H. Blume

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Predicting the oral pharmacokinetic profiles of multiple-unit (pellet) dosage forms using a modeling and simulation approach coupled with biorelevant dissolution testing: case example diclofenac sodium.

Atsushi Kambayashi, Jennifer B Dressman, J. Dressman, 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Drug Interactions in the Gastrointestinal Tract and Their Impact on Drug Absorption and Systemic Availability: A Mechanistic Review

J. Crison, G. Amidon, B. Schug, 1996 .

Pharmaceutical Quality of Glibenclamide Products A Multinational Postmarket Comparative Study

H. Blume, M. Siewert, S. L. Ali, 1993 .

Bioequivalence studies: single vs multiple dose.

V. Steinijans, H. Blume, J. Jonkman, 1989, International journal of clinical pharmacology, therapy, and toxicology.

Dose-proportionality of oral thioctic acid--coincidence of assessments via pooled plasma and individual data.

R. Hermann, K. Erb, K. Breithaupt-Grögler, 1999, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Determination of hyperforin in mouse brain by high-performance liquid chromatography/tandem mass spectrometry.

M. Schubert-Zsilavecz, T. Dingermann, M. Karas, 2003, Analytical Chemistry.

Sulfonylureas: Physico-chemical Properties, Analytical Methods of Determination and Bioavailability

B. Schug, H. Blume, S. L. Ali, 1996 .

Bioavailability Study of Two Different Verapamil Formulations

E. Mutschler, H. Knauf, H. Blume, 1992, Archiv der Pharmazie.

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.

F. Donath, H. Blume, M. Stauss-Grabo, 2011, Phytomedicine : international journal of phytotherapy and phytopharmacology.

Lack of a pharmacokinetic interaction between steady-state roflumilast and single-dose midazolam in healthy subjects

R. Hermann, K. Erb, B. Schug, 2007 .

Clinical chronopharmacology of oral sustained-release isosorbide-5-mononitrate in healthy subjects

B. Lemmer, B. Scheidel, H. Blume, 2004, European Journal of Clinical Pharmacology.

Pharmaceutical quality of different Ginkgo biloba brands

H. Blume, S. Kressmann, W. Müller, 2002, The Journal of pharmacy and pharmacology.

Enantioselective pharmacokinetics and bioavailability of different racemic α-lipoic acid formulations in healthy volunteers

R. Hermann, P. Ruus, G. Niebch, 1996 .

Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration.

E. Brendel, B. Schug, F. Donath, 2010, International journal of clinical pharmacology and therapeutics.

The Two Main Goals of Bioequivalence Studies

L. Endrenyi, L. Tothfalusi, H. Blume, 2017, The AAPS Journal.

Stereoselective pharmacokinetics of propafenone and its major metabolites in healthy Chinese volunteers.

D. Zhong, H. Blume, X. Chen, 2000, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Bio-International ’94 Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studiesand Pre-Conference Satellite on ‘in vivo/in vitro correlation’

K. Midha, I. McGilveray, H. Blume, 1995, European Journal of Drug Metabolism and Pharmacokinetics.

Determination of isosorbide dinitrate and its two mononitrate metabolites in human plasma and saliva through gas-liquid chromatography with electron-capture detection

H. Blume, Syed Laik Ali, 1985 .

Influence of food intake on the bioavailability of thioctic acid enantiomers

U. Gundert-Remy, C. Gleiter, R. Hermann, 1996, European Journal of Clinical Pharmacology.

Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation.

B. Schug, H. Blume, D. Mazur, 1999, International journal of clinical pharmacology and therapeutics.

The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?

B. Schug, H. Blume, H H Blume, 1999, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[HPLC-determination of loratadine and its active metabolite descarboethoxyloratadine in human plasma].

H. Blume, D. Zhong, 1994, Die Pharmazie.

Pharmacodynamic Profile of Verapamil in Relation to Absolute Bioavailability: Investigations with a Conventional and a Controlled‐Release Formulation

P. Thürmann, S. Harder, H. Blume, 1991, Journal of cardiovascular pharmacology.

Sensitive and specific liquid chromatographic-tandem mass spectrometric assay for dihydroergotamine and its major metabolite in human plasma.

Xiaoyan Chen, D. Zhong, B. Schug, 2002, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Influence of pharmaceutical quality on the bioavailability of active components from Ginkgo biloba preparations

B. Schug, H. Blume, S. Kressmann, 2002, The Journal of pharmacy and pharmacology.

E. Brendel, M. Wargenau, B. Schug, 2002, European Journal of Clinical Pharmacology.

[The relative bioavailability of paracetamol in suppositories in comparison to tablets].

J. Krämer, H. Blume, M. Elze, 1996, Arzneimittel-Forschung.

Biopharmaceutical aspects of multiparticulates

J. Krämer, H. Blume, 1994 .

Understanding the in vivo performance of enteric coated tablets using an in vitro-in silico-in vivo approach: case example diclofenac.

Atsushi Kambayashi, Jennifer Dressman, J. Dressman, 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Bio-International ’92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies

K. Midha, H. Blume, 1993 .

Bio-International 92, Conference on Bioavailability, Bioequivalence, and Pharmacokinetic Studies

K. Midha, H. Blume, 1993 .

Bioequivalence

H. Blume, 2018, Drug Discovery and Evaluation: Methods in Clinical Pharmacology.

Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products.

Malcolm Rowland, Rodrigo Cristofoletti, Amin Rostami-Hodjegan, 2018, Journal of pharmaceutical sciences.

Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

V. Shah, I. Antal, S. Stegemann, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Workshop/conference report on EMA draft guideline on validation of bioanalytical methods.

Margarete Brudny-Klöppel, Berthold Lausecker, Henning Blume, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Absorption of Isosorbide Dinitrate after Administration as Spray, Ointment and Microemulsion Patch. An In‐vitro Study Using the Isolated Perfused Bovine Udder

W. Löscher, B. Müller, H. Blume, 1995 .

Pharmacokinetics and bioavailability of denaverine hydrochloride in healthy subjects following intravenous, oral and rectal single doses.

A. Staab, B. Schug, E. Mutschler, 2003, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

The effect of food on the pharmacokinetics of nifedipine in two slow release formulations: pronounced lag-time after a high fat breakfast.

R. Schall, E. Brendel, B. Schug, 2002, British journal of clinical pharmacology.

Gas-liquid chromatography-mass spectroscopy determination of clopamide in plasma.

F. Sörgel, W. Stüber, H. Blume, 1989, Journal of pharmaceutical sciences.

Biomarkers and Coagulation Tests for Assessing the Biosimilarity of a Generic Low‐Molecular‐Weight Heparin: Results of a Study in Healthy Subjects With Enoxaparin

Sebastian Harder, Bettina Picard-Willems, F. Donath, 2008, Journal of clinical pharmacology.

Grapefruit juice increases oral nimodipine bioavailability.

U. Fuhr, A. Staib, M. Zaigler, 1998, International journal of clinical pharmacology and therapeutics.

Reference tables for the intrasubject coefficient of variation in bioequivalence studies.

D Hauschke, R. Schall, D. Hauschke, 1995, International journal of clinical pharmacology and therapeutics.

Felodipine quantification in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry.

G. De Nucci, B. Schug, A. Pereira, 2005, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Validated high-performance liquid chromatographic assay for the determination of promazine in human plasma: Application to pharmacokinetic studies

H. Blume, H. Fieger-Büschges, V. Larsimont, 1998 .

Simultaneous determination of flupirtine and its major active metabolite in human plasma by liquid chromatography-tandem mass spectrometry.

B. Schug, H. Blume, X. Chen, 2001, Journal of chromatography. B, Biomedical sciences and applications.

Determination of clindamycin in human plasma by high-performance liquid chromatography using coupled columns.

H. Blume, H. Fieger-Büschges, V. Larsimont, 1999, Journal of chromatography. B, Biomedical sciences and applications.

Advantages of a steady-state crossover design in assessment of bioequivalence of highly variable drugs : propafenone

D. Zhong, B. Schug, B. Scheidel, 1994 .

Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence

Donald J. Schuirmann, L. Endrenyi, J. Welink, 2019, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Clinical chronopharmacology of oral nitrates.

B. Lemmer, B. Scheidel, H. Blume, 1989, Zeitschrift fur Kardiologie.

flP Guidelines for Dissolution Testing of Solid Oral Products Joint Report of the Section for O"icial laboratories and Medicines Control Services and the Section of Industrial Pharmacists of the FIP

L. Lesko, V. Shah, J. Dressman, 1997 .

P166 determination of the bioavailability of tranylcypromine with a stereospecific assay

H. Spahn‐Langguth, E. Mutschler, H. Potthast, 1994 .

The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.

W. Weitschies, J. Welink, Mei-ling Chen, 2018, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

When Are Bioavailability Studies Required? A German Proposal

U. Klotz, C. Gleiter, S. Harder, 1998, Journal of clinical pharmacology.

Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union.

E. Brendel, M. Wargenau, B. Schug, 2002, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Comparison of two marketed nifedipine modified-release formulations: an exploratory clinical food interaction study.

E. Brendel, G. De Nucci, B. Schug, 2008, Clinical Therapeutics.

Significant food interactions observed with a nifedipine modified-release formulation marketed in the European Union.

E. Brendel, P. V. van Zwieten, B. Schug, 2006, International journal of clinical pharmacology and therapeutics.

Plasma concentrations of S-verapamil after single doses of two different galenic formulations of racemic verapamil.

P. Thürmann, S. Harder, H. Blume, 1993, Arzneimittel-Forschung.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Lawrence X. Yu, V. Shah, J. Dressman, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Lack of interaction between thioctic acid, glibenclamide and acarbose.

C. Gleiter, R. Hermann, K. Schreeb, 1999, British journal of clinical pharmacology.

Lidocaine 8 mg Sore Throat Lozenges in the Treatment of Acute Pharyngitis

B. Schug, F. Donath, H. Blume, 2007, Arzneimittelforschung.

Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

Lawrence X. Yu, J. Dressman, T. Hyslop, 2011, The AAPS Journal.

Bioavailability study of two carbamazepine containing sustained release formulations after multiple oral dose administration.

B. Schug, H. Blume, D. Mazur, 1998, Arzneimittel-Forschung.

Pharmacokinetics and pharmacodynamics of the acetylcholinesterase inhibitor metrifonate in patients with renal impairment.

R. Heinig, A. Halabi, J. Dingemanse, 1999, Therapeutic drug monitoring.

Phenotyping with sulfasalazine - time dependence and relation to NAT2 pharmacogenetics.

M. Hippius, B. Schug, H. Blume, 2010, International journal of clinical pharmacology and therapeutics.

Determination of 11-keto-boswellic acid in human plasma.

M. Schubert-Zsilavecz, G. Fischer, B. Schug, 2002, Journal of Pharmaceutical and Biomedical Analysis.

Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies.

H. Blume, M. Elze, E. Diletti, 1994, International journal of clinical pharmacology and therapeutics.

J. Dressman, A. Kambayashi, H. Blume, 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Enantioselective determination of diprafenone in human plasma.

H. Blume, D. Zhong, R. Chen, 1997, Die Pharmazie.

Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

V. Shah, I. Antal, S. Stegemann, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.