PubMed Journals Articles About "Drug Industry Dynamics Shaping CDMO Sector" RSS

01:15 EST 21st November 2018 | BioPortfolio

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Showing "Drug Industry Dynamics Shaping CDMO Sector" PubMed Articles 1–25 of 16,000+

Fostering the Catalyst Role of Government in Advancing Healthy Food Environments.

Effective approaches to non-communicable disease (NCD) prevention require intersectoral action targeting health and engaging government, industry, and society. There is an ongoing vigorous exploration of the most effective and appropriate role of government in intersectoral partnerships. This debate is particularly pronounced with regards to the role of government in controlling unhealthy foods and promoting healthy food environments. Given that food environments are a key determinant of health, and the com...

Improvement of the safety and quality of a workplace in the area of the construction industry with the use of the 6S system.

The paper presents the development of a standard approach to the improvement of workplace quality (5S system) with an additional S-Safety step, creating an approach called the 6S system. The article describes a conducted literature survey on the use of the standard 5S system in the construction sector and the 6S system in the manufacturing industry. On the basis of the carried out analysis, the method of implementing the 6S system in the construction sector was proposed, while indicating how an additional "...

Molecular Dynamics Simulations of Supramolecular Anticancer Nanotubes.

We report here on long-time all-atomistic molecular dynamics simulations of functional supramolecular nanotubes composed by the self-assembly of peptide-drug amphiphiles (DAs). These DAs have been shown to possess an inherently high drug loading of the hydrophobic anticancer drug camptothecin. We probe the self-assembly mechanism from random with ~ 0.4 microsecond molecular dynamics simulations. Furthermore, we also computationally characterize the interfacial structure, directionality of π-π stacking, an...

Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.

Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over tim...

Anticipating Industry Arguments: The US Food and Drug Administration's Authority to Reduce Nicotine Levels in Cigarettes.

The US Food and Drug Administration has announced that it is considering lowering nicotine levels in cigarettes to "minimally addictive or nonaddictive levels." This could be a transformative public health measure, but the tobacco industry is likely to challenge such an action in court. This article reviews some of the key legal arguments that industry is likely to advance and considers possible responses. As we demonstrate, there are strong arguments that the US Food and Drug Administration has the authori...

Within-host competition can delay evolution of drug resistance in malaria.

In the malaria parasite P. falciparum, drug resistance generally evolves first in low-transmission settings, such as Southeast Asia and South America. Resistance takes noticeably longer to appear in the high-transmission settings of sub-Saharan Africa, although it may spread rapidly thereafter. Here, we test the hypothesis that competitive suppression of drug-resistant parasites by drug-sensitive parasites may inhibit evolution of resistance in high-transmission settings, where mixed-strain infections are c...

Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries.

Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European Union member countries, to clarify the industry perspective.

Industry and geographic patterns of use and emission of carcinogens in Ontario, Canada, 2011-2015.

The goal of this study was to leverage data from two environmental regulatory initiatives, Ontario's Toxics Reduction Act (TRA) and Canada's National Pollutant Release Inventory (NPRI), to assess their ability to monitor trends in the use and emission of carcinogens by industry sector in Ontario.

The Current Status of Drug Discovery and Development as Originated in US Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development.

Academic drug discovery is a vital component to current drug discovery and development environments. In this study we investigated 798 drug discovery projects that took place between 1991 and 2015 at 36 academic institutions in the US. The observed success rates of academic drug discovery and development were 75% at Phase 1, 50% at Phase 2, 59% at Phase 3, and 88% at the new drug application/biologics license application (NDA/BLA) phase. These results were similar to the corresponding success rates of the p...

A pharmaceutical industry perspective on transporter and CYP-mediated drug-drug interactions: kidney transporter biomarkers.

Technical quality of delivery care in private- and public-sector health facilities in Enugu and Lagos States, Nigeria.

Private-sector providers are increasingly being recognized as important contributors to the delivery of healthcare. Countries with high disease burdens and limited public-sector resources are considering using the private sector to achieve universal health coverage. However, evidence for the technical quality of private-sector care is lacking. This study assesses the technical quality of maternal healthcare during delivery in public- and private-sector facilities in resource-limited settings, from a systems...

Orphan drugs: trends and issues in drug development.

Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan dru...

HIV-1 drug resistance among Ugandan adults attending an urban out-patient clinic.

Little is known about prevalence of drug resistance among HIV-infected Ugandans, a setting with over 15 years of public-sector access to antiretroviral therapy (ART) and where virological monitoring was only recently introduced.

Seagrass and macrophyte mediated CO2 and CH4 dynamics in shallow coastal waters.

Seagrass meadows are among the most important coastal/ marine ecosystems for long-term carbon storage and conditioning of coastal waters. A combined air-water flux of CO2 and CH4 from the seagrass meadows was studied for the first time from Asia's largest brackish-water lagoon, Chilika, India. Ecosystem-based comparisons were carried out during two hydrologically different conditions of dry and wet seasons in the seagrass dominated southern sector (SS); macrophyte-dominated northern sector (NS); the largely...

From waste to resource: A systems dynamics and stakeholder analysis of phosphorus recycling from municipal wastewater in Europe.

Recycling Phosphorus (P) from urban wastewater can secure part of domestic agricultural P supply and contribute to a circular P supply chain. In this paper, we use literature review, stakeholder interviews and analysis, and systems dynamics for the capital cities of Stockholm and Budapest as case studies. We find that political support is a prerequisite for developing the P recycling sector, and policy makers are the most influential stakeholders. P criticality is the main driver for political support. P ex...

Use of cross-sector apprenticeships in pharmacy: is it a sustainable quality education model for pharmacy assistants?

To establish whether undertaking cross-sector pharmacy apprenticeship training to become a pharmacy assistant equally split across the two main pharmacy sectors improves training experience and cross-sector understanding.

Spending on Antineoplastic Agents in the United States, 2011 to 2016.

Recent cancer drug approvals are lauded as being more effective with relatively fewer adverse effects, but these treatments come with a great cost to the US health care system. There is little information on recent trends in actual antineoplastic expenditures representative of the whole US health care system or by sector. Therefore, the objective of this study was to describe antineoplastic expenditures in the United States by year and sector.

All-atomistic molecular dynamics (AA-MD) studies and pharmacokinetic performance of PAMAM-dendrimer-furosemide delivery systems.

Improvement of problematic dissolution and solubility properties of a model drug, furosemide, was investigated for poly(amidoamine) (PAMAM) dendrimer complexes of the drug. Full and half generation dendrimers with amino and ester terminals respectively, were studied. In vitro release performance of these complexes was investigated at drug loads ranging 5-60% using simulated gastric fluids. Full generation dendrimers accommodated higher drug loads, outperformed half-generation complexes, and free drug. Pharm...

Emergence and selection of isoniazid and rifampin resistance in tuberculosis granulomas.

Drug resistant tuberculosis is increasing world-wide. Resistance against isoniazid (INH), rifampicin (RIF), or both (multi-drug resistant TB, MDR-TB) is of particular concern, since INH and RIF form part of the standard regimen for TB disease. While it is known that suboptimal treatment can lead to resistance, it remains unclear how host immune responses and antibiotic dynamics within granulomas (sites of infection) affect emergence and selection of drug-resistant bacteria. We take a systems pharmacology ap...

U-BIOPRED: evaluation of the value of a public-private partnership to industry.

Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) was initiated in the first year of the Innovative Medicines Initiative (IMI). It was an ambitious plan to tackle the understanding of asthma through an integration of clinical and multi-'omics approaches that necessitated the bringing together of industry, academic, and patient representatives because it was too large to be managed by any one of the partners in isolation. It was a novel experience for all concerned. In this r...

DairyWater: striving for sustainability within the dairy processing industry in the Republic of Ireland.

This Review describes the objectives and methodology of the DairyWater project as it aims to aid the Irish dairy processing industry in achieving sustainability as it expands. With the abolition of European milk quotas in March 2015, the Republic of Ireland saw a surge in milk production. The DairyWater project was established in anticipation of this expansion of the Irish dairy sector in order to develop innovative solutions for the efficient management of water consumption, wastewater treatment and the re...

Industry Payments to Physicians and Prescriptions of Brand-Name Proton-Pump Inhibitors.

Objective To characterize the association between industry payments and prescriptions of 2 brand-name proton-pump inhibitors (PPIs). Study Design Cross-sectional retrospective. Setting Physicians nationwide. Subjects and Methods We identified all physicians receiving industry payments for Dexilant and Nexium 2014-2015 from the Open Payments database. We linked this to records of prescriptions for PPIs paid for by Medicare Part D these same years and compared the proportion of prescriptions written for Dexil...

Willingness to pay for health insurance in the informal sector of Sierra Leone.

The objective of this project is to study the willingness to pay (WTP) for health insurance (HI) of individuals working in the informal sector in Sierra Leone, using a purposely-designed survey of a representative sample of this sector.

Investigation of Drug Delivery in Rats via Subcutaneous Injection: Case Study of Pharmacokinetic Modeling of Suspension Formulations.

With the rising cost of drug research, "do more with less" has become a new emphasis in the pharmaceutical industry. Consequently, the early analysis of PK/PD, efficacy, and safety parameters for a new drug target is critical for ensuring informed decision-making as soon as possible during the drug discovery process. When ADME properties of compounds are suboptimalwhich is especially true during the early stages of drug discovery, obtaining the desired exposure can be challenging via the most common routes ...

Steered Molecular Dynamics Simulation in Rational Drug Design.

Conventional de novo drug design is time consuming, laborious, and resource intensive. In recent years, emerging in-silico approaches have been proven to be critical to accelerate the process of bringing drugs to market. Molecular dynamics (MD) simulations of single molecule and molecular complexes have been commonly applied to achieve accurate binding modes and binding energies of drug-receptor interactions. A derivative of MD, namely steered molecular dynamics (SMD), has been demonstrated as a promising t...

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