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Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

Journal of pharmaceutical and biomedical analysis, 2019-02, Vol.165, p.381-385

2019

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Replicates Number for Drug Stability Testing during Bioanalytical Method Validation-An Experimental and Retrospective Approach

Molecules (Basel, Switzerland), 2022-01, Vol.27 (2), p.457

2022

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Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet

Journal of bone and joint surgery. American volume, 2004-01, Vol.86 (1), p.22-27

2004

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Early autologous and/or allogeneic stem cell transplantation for adult patients with advanced stage T- lymphoblastic leukemia/lymphoma or Burkitt lymphoma. A retrospective single-centre analysis

Annals of hematology, 2024-11, Vol.103 (11), p.4701-4705

2024

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Autologous stem cell transplantation following simultaneous liver and kidney transplantation in severe amyloid light chain amyloidosis associated with multiple myeloma: a case report

Journal of medical case reports, 2020-10, Vol.14 (1), p.201-201, Article 201

2020

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How does the order of sample analysis influence the matrix effect during LC-MS bioanalysis?

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2023-07, Vol.1227, p.123800-123800, Article 123800

2023

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Quantitative evaluation of the matrix effect in bioanalytical methods based on LC–MS: A comparison of two approaches

Journal of pharmaceutical and biomedical analysis, 2018-06, Vol.155, p.314-319

2018

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Early autologous and allogeneic peripheral blood stem cell transplantation for adult patients with acute B and T cell precursor neoplasms: a 12-year single center experience

Annals of hematology, 2021-03, Vol.100 (3), p.809-816

2021

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Cassini Plasma Spectrometer Investigation

Space science reviews, 2004-09, Vol.114 (1-4), p.1-112

2004

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Rapid and simplified HPLC-UV method with on-line wavelengths switching for determination of capecitabine in human plasma

Pharmazie, 2014-07, Vol.69 (7), p.500-505

2014

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10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?

Pharmaceutical research, 2020-07, Vol.37 (7), p.140, Article 140

2020

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Matrix effect screening for cloud-point extraction combined with liquid chromatography coupled to mass spectrometry: Bioanalysis of pharmaceuticals

Journal of Chromatography A, 2019-04, Vol.1591, p.44-54

2019

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Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100 mg dose administration

Journal of pharmaceutical and biomedical analysis, 2014-11, Vol.100, p.184-189

2014

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Efficacy of Field Treatments to Reduce Body Core Temperature in Hyperthermic Subjects

Medicine and science in sports and exercise, 2009-11, Vol.41 (11), p.1984-1990

2009

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Visualizing bioanalytical methods – a near or distant future?

Bioanalysis, 2020-04, Vol.12 (7), p.427-429

2020

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Bioequivalence of Rivaroxaban Hard Capsules vs. Film-Coated Tablets in Healthy White Volunteers

Acta Poloniae pharmaceutica, 2024-04, Vol.81 (1), p.97-108

2024

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Incurred Sample Reanalysis: Time to Change the Sample Size Calculation?

The AAPS journal, 2019-02, Vol.21 (2), p.28, Article 28

2019

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Low-oxidation-potential thiophene-carbazole monomers for electro-oxidative molecular imprinting: Selective chemosensing of aripiprazole

Biosensors & bioelectronics, 2020-12, Vol.169, p.112589, Article 112589

2020

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Current treatment concepts of Philadelphia-negative MPN

Current cancer drug targets, 2011-01, Vol.11 (1), p.44-55

2011

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New Approaches to Diagnosis and Arthroscopic Management of Partial-Thickness Cuff Tears

Clinics in sports medicine, 2008-10, Vol.27 (4), p.691-717

2008

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Resolution Of Neuropsychiatric Symptoms Of Post-Concussion Syndrome With An Acetylcholinesterase Inhibitor: 2040

Medicine and science in sports and exercise, 2024-10, Vol.56 (10S), p.713-713

Rudzki, Stephan J.

2024

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Heart Rate Variability As A Biomarker For The Management Of Post-Concussion Syndrome (PCS): 1412

Medicine and science in sports and exercise, 2023-09, Vol.55 (9S), p.474-474

Rudzki, Stephan J.

2023

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First‐in‐human study of CPL207280, a novel G‐protein‐coupled receptor 40/free fatty acid receptor 1 agonist, in healthy volunteers after single and multiple administration

Diabetes, obesity & metabolism, 2024-04, Vol.26 (4), p.1376-1385

2024

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Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100mg dose administration

Journal of pharmaceutical and biomedical analysis, 2014-11, Vol.100, p.184-189

2014

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Is a deuterated internal standard appropriate for the reliable determination of olmesartan in human plasma?

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2017-01, Vol.1040, p.53-59

2017

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Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

Replicates Number for Drug Stability Testing during Bioanalytical Method Validation-An Experimental and Retrospective Approach

Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet

Early autologous and/or allogeneic stem cell transplantation for adult patients with advanced stage T- lymphoblastic leukemia/lymphoma or Burkitt lymphoma. A retrospective single-centre analysis

Autologous stem cell transplantation following simultaneous liver and kidney transplantation in severe amyloid light chain amyloidosis associated with multiple myeloma: a case report

How does the order of sample analysis influence the matrix effect during LC-MS bioanalysis?

Quantitative evaluation of the matrix effect in bioanalytical methods based on LC–MS: A comparison of two approaches

Early autologous and allogeneic peripheral blood stem cell transplantation for adult patients with acute B and T cell precursor neoplasms: a 12-year single center experience

Cassini Plasma Spectrometer Investigation

Rapid and simplified HPLC-UV method with on-line wavelengths switching for determination of capecitabine in human plasma

10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?

Matrix effect screening for cloud-point extraction combined with liquid chromatography coupled to mass spectrometry: Bioanalysis of pharmaceuticals

Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100 mg dose administration

Efficacy of Field Treatments to Reduce Body Core Temperature in Hyperthermic Subjects

Visualizing bioanalytical methods – a near or distant future?

Bioequivalence of Rivaroxaban Hard Capsules vs. Film-Coated Tablets in Healthy White Volunteers

Incurred Sample Reanalysis: Time to Change the Sample Size Calculation?

Low-oxidation-potential thiophene-carbazole monomers for electro-oxidative molecular imprinting: Selective chemosensing of aripiprazole

Current treatment concepts of Philadelphia-negative MPN

New Approaches to Diagnosis and Arthroscopic Management of Partial-Thickness Cuff Tears

Resolution Of Neuropsychiatric Symptoms Of Post-Concussion Syndrome With An Acetylcholinesterase Inhibitor: 2040

Heart Rate Variability As A Biomarker For The Management Of Post-Concussion Syndrome (PCS): 1412

First‐in‐human study of CPL207280, a novel G‐protein‐coupled receptor 40/free fatty acid receptor 1 agonist, in healthy volunteers after single and multiple administration

Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100mg dose administration

Is a deuterated internal standard appropriate for the reliable determination of olmesartan in human plasma?

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