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PubMed Journals Articles About "Latest STAT Report Pharmalot Dives Into Regulatory Manufacturing" RSS

06:39 EDT 5th April 2020 | BioPortfolio

Latest STAT Report Pharmalot Dives Into Regulatory Manufacturing PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Latest STAT Report Pharmalot Dives Into Regulatory Manufacturing articles that have been published worldwide.

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Showing "latest STAT Report pharmalot dives into regulatory manufacturing" PubMed Articles 1–25 of 15,000+

Recent progress in continuous manufacturing of oral solid dosage forms.

Continuous drug product manufacturing is slowly being implemented in the pharmaceutical industry. Although the benefits related to the quality and cost of continuous manufacturing are widely recognized, several challenges hampered the widespread introduction of continuous manufacturing of drug products. Current review presents an overview of state-of-the art research, equipment, process analytical technology implementations and advanced control strategies. Additionally, guidelines and regulatory viewpoints ...


Automation in cell and gene therapy manufacturing: from past to future.

As more and more cell and gene therapies are being developed and with the increasing number of regulatory approvals being obtained, there is an emerging and pressing need for industrial translation. Process efficiency, associated cost drivers and regulatory requirements are issues that need to be addressed before industrialisation of cell and gene therapies can be established. Automation has the potential to address these issues and pave the way towards commercialisation and mass production as it has been t...

Latest advances in STAT signaling and function in adipocytes.

Adipocytes and adipose tissue are not inert and make substantial contributions to systemic metabolism by influencing energy homeostasis, insulin sensitivity, and lipid storage. In addition to well-studied hormones such as insulin, there are numerous hormones, cytokines, and growth factors that modulate adipose tissue function. Many endocrine mediators utilize the JAK-STAT pathway to mediate dozens of biological processes, including inflammation and immune responses. JAKs and STATs can modulate both adipocyt...


Observation of the Leptonic Decay D^{+}→τ^{+}ν_{τ}.

We report the first observation of D^{+}→τ^{+}ν_{τ} with a significance of 5.1σ. We measure B(D^{+}→τ^{+}ν_{τ})=(1.20±0.24_{stat}±0.12_{syst})×10^{-3}. Taking the world average B(D^{+}→μ^{+}ν_{μ})=(3.74±0.17)×10^{-4}, we obtain R_{τ/μ}=Γ(D^{+}→τ^{+}ν_{τ})/Γ(D^{+}→μ^{+}ν_{μ})=3.21±0.64_{stat}±0.43_{syst}., which is consistent with the standard model expectation of lepton flavor universality. Using external inputs, our results give values for the D^{+} decay constant f_{D^...

Diving behavior of the reef manta ray (Mobula alfredi) in New Caledonia: More frequent and deeper night-time diving to 672 meters.

The interest in reef manta rays (Mobula alfredi) from the scientific community is growing in reaction to the major decline of populations around the world. Studies have highlighted the need to further investigate the spatial ecology of this species to inform conservation and management initiatives. Here we briefly report the results from nine SPLASH10-F-321A pop-off satellite archival tags (PSAT-tags) deployed in New Caledonia that recorded the world's deepest known dives for reef manta rays. All tagged ind...

Improving patient outcomes with regenerative medicine: How Regenerative Medicine Manufacturing Society plans to move the needle forward in cell manufacturing, standards, 3D bioprinting, artificial intelligence-enabled automation, education, and training.

Regenerative Medicine Manufacturing Society (RMMS) is the first and only professional society dedicated toward advancing manufacturing solutions for the field of regenerative medicine. RMMS' vision is to provide greater patient access to regenerative medicine therapies through innovative manufacturing solutions. Our mission is to identify unmet needs and gaps in regenerative medicine manufacturing and catalyze the generation of new ideas and solutions by working with private and public stakeholders. We aim ...

Hipk is required for JAK/STAT activity during development and tumorigenesis.

Drosophila has been instrumental as a model system in studying signal transduction and revealing molecular functions in development and human diseases. A point mutation in the Drosophila Janus kinase JAK (called hop) causes constitutive activation of the JAK/STAT pathway. We provide robust genetic evidence that the Homeodomain interacting protein kinase (Hipk) is required for endogenous JAK/STAT activity. Overexpression of Hipk can phenocopy the effects of overactive JAK/STAT mutations and lead to melanized...

STAT-ART: The Promise and Practice of a Rapid Palliative Single Session of MR-Guided Online Adaptive Radiotherapy (ART).

This work describes a novel application of MR-guided online adaptive radiotherapy (MRgoART) in the management of patients whom urgent palliative care is indicated using statum-adaptive radiotherapy (STAT-ART). The implementation of STAT-ART, as performed at our institution, is presented including a discussion of the advantages and limitations compared to the standard of care for palliative radiotherapy on conventional c-arm linacs. MR-based treatment planning techniques of STAT-ART for density overrides and...

Requiem for the STAT Test: Automation and Point of Care Testing.

Quick turnaround of laboratory test results is needed for medical and administrative reasons. Historically, laboratory tests have been requested as routine or STAT. With a few exceptions, a total turnaround time of 90 minutes has been the usually acceptable turnaround time for STAT tests.

A study of decompression sickness using recorded depth-time profiles.

122,129 dives by 10,358 recreational divers were recorded by dive computers from 11 manufacturers in an exploratory study of how dive profile, breathing gas (air or nitrox [N2/O2] mixes), repetitive diving, gender, age, and dive site conditions influenced observed decompression sickness (DCSobs). Thirty-eight reports were judged as DCS. Overall DCSobs was 3.1 cases/10⁴ dives.

The role of JAK/STAT signaling pathway and its inhibitors in diseases.

The JAK/STAT signaling pathway is an universally expressed intracellular signal transduction pathway and involved in many crucial biological processes, including cell proliferation, differentiation, apoptosis, and immune regulation. It provides a direct mechanism for extracellular factors-regulated gene expression. Current researches on this pathway have been focusing on the inflammatory and neoplastic diseases and related drug. The mechanism of JAK/STAT signaling is relatively simple. However, the biologic...

Transitioning Chemistry, Manufacturing and Controls (CMC) Content with a Structured Data Management Solution: Streamlining Regulatory Submissions.

The process of assembling regulatory documents for submission to multiple global health agencies can present a repetitive cycle of authoring, editing, and data verification, which increases in complexity as changes are made for approved products, particularly from a chemistry, manufacturing, and controls (CMC) perspective. Currently, pharmaceutical companies rely on a workflow that involves manual CMC change management across documents. Similarly, when regulators review submissions, they provide feedback an...

25-Hydroxyvitamin D positively regulates periodontal inflammaging via SOCS3/STAT signaling in diabetic mice.

Diabetes is a known age-related disease. Inflammaging has recently been shown to result in diabetic complications. Vitamin D is related to aging in the latest study but little is known about the underlying mechanism. Here, we investigated the effects of 25-Hydroxyvitamin D (25(OH)D) on inflammaging in diabetic periodontitis, a common chronic inflammatory diabetic complication.

STAT Signaling in Glioma Cells.

STAT (signal transducers and activators of transcription) are latent cytoplasmic transcription factors that function as downstream effectors of cytokine and growth factor receptor signaling. The canonical JAK/STAT signaling pathway involves the activation of Janus kinases (JAK) or growth factors receptor kinases, phosphorylation of STAT proteins, their dimerization and translocation into the nucleus where STATs act as transcription factors with pleiotropic downstream effects. STAT signaling is tightly contr...

The potential and controversy of targeting STAT family members in cancer.

The Signal Transducer and Activator of Transcription (STAT) family of proteins consists of transcription factors that play a complex and essential role in the regulation of physiologic cell processes, such as proliferation, differentiation, apoptosis and angiogenesis, and serves to organize the epigenetic landscape of immune cells. To date, seven STAT genes have been identified in the human genome; STAT1, STAT2, STAT3, STAT4, STAT5a, STAT5b and STAT6. They all account for diverse effects in response to extr...

The effects of heliox non-saturation diving on the cardiovascular system and cognitive functions.

The purpose of this study was to investigate the effects of a single bout of heliox non-saturation diving on the cardiovascular system and cognitive function. Ten recreational scuba divers (10 males, ∼35 years old) participated in this study. These subjects made two pool dives within a one-week interval, alternating gases with compressed air (21% O2, 79% N2) and with heliox (21% O2 and 79% He). The depth was to 26 meters over a 20-minute duration. The results showed that heliox diving significantly increa...

Pulmonary barotrauma: a case report with illustrative radiology.

A case of a 24-year-old gentleman who had pulmonary barotrauma (PBT) after diving is reported. He presented with chest pain after the second of two uneventful shallow SCUBA dives. Computerized tomography (CT) scan confirmed the diagnosis and he was treated conservatively. Relevant radiology and a discussion of PBT are presented.

Scoping Review on the Use of Drugs Targeting JAK/STAT Pathway in Atopic Dermatitis, Vitiligo, and Alopecia Areata.

The JAK/STAT signaling pathway is involved in the immune-mediated inflammatory skin diseases atopic dermatitis (AD), vitiligo, and alopecia areata (AA), and represents a potential target when developing treatments. So far, no drugs targeting this pathway have been approved for the treatment of dermatological diseases. We reviewed the use of drugs blocking the JAK/STAT pathway in the aforementioned diseases.

A drone ducks, dips and dives to dodge obstacles in a flash.

The role of services content for manufacturing competitiveness: A network analysis.

This paper explores the phenomenon of international servicification of manufacturing from the period 1995 to 2011. By applying empirical techniques of Social Network Analysis and graph theory, we find that the network of flows of intermediate services embodied in manufacturing exports is still slightly dense and would not correspond to a traditional centre-periphery structure. The mapping shows a numerous, highly cohesive group of countries, with China, the USA and Germany as central economies and an increa...

Getting Information-STAT.

This issue of the Clinical Journal of Oncology Nursing (CJON) contains the inaugural installment of STAT, a visually compelling one-page review about oncologic emergencies or other clinical care issues that require urgent nursing attention. The reasons for STAT are simple. The need for nurses to have accessible and timely references to support clinical practice is well established. Studies consistently confirm that time management is a core nursing competency. To best manage that time, nurses who have ready...

The Current Status of the Production and Supply of Gallium-68.

Gallium-68 (Ga) is an important radionuclide due to its successful use in the clinic. Currently, Ga is produced and supplied by using germanium-68/Gallium-68 (Ge/Ga) generator systems in the preclinical and clinical environments. Until recently, the supply of Ge/Ga generators, specifically the good manufacturing practices (GMP) grade, had a long lead time (up to 18 months). This led researchers to investigate the cyclotron production of Ga by using solid and liquid targets. This report summarizes an overvie...

Accelerating the development of innovative cellular therapy products for the treatment of cancer.

The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US Food and Drug Administration and other agencies worldwide for two types of hematologic cancers. To facilitate the development of these therapies for patients with life-threatening cancers with limited or no therapeutic options, science- and risk-based approaches will be critical to mitigating and balancing any potential ...

Preservation of Soft Tissue Contours Using Computer-Aided Design/Computer-Assisted Manufacturing Healing Abutment with Guided Surgery in the Esthetic Area: Case Report.

This case report describes a digital workflow for a computer-aided design/computer-assisted manufacturing (CAD/CAM) healing abutment used in immediate implant placement in the esthetic zone. The design of the healing abutment was based on the existing tooth anatomy in order to provide anatomical support to the gingival tissues and to preserve the gingival contours of the natural tooth. This approach enhances the esthetic outcome of the definitive implant restoration. The surgical procedure including the gui...

Graduate Training Capacity for Regulatory Professionals at US Universities: Are We Facing a Talent Crisis?

Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally.


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