Search Results - "Kaza, Michal"

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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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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LC-MS/MS determination of dutasteride and its major metabolites in human plasma by Gniazdowska, Elżbieta, Kaza, Michał, Buś-Kwaśnik, Katarzyna, Giebułtowicz, Joanna

“…Dutasteride is a specific and selective inhibitor of both 5α-reductase isoforms used mainly in benign prostatic hyperplasia and lower urinary tract symptoms…”
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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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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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Validated HPLC-UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol by Filist, Monika, Szlaska, Iwona, Kaza, Michał, Pawiński, Tomasz

“…Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during…”
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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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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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Determination of duloxetine in human plasma with proven lack of influence of the major metabolite 4-hydroxyduloxetine by Kaza, Michał, Gilant, Edyta, Filist, Monika, Szlaska, Iwona, Pawiński, Tomasz, Rudzki, Piotr J.

“…Minimizing the impact of major or unstable metabolites on the determination of a drug substance represents a leading task in the development and validation of…”
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Incurred sample reanalysis: adjusted procedure for sample size calculation by Rudzki, Piotr J, Bu -Kwa nik, Katarzyna, Kaza, Micha

“…The incurred sample reanalysis (ISR) helps to assure bioanalysis reliability. The regulatory guidelines recommend the reanalysis of up to 10% of the study…”
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Validated HPLC method for determination of temozolomide in human plasma by Gilant, Edyta, Kaza, Michał, Szlagowska, Anna, Serafin-Byczak, Krystyna, Rudzki, Piotr J

“…The aim of the study was to develop a bioanalytical method for the determination of temozolomide (TMZ) in human plasma. Plasma concentration of TMZ was…”
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Validated HPLC method for determination of cefuroxime in human plasma by Szlagowska, Anna, Kaza, Michał, Rudzki, Piotr J

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Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers by Kaza, Michał, Leś, Andrzej, Serafin-Byczak, Krystyna, Ksycińska, Hanna, Rudzki, Piotr J, Gutkowskpi, Piotr, Drewniak, Tomasz, Gutkowska, Anna, Tarasiuk, Andrzej, Piatkowska-Chabuda, Ewa, Skowrońska-Smolak, Małgorzata, Wilkowska, Ewa

“…The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of…”
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