- Front Matter
- 10.1080/17576180.2025.2458453
Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations.
- Jan 30, 2025
- Bioanalysis
- Saloumeh K Fischer
Publications from 2021 to 2026
Showing 10 of 78 papers
Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations.
Characterizing Lime- and Cement-Treated Soil with the PM Device at a Full-Scale Pavement Test Track
In this paper, the plastic mold compaction device (PM Device) was used successfully during full-scale construction of lime- and cement-stabilized pavement layers for which strict quality control measures were taken, such as multiple spread rate calibration, frequent moisture contents, and close attention to compaction timing and density measurements. Even with these precautions to minimize variability, there was quantifiable variation in density, unconfined compressive strength (UCS), and elastic modulus (E) for soil–cement and soil–lime mixtures. Over the 61-m test section, density varied by 5.2% for soil–cement and by 5.0% for soil–lime, UCS varied by 861 kPa for soil–cement and by 246 kPa for soil–lime, and E varied by 2,628 MPa for soil–cement and by 1,036 MPa for soil–lime. There also were noticeable differences in PM Device density and E measurements compared with nuclear gauge and falling weight deflectometer–calculated modulus. This paper also serves as the first known and documented use of the PM Device with lime-stabilized material, and is the first known and documented comparison of PM Device specimens and beams compacted with a Proctor hammer. Compared with other field projects in which the PM Device was implemented, the variability of density and UCS in this project was lower than in other typical Mississippi Department of Transportation (MDOT) projects. When using the data collected at the National Center for Asphalt Technology (NCAT) test track as a baseline for soil–cement materials, variability likely will be no less than 5% for density as a percentage of the target density and 75% for UCS as a percentage of the average UCS value when using current MDOT construction protocols.
Read moreEŞYA TAŞIMA HUKUKUNDA HASAR, ZIYA VE GECİKMEDEN DOĞAN BİLDİRİM SÜRELERİ
Bu çalışma altı bölümden oluşmaktadır. Çalışmamızın ilk bölümünde taşıma hukuku kapsamında bildirim kavramının hukuki niteliğine değinilerek hasar zıya ve gecikme kavramları açıklanmıştır. Ardından sırasıyla kara taşıma hukuku, hava taşıma hukuku, deniz taşıma hukuku, demiryolu ile taşıma hukuku ve multimodal taşıma hukuku; ulusal ve uluslararası mevzuat kapsamında ayrı ayrı değerlendirilmiştir. Çalışma boyunca görüleceği üzere ulusal mevzuatta düzenlenen bildirim süreleri uluslararası konvansiyonlarla belirlenen süreler birbiriyle örtüşmektedir. Şüphesiz bu durum taşıma hukuku pratiğini açık ve belirgin kılmaktadır. Meydana gelen bir zarardan dolayı hak sahibinin taşıyıcıya süresinde bildirimde bulunmaması, tüm taşıma sistemleri yönünden taşıyıcının eşyayı sözleşmeye uygun olarak taşıdığına karine oluşturmaktadır. Öte yandan taşıtan veya eşya üzerinde hak sahibi olan göndericinin süresinde bildirimin yapma külfetinin yanında eşyanın hasar, zıya ve gecikmeden dolayı zarara uğradığı hallerde ispat hukuku açısından birtakım tedbirler alması elzemdir. Çalışmamızda sadece eşya taşıma hukukundan doğan bildirim sürelerine yer verilmiştir. Bu kapsamda zamanaşımı ve hak düşürücü süre yönünden belirlenen süreler konumuz dışında kaldığından bunlara çalışmamızda yer verilmemiştir.
Read moreReview on Plasma-Assisted Ignition Systems for Internal Combustion Engine Application
Due to the depletion of conventional petroleum-based fuels and increasing environmental concerns, industries have been developing new combustion technologies with acceptable cost ranges and minimum system modifications for consumers. Among many approaches, the utilization of plasma ignition systems is considered as a promising pathway to achieve greener transportation while maintaining conventional internal combustion engine systems. Plasma contains highly reactive radicals, and those have a great potential of enhancing chemical reactions that are beneficial for reducing carbon emissions. The primary objective of this paper is to provide an overview of currently available plasma-assisted combustion systems including recent achievements in research and development, and technical challenges for successfully implementing a new ignition system. This review will introduce various plasma-assisted combustion approaches from worldwide projects, covering non-thermal and thermal plasma systems in internal combustion engines.
Read moreApplication of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma
PurposeThe established two-analyte integrated population pharmacokinetic model was applied to assess the impact of intrinsic/extrinsic factors on the pharmacokinetics (PK) of polatuzumab vedotin (pola) in patients with non-Hodgkin lymphoma (NHL) following bodyweight-based dosing.MethodsModel simulations based on individual empirical Bayes estimates were used to evaluate the impact of intrinsic/extrinsic factors as patient subgroups on Cycle 6 exposures. Intrinsic factors included bodyweight, age, sex, hepatic and renal functions. Extrinsic factors included rituximab/obinutuzumab or bendamustine combination with pola and manufacturing process. The predicted impact on exposures along with the established exposure-response relationships were used to assess clinical relevance.ResultsNo clinically meaningful differences in Cycle 6 pola exposures were found for the following subgroups: bodyweight 100–146 kg versus 38–<100 kg, age ≥ 65 years versus <65 years, female versus male, mild hepatic impairment versus normal, mild-to-moderate renal impairment versus normal. Co-administration of rituximab/obinutuzumab or bendamustine, and change in the pola manufacturing process, also had no meaningful impact on PK.ConclusionsIn patients with NHL, bodyweight-based dosing is adequate, and no further dose adjustment is recommended for the heavier subgroup (100–146 kg). In addition, no dose adjustments are recommended for other subgroups based on intrinsic/extrinsic factors evaluated.
Read moreEvolución y desarrollo del concepto de competitividad y prospectiva
El libro “Construyendo Escenarios Prospectivos para los Desafíos del Desarrollo del Departamento de Sucre, Colombia”, que se presenta por la Gobernación de Sucre y Colciencias al país, es una unión de voluntades que se ha propuesto trabajar por el Departamento, con el objetivo de estudiar y fortalecer su Competitividad, haciendo presentes los retos y desafíos en una amplia gama de Sectores. Destacando, de igual forma, las oportunidades que este presenta, y ofreciendo, además, estudios prospectivos que, desde el futuro, miran hacia el presente, indicando la senda que deben seguir los actores involucrados para construir, a partir del hoy, ese mañana deseado para el Departamento, aprovechando al máximo sus recursos y mejorando las condiciones de su población.
Read moreImmunogenicity Risk Assessment for PEGylated Therapeutics.
The objective of this manuscript is to provide the reader with two examples on how to present an immunogenicity risk assessment for a PEGylated therapeutic as part of Investigational New Drug (IND) application or during other stages of the drug development process. In order to provide context to the bioanalytical strategies used to support the PEGylated therapeutics presented here, a brief summary of information available for marketed PEGylated biologics is provided. Two case studies are presented, a PEGylated enzyme and a PEGylated growth factor. For the former, the risk assessment covers how to deal with a narrow therapeutic window and suggestions to utilize a PD marker as surrogate for neutralizing antibody assessments in Phase I. The latter has recommendations on additional analytes that should be monitored to mitigate risk of immunogenicity to endogenous counterparts.
Read moreAux commencements était la haine…
Analytical convergence in surrogate control matrices.
How Does Presence of a Human Operator Companion Influence People’s Interaction with a Robot?
It is increasingly common for people to work alongside robots in a variety of situations. When a robot is completing a task, the human operator of the robot may be present at the work site or operating remotely. It is important to understand how people’s behavior towards a robot is influenced by the presence or absence of the operator. We observed individuals in public locations as they pass by a robot with and without a visible human operator. We show that individuals were more likely to approach and interact with the robot when it was alone. Also, individuals that interacted with the robot when it was alone were more likely to take extra candy from the robot. Our results suggest that robots with visible operators discourage interaction with the robot but encourage honesty in interactions with the robot.
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