieger-Buschges H, Scheithauer S, Schug BS, Blume HH
Relative bioavailability of etilefrine from different galenical formulations
Naunyn Schmiedebergers Arch Pharmacol. 355/ (1997)
Schug BS, Schneider E, Elze M, Fieger-Buschges H, Larsimont V, Popescu G, Molz K, Blume HH, Hermann R
Study of pharmacokinetic interaction of thioctic acid and metformin
Eur J Clin Pharmacol. 52: 140, 1997
Schug BS, Ruoff J, Schäfer P, Fasold H, Blume HH
Vergleichende Untersuchung von FSH-Produkten
Pharm Ztg. 19: 1570-1575, 1997
Zillig M, Meier J, Scheibe B, Peters F, Schug BS, Blume HH
Zur Qualität von Bluttests in Apotheken
Pharm Ztg. 1666-1671, 1997
Ali S, Blume HH, Schug BS
Sulfonylureas: Physico-chemical properties, analytical methods of determination and bioavailability
In Handbook of Experimental Pharmacology 119, Oral Antidiabetics, J. Kuhlmann & W. Puls, eds., Springer Verlag Berlin, Heidelberg, New York, (1996)
Blume HH, Schug BS
Bioavailability/ Bioeqivalence requirements of immediate release products: resolutions and issues
In Bioavailability, Bioequivalence and Pharmacokinetic Studies, K. Midha & T. Nagai, eds., Business Centre for Academic Societies Japan, (1996) pp. 85-90
Blume HH, Schug BS, Potthast H
Influence of food on the bioavailability of controlled/modified release products, in: Kuhlmann J, Weihrauch TR (eds.).
Eur J Clin Pharmacol. 12: 25-32, 1996
Blume HH, Gundert-Remy U, Schug BS, Elze M, Staab A
Bioverfügbarkeit von Rytmonorm-Importen
Pharm Ztg. 141: 4475-4489, 1996
Schneider E, Gleiter Ch, Schug BS, Elze M, Hermann R, Gundert-Remy U, Blume HH
Influence of food intake on the bioavailability of alpha-lipoic acid.
Eur J Clin Pharmacol. 50 (6): 513-514, 1996
Gleiter CH, Schug BS, Hermann R, Elze M, Blume HH, Gundert-Remy U
Influence of food intake on the bioavailability of thioctic acid enantiomers
Eur J Clin Pharmacol. 50 (6): 513-514, 1996
Larsimont V, Zhong D, Fieger-Buschges H, Schug BS, Staab A, Blume HH
Enantioselective pharmacokinetics and bioavailability of diprafenone in healthy volunteers
Eur J Pharm Sci. 4: 95, 1996
Lipka E, Crison J, Schug BS, Blume HH, Amidon G
Drug interactions in the gastrointestinal tract and their impact on drug absorption and systemic availability: a mechanistic review
In Handbook of experimental pharmacology, Mechanisms of drug interactions, P. D Arcy, J. McElnay, & P. Welling, eds., Springer Verlag Berlin, Heidelberg, New York, (1996) pp. 13-21
Schug BS, Fieger-Buschges H, Elze M, Schneider E, Russ P, Hermann R, Blume HH
Single and multiple dose administration of alpha-lipoic acid in a replicate study design
Eur J Clin Pharmacol. 50: 553, 1996
Schug BS, Elze M, Blume HH
Bioequivalence of highly variable drugs and drug products: steady state studies
In Bioavailability, Bioequivalence and Pharmacokinetic Studies, K. Midha & T. Nagau, eds., Business Centre for Academic Societies Japan, (1996) pp. 101-106
Schug BS, Blume HH
Possibilities and limitations on the interpretation of pharmacokinetic interaction studies (drug-drug, drug-food)
Pharm Unserer Zeit. 25 (4): 195-196, 1996
Blume HH, Elze M, Potthast H, Schug BS
Practical strategies and design advantages in highly variable drug studies: multiple dose and replicate administration design
In Bio-international 2, Bioavailability, Bioequivalence and Pharmacokinetic Studies, H. Blume & K. Midha, eds., medpharm Scientific Publishers Stuttgart, (1995) pp. 117-122
Potthast H, Schug BS, Elze M, Schwerdtle R, Blume HH
Comparison of the bioavailabilities of erythromycin estolate and erythromycin ethylsuccinate dry suspension preparations in steady state
Pharmazie. 50 (1): 56-60, 1995
Potthast H, Schug BS, Blume HH
Vergleich von Erythromycinestolat und Erythromycinethylsuccinat
Sozialpädiatrie und Kinderärztliche Praxis, 17/ (1995) 284-286
Schug BS, Kraemer J, Amels M, Elze M, Fieger-Buschges H, Potthast H, Blume HH
In-vitro und in-vivo-Untersuchungen zu den biopharmazeutischen Eigenschaften zweier Kombinationsanalgetika
In Deutsche Pharmazeutische Gesellschaft.
Schug BS, Kalbhen DA
Influence of chloroquine and other substances on the collagenolytic activity in human osteoarthritic cartilage in vitro
Arzneimittelforschung. 45 (3): 285-289, 1995
Blume HH, Zhong D, Elze M, Wendt G, Schug BS, Scheidel B, Hutt H, Hagenlocher M
Advantages of a steady-state crossover design in assessment of biorquivalence of highly variable drugs: propafenone
Eur J Pharm Sci. 2: 385-393, 1994
Schug BS, Blume HH
Bio International 1994: Wichtige Ergebnisse
Pharm Ztg. 139: 2800-2806, 1994
Schug BS, Kalbhen DA
Human recombinant interleukin-1 alpha and beta and articular tissue integrity. An in vivo study on hens and rats
Arzneimittelforschung. 42 (6): 880-881, 1992
Schug BS, Kalbhen DA
Beeinflussung der Aktivität von Kollagenasen durch verschiedene antirheumatische Wirkstoffe
Pharm Unserer Zeit. 3: 118-119, 1991
