The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and appropriate acceptance criteria for these assays. Both qPCR and dPCR are extensively used to answer bioanalytical questions for novel modalities such as cell and gene therapies. Following cross-industry conversations on the lack of information and guidelines for these assays, an American Association of Pharmaceutical Scientists working group was formed to address these gaps by bringing together 37 industry experts from 24 organizations to discuss best practices to gain a better understanding in the industry and facilitate filings to health authorities. Herein, this team provides considerations on assay design, development, and validation testing for PCR assays that are used in cell and gene therapies including (1) biodistribution; (2) transgene expression; (3) viral shedding; (4) and persistence or cellular kinetics of cell therapies.

• Klíčová slova
• AAV, RT-qPCR, biodistribution, cell therapy, cellular kinetics, dPCR, gene therapy, qPCR, shedding, transgene expression,
• MeSH
• genetická terapie * MeSH
• polymerázová řetězová reakce MeSH
• tkáňová distribuce MeSH
• vyvíjení léků * MeSH
• Publikační typ
• časopisecké články MeSH

The global situation related to the COVID-19 pandemic has forced employers to find an adequate way to conduct training in order to ensure work safety. The underground mining industry is one of the industries which, due to its nature, was not able to switch to remote work. Conducting traditional training risked spreading the virus among workers. For this purpose, it was necessary to start a search for a form of training that would be safe and would not cause additional stress for employees. Research on the development of an active employee training method and testing of the method itself was conducted online. In order to develop a method of active training, one of the most important workstations was selected, which is the operation of the conveyor belt. The training method comprises four training modules. The modules cover questions related to the operation of the conveyor belt, emergencies, its assembly and disassembly, repair and maintenance. The developed issues also take into account questions concerning natural hazards and work safety. The entire training course lasts 10 days. Every day, an employee receives a set of eight questions sent to their email address, which they must answer before starting work. The article describes the methodology and implementation of the training.

• Klíčová slova
• active training method, human factor, occupational stress, underground mining, work safety,
• MeSH
• COVID-19 * MeSH
• lidé MeSH
• pandemie * MeSH
• SARS-CoV-2 MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

• MeSH
• kognice * MeSH
• lidé MeSH
• operantní podmiňování * MeSH
• předškolní dítě MeSH
• vývoj dítěte * MeSH
• Check Tag
• lidé MeSH
• předškolní dítě MeSH
• Publikační typ
• časopisecké články MeSH

• MeSH
• elektronová mikroskopie MeSH
• embryonální a fetální vývoj MeSH
• kůže embryologie   MeSH
• lidé MeSH
• metody MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

• Klíčová slova
• GROWTH *,
• MeSH
• dítě MeSH
• lidé MeSH
• růst * MeSH
• vývoj dítěte * MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

Cotton-titania nanocomposites with multifunctional properties were synthesized through ultrasonic acoustic method (UAM). Ultrasonic irradiations were used as a potential tool to develop cotton-titania (CT) nanocomposites at low temperature in the presence of titanium tetrachloride and isopropanol. The synthesized samples were characterized by XRD, SEM, EDX and ICP-OES methods. Functional properties i.e. Ultraviolet protection factor (UPF), self-cleaning, washing durability, antimicrobial and tensile strength of the CT nanocomposites were evaluated by different methods. Central composite design and response surface methodology were employed to evaluate the effects of selected variables on responses. The results confirm the simultaneous formation and incorporation of anatase TiO2 with average crystallite size of 4nm on cotton fabric with excellent photocatalytic properties. The sustained self-cleaning efficiency of CT nanocomposites even after 30 home launderings indicates their excellent washing durability. Significant effects were obtained during statistical analysis for selected variables on the formation and incorporation of TiO2 nanoparticles (NPs) on cotton and photocatalytic properties of the CT nanocomposites.

• Klíčová slova
• Nanocomposites, Self-cleaning, TiO(2), UPF, Ultrasonic acoustic method (UAM),
• Publikační typ
• časopisecké články MeSH

The aim of this study was to develop benzydamine hydrochloride-loaded orodispersible films using the modification of a solvent casting method. An innovative approach was developed when the drying process of a small-scale production was used based on a heated inert base for casting the film. During this process, two types of film-forming maltodextrins for rapid drug delivery were used. They were plasticized with two different polyols (xylitol and sorbitol). Superdisintegrant Kollidon® CL-F was tested as an excipient that can induce faster disintegration of the prepared films. The influence of the formulation parameters (dextrose equivalent of film-forming maltodextrins, a type of plasticizer, and the presence of superdisintegrant) on the disintegration time, mechanical properties, and moisture content of films was statistically evaluated using a multivariate data analysis. Orodispersible films containing maltodextrin with lower dextrose equivalent value showed better mechanical properties (tensile strength ranged from 886.6 ± 30.2 to 1484.2 ± 226.9 N cm-2), lower moisture content (0.5 ± 0.0 to 1.2 ± 0.2%), and shorter disintegration time (17.6 ± 2.9 to 27.8 ± 2.8 s). Films plasticized with xylitol showed shorter disintegration time (17.6 ± 2.9 to 29.2 ± 3.8 s) than films containing sorbitol (23.8 ± 2.9 to 31.7 ± 3.9 s). With the addition of superdisintegrant Kollidon® CL-F, a significant influence on disintegration time was not observed. The modified solvent casting method shows great promise in a small-scale laboratory production of orodispersible films, e.g., in a pharmacy lab.

• Klíčová slova
• benzydamine hydrochloride, maltodextrins, multivariate data analysis, orodispersible films, solvent casting method,
• MeSH
• benzydamin chemie   MeSH
• lékové transportní systémy * MeSH
• polysacharidy chemie   MeSH
• povidon chemie   MeSH
• rozpouštědla chemie   MeSH
• změkčovadla chemie   MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• benzydamin MeSH
• maltodextrin MeSH Prohlížeč
• polysacharidy MeSH
• povidon MeSH
• rozpouštědla MeSH
• změkčovadla MeSH

OBJECTIVES: Clinical practice guidelines (CPGs) are often created through collaboration among organizations. The use of inconsistent terminology may cause poor communication and delays. This study aimed to develop a glossary of terms related to collaboration in guideline development. STUDY DESIGN AND SETTING: A literature review of collaborative guidelines was performed to develop an initial list of terms related to guideline collaboration. The list of terms was presented to the members of the Guideline International Network Guidelines Collaboration Working Group, who provided presumptive definitions for each term and proposed additional terms to be included. The revised list was subsequently reviewed by an international, multidisciplinary panel of expert stakeholders. Recommendations received during this pre-Delphi review were implemented to augment an initial draft glossary. The glossary was then critically evaluated and refined through two rounds of Delphi surveys and a virtual consensus meeting with all panel members as Delphi participants. RESULTS: Forty-nine experts participated in the pre-Delphi survey, and 44 participated in the two-round Delphi process. Consensus was reached for 37 terms and definitions. CONCLUSION: Uptake and utilization of this guideline collaboration glossary by key organizations and stakeholder groups may facilitate collaboration among guideline-producing organizations by improving communication, minimizing conflicts, and increasing guideline development efficiency.

• Klíčová slova
• Clinical, Collaboration, Delphi, Development, Glossary, Guideline, International, Practice, Validation,
• MeSH
• delfská metoda MeSH
• komunikace * MeSH
• konsensus MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

A capillary electrophoresis method for the simultaneous determination of the enantiomeric purity and of impurities of the chiral calcimimetic drug cinacalcet hydrochloride has been developed following Quality by Design principles. The scouting phase was aimed to select the separation operative mode and to identify a suitable chiral selector. Among the tested cyclodextrins, (2-carboxyethyl)-β-cyclodextrin and (2-hydroxypropyl)-γ-cyclodextrin (HPγCyD) showed good chiral resolving capabilities. The selected separation system was solvent-modified capillary zone electrophoresis with the addition of HPγCyD and methanol. Voltage, buffer pH, methanol concentration and HPγCyD concentration were investigated as critical method parameters by a multivariate strategy. Critical method attributes were represented by enantioresolution and analysis time. A Box-Behnken Design allowed the contour plots to be drawn and quadratic and interaction effects to be highlighted. The Method Operable Design Region (MODR) was identified by applying Monte-Carlo simulations and corresponded to the multidimensional zone where both the critical method attributes fulfilled the requirements with a desired probability π≥90%. The working conditions, with the MODR limits, corresponded to the following: capillary length, 48.5cm; temperature, 18°C; voltage, 26kV (26-27kV); background electrolyte, 150mM phosphate buffer pH 2.70 (2.60-2.80), 3.1mM (3.0-3.5mM) HPγCyD; 2.00% (0.00-8.40%) v/v methanol. Robustness testing was carried out by a Plackett-Burman matrix and finally a method control strategy was defined. The complete separation of the analytes was obtained in about 10min. The method was validated following the International Council for Harmonisation guidelines and was applied for the analysis of a real sample of cinacalcet hydrochloride tablets.

• Klíčová slova
• Capillary electrophoresis, Chiral separation, Cinacalcet, Impurities, Method operable design region, Quality by Design,
• MeSH
• beta-cyklodextriny chemie   MeSH
• cinakalcet chemie   izolace a purifikace   MeSH
• elektroforéza kapilární metody   MeSH
• gama-cyklodextriny chemie   MeSH
• hodnocení rizik MeSH
• koncentrace vodíkových iontů MeSH
• kontaminace léku MeSH
• metoda Monte Carlo MeSH
• pravděpodobnost MeSH
• rozpouštědla MeSH
• stereoizomerie MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• beta-cyklodextriny MeSH
• betadex MeSH Prohlížeč
• cinakalcet MeSH
• gama-cyklodextriny MeSH
• gamma-cyclodextrin MeSH Prohlížeč
• rozpouštědla MeSH

The aim of this study was to develop a simple extraction procedure and a multiresidual liquid chromatography-tandem mass spectrometry method for determination of a wide range of pharmaceuticals from various soil types. An extraction procedure for 91 pharmaceuticals from 13 soil types, followed by liquid chromatography-tandem mass spectrometry analysis, was optimized. The extraction efficiencies of three solvent mixtures for ultrasonic extraction were evaluated for 91 pharmaceuticals. The best results were obtained using acetonitrile/water (1/1 v/v with 0.1 % formic acid) followed by acetonitrile/2-propanol/water (3/3/4 v/v/v with 0.1 % formic acid) for extracting 63 pharmaceuticals. The method was validated at three fortification levels (10, 100, and 1000 ng/g) in all types of representative soils; recovery of 44 pharmaceuticals ranged between 55 and 135 % across all tested soils. The method was applied to analyze actual environmental samples of sediments, soils, and sludge, and 24 pharmaceuticals were found above limit of quantification with concentrations ranging between 0.83 ng/g (fexofenadine) and 223 ng/g (citalopram).

• Klíčová slova
• Extraction efficiency, Extraction method, Liquid chromatography-tandem mass spectrometry, Matrix effects, Sediments, Sludge, Validation,
• MeSH
• 2-propanol MeSH
• acetonitrily MeSH
• chromatografie kapalinová metody   MeSH
• látky znečišťující půdu analýza   MeSH
• léčivé přípravky analýza   MeSH
• monitorování životního prostředí metody   MeSH
• odpadní vody chemie   MeSH
• půda chemie   MeSH
• tandemová hmotnostní spektrometrie metody   MeSH
• Publikační typ
• časopisecké články MeSH
• validační studie MeSH
• Názvy látek
• 2-propanol MeSH
• acetonitrile MeSH Prohlížeč
• acetonitrily MeSH
• látky znečišťující půdu MeSH
• léčivé přípravky MeSH
• odpadní vody MeSH
• půda MeSH