Search Results - "Rudzki, Piotr J"

Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse? by Kaza, Michał, Karaźniewicz-Łada, Marta, Kosicka, Katarzyna, Siemiątkowska, Anna, Rudzki, Piotr J.

“…•New FDA Guidance on bioanalytical method validation is similar to the EMA Guideline.•Differences include suggested validation parameters and terminology.•The…”
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Replicates Number for Drug Stability Testing during Bioanalytical Method Validation-An Experimental and Retrospective Approach by Gniazdowska, Elżbieta, Goch, Wojciech, Giebułtowicz, Joanna, Rudzki, Piotr J

“…The stability of a drug or metabolites in biological matrices is an essential part of bioanalytical method validation, but the justification of its sample size…”
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How does the order of sample analysis influence the matrix effect during LC-MS bioanalysis? by Gniazdowska, Elżbieta, Giebułtowicz, Joanna, Rudzki, Piotr J.

“…[Display omitted] •Sensitivity to matrix effect between interleaved and block schemes was comparable.•Relevant differences were found for particular…”
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Quantitative evaluation of the matrix effect in bioanalytical methods based on LC–MS: A comparison of two approaches by Rudzki, Piotr J., Gniazdowska, Elżbieta, Buś-Kwaśnik, Katarzyna

“…[Display omitted] •Nine analytes of different structure were studied.•Lack of relevant differences between both calculation methods.•CV(%) of IS-norm matrix…”
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10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented? by Kaza, Michał, Sokolovskyi, Alexander, Rudzki, Piotr J.

“…Purpose In 2010 the European Medicines Agency allowed a two-stage design in bioequivalence studies. However, in the public domain there are mainly articles…”
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Matrix effect screening for cloud-point extraction combined with liquid chromatography coupled to mass spectrometry: Bioanalysis of pharmaceuticals by Kojro, Grzegorz, Rudzki, Piotr J., Pisklak, Dariusz M., Giebułtowicz, Joanna

“…•Matrix effect does not limit the use of CPE coupled to LC–MS/MS.•Low surfactant concentration and high extraction temperature reduce the risk of…”
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Visualizing bioanalytical methods – a near or distant future? by Kaza, Michał, Rudzki, Piotr J

“…The latest US FDA guidance (1) and draft ICH M10 guideline (2) promote complementing analytical study reports with a trend graph for the quality control (QC)…”
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Incurred Sample Reanalysis: Time to Change the Sample Size Calculation? by Rudzki, Piotr J., Biecek, Przemysław, Kaza, Michał

“…Reliable results of pharmacokinetic and toxicokinetic studies are vital for correct decision making during drug discovery and development. Thus, ensuring high…”
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Low-oxidation-potential thiophene-carbazole monomers for electro-oxidative molecular imprinting: Selective chemosensing of aripiprazole by Gajda, Marianna, Rybakiewicz, Renata, Cieplak, Maciej, Żołek, Teresa, Maciejewska, Dorota, Gilant, Edyta, Rudzki, Piotr J., Grab, Katarzyna, Kutner, Andrzej, Borowicz, Paweł, Kutner, Wlodzimierz, Noworyta, Krzysztof R.

“…New thiophene-carbazole functional and cross-linking monomers electropolymerizing at potentials sufficiently low for molecular imprinting of an electroactive…”
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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 by Bazydło‐Guzenda, Katarzyna, Jarus‐Dziedzic, Katarzyna, Gierczak‐Pachulska, Agnieszka, Buda, Paweł, Rudzki, Piotr J., Buś‐Kwaśnik, Katarzyna, Juszczyk, Ewelina, Tratkiewicz, Ewa, Rabczenko, Daniel, Segiet‐Święcicka, Agnieszka, Wieczorek, Maciej

“…Aim To assess the safety, tolerability and pharmacokinetic (PK) profile of single and multiple doses of CPL207280, a new G‐protein‐coupled receptor 40 agonist…”
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Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100mg dose administration by Filist, Monika, Buś-Kwaśnik, Katarzyna, Ksycińska, Hanna, Rudzki, Piotr J.

“…•Azithromycin determination in human plasma in range of 0.5–250.0ng/mL.•First report of descladinose azithromycin back-conversion to the parent drug.•Over 5000…”
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Is a deuterated internal standard appropriate for the reliable determination of olmesartan in human plasma? by Piórkowska, Edyta, Musijowski, Jacek, Buś-Kwaśnik, Katarzyna, Rudzki, Piotr J.

“…•First method using deuterated internal standard to quantify olmesartan in plasma.•First report on stability of olmesartan-d6 in methanol and 50% methanol…”
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Determination of sunitinib in human plasma using liquid chromatography coupled with mass spectrometry by Musijowski, Jacek, Piórkowska, Edyta, Rudzki, Piotr J

“…An original method based on liquid chromatography with single quadrupole electrospray ionization mass spectrometry was developed for the determination of…”
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Cloud-point extraction is compatible with liquid chromatography coupled to electrospray ionization mass spectrometry for the determination of bisoprolol in human plasma by Giebułtowicz, Joanna, Kojro, Grzegorz, Buś-Kwaśnik, Katarzyna, Rudzki, Piotr J., Marszałek, Ryszard, Leś, Andrzej, Wroczyński, Piotr

“…•Simple, environment-friendly sample preparation by cloud-point extraction (CPE).•First report on compatibility of CPE and LC–ESI–MS/MS.•First application of…”
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Simplified LC–MS/MS method enabling the determination of azithromycin in human plasma after a low 100 mg dose administration by Filist, Monika, Buś-Kwaśnik, Katarzyna, Ksycińska, Hanna, Rudzki, Piotr J.

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Bioequivalence of Rivaroxaban Hard Capsules vs. Film-Coated Tablets in Healthy White Volunteers by Gierczak-Pachulska, Agnieszka, Kaza, Michał, Jarus-Dziedzic, Katarzyna, Czerepow-Bielik, Olga, Segiet-Święcicka, Agnieszka, Huszcza, Grzegorz, Sidoruk, Katarzyna, Rabczenko, Daniel, Rudzki, Piotr J.

“…Rivaroxaban is an oral anticoagulant that is a selective, direct factor Xa inhibitor. It is used to prevent thrombotic events of atherosclerotic etiology and…”
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Comprehensive graphical presentation of data from incurred sample reanalysis by Rudzki, Piotr J, Biecek, Przemys aw, Kaza, Micha

“…Incurred sample reanalysis (ISR) contributes to the reliability of pharmacokinetic studies. Despite regulatory guidelines having adopted ISR methodology,…”
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Sensitive single quadrupole LC/MS method for determination of lapatinib in human plasma by Musijowski, Jacek, Filist, Monika, Rudzki, Piotr J

“…A sensitive liquid chromatographic-single quadrupole mass spectrometric method was developed and validated for the determination of lapatinib in human plasma…”
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Extended 3D and 4D cumulative plots for evaluation of unmatched incurred sample reanalysis by Rudzki, Piotr J, Kaza, Micha, Biecek, Przemys aw

“…Incurred sample reanalysis (ISR) helps ensure the reliability of pharmacokinetic studies. An appropriate graph may facilitate the evaluation of an unmatched…”
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HPLC-UV ASSAY OF IMATINIB IN HUMAN PLASMA OPTIMIZED FOR BIOEQUIVALENCE STUDIES by Kaza, Michal, Piorkowska, Edyta, Filist, Monika, Rudzki, Piotr J

“…lmatimb is an anticancer drug approved for the treatment of a number of cancers, mostly used in chronic myeloid leukemia. Numerous bioanalytical methods using…”
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