Clinical development of liposome-based drugs: formulation, characterization, and therapeutic efficacy

Research on liposome formulations has progressed from that on conventional vesicles to new generation liposomes, such as cationic liposomes, temperature sensitive liposomes, and virosomes, by modulating the formulation techniques and lipid composition. Many research papers focus on the correlation of blood circulation time and drug accumulation in target tissues with physicochemical properties of liposomal formulations, including particle size, membrane lamellarity, surface charge, permeability, encapsulation volume, shelf time, and release rate. This review is mainly to compare the therapeutic effect of current clinically approved liposome-based drugs with free drugs, and to also determine the clinical effect via liposomal variations in lipid composition. Furthermore, the major preclinical and clinical data related to the principal liposomal formulations are also summarized

The Regulation Requirement of Dengue Vaccines

Dengue fever (dengue), a mosquito-borne disease caused by dengue viruses (DENVs), represents severe public health problems in Southeast Asia, Latin America, Africa and other subtropical regions. Many regulatory issues arise along with the development of dengue vaccines. It is required to follow the regulatory pathway for the license application. Dengue vaccines can be approved without local clinical phase III data. The national regulatory authorities (NRAs) must have the information, training and ability to review and approve the application. A novel vaccine product Dengvaxia® for dengue has been approved in many countries. The approval is based on clinical trials that show the vaccine could reduce about 60% dengue, prevented 90% of severe cases and 80% of hospitalizations. Several other DNA, live-attenuated, purified inactivated, subunit, vectored and chimeric vaccine candidates are currently developing in clinical phases. Although there are still some challenges for the development and regulation of vaccine, the prospects of dengue vaccines are promising provided that we can overcome the difficulty

Biotechnologies Applied in Biomedical Vaccines

Vaccination, the administration of an antigenic material (vaccine), is considered to be the most effective method for disease prevention and control. A vaccine usually contains an agent that resembles a diseases‐causing pathogen and is often made from inactivated microbes, live attenuated microbes, its toxins, or part of surface antigens (subunit). However, the modern biotechnological tools and genomics have opened a new era to develop novel vaccines and many products are successfully marketing around the world. It is important to formulate and deliver these vaccines appropriately to maximize the potential advances in prevention, therapy, and vaccinology. New vaccines employing biotechnological innovations are helping us to change the way for illness prevention. The clinical application of vaccines will be diversified along with the development of biotechnologies. In modern society, the outbreak of many infectious diseases has decreased through vaccination, but the burden of noninfectious diseases is growing. The new biotechnologies may result in not only the appreciation of vaccines which are critical in inducing protection against an infectious disease but also the production of therapeutic vaccines which are effective for alldiseases including infectious and noninfectious diseases

Nanotechnologies Applied in Biomedical Vaccines

Vaccination, one of the most effective strategies to prevent infectious diseases, is the administration of antigenic materials to stimulate an individual’s immune system to develop adaptive immunity to a specific pathogen. Though it is so advantageous for diseases control and prevention, vaccines still have some limitations. Nanotechnology is an approach to prepare a novel biomedicine vaccine with the vaccine consumption and side effects significantly decreased. Regulation is the most important criterion for the development of nanovaccines. All marketing products have to meet the requirement of regulation. The fast-track designation potentially aids in the development and expedites the review of nanovaccines that show promises in an unmet medical need. Here, some successful nanovaccine products are introduced—Inflexal® V, Epaxal®, GardasilTM, and CervarixTM have been widely used for the clinical applications, which are delivered either in the form of virosomes or virus-like particles. Vaccines based on nanotechnology may overcome their original disadvantages and lead to the development of painless, safer, and more effective products

Experimental verification of a wireless sensing and control system for structural control using MR dampers

The performance aspects of a wireless ‘active’ sensor, including the reliability of the wireless communication channel for real-time data delivery and its application to feedback structural control, are explored in this study. First, the control of magnetorheological (MR) dampers using wireless sensors is examined. Second, the application of the MR-damper to actively control a half-scale three-storey steel building excited at its base by shaking table is studied using a wireless control system assembled from wireless active sensors. With an MR damper installed on each floor (three dampers total), structural responses during seismic excitation are measured by the system's wireless active sensors and wirelessly communicated to each other; upon receipt of response data, the wireless sensor interfaced to each MR damper calculates a desired control action using an LQG controller implemented in the wireless sensor's computational core. In this system, the wireless active sensor is responsible for the reception of response data, determination of optimal control forces, and the issuing of command signals to the MR damper. Various control solutions are formulated in this study and embedded in the wireless control system including centralized and decentralized control algorithms. Copyright © 2007 John Wiley & Sons, Ltd.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/56121/1/682_ftp.pd

Functional decline and mortality in long-term care settings: Static and dynamic approach

AbstractBackground/PurposeFunctional impairment is known to be associated with higher mortality risk and adverse health outcomes. However, little is known about whether functional decline could predict mortality among the elderly in the long-term care setting.MethodsThis is a prospective cohort study in two veteran homes in northern Taiwan with active use of the minimum data set (MDS). Evaluation tools retrieved from the MDS, including MDS Resource Utilization Group-III for Activities of Daily Living (RUG-III ADL), MDS Cognitive Scale, MDS Social engagement, triggers for resident assessment protocol (RAP) and Pain scale, were utilized for the analysis.ResultsA total of 1125 male participants were included in this study. The mean age of the participants was 83.1 ± 5.1 years, and 65 (5.8%) developed physical functional decline within a 6-month period. Participants with functional decline [odds ratio (OR) 2.305, 95% confidence interval (CI) 1.002–5.303], poor baseline functional status (OR 1.116, 95% CI 1.002–1.242), positive RAP triggers for dehydration (OR 13.857, 95% CI 3.07–62.543), and underlying chronic lung diseases (OR 2.279, 95% CI 1.149–4.522), depression (OR 2.994, 95% CI 1.161–7.721), and cancer (OR 3.23, 95% CI 1.078–9.682) were more likely to have an additional 12-month mortality. By contrast, Parkinsonism (OR 3.875, 95% CI 1.169–12.841), increase in sum of RAP triggers (OR 6.096, 95% CI 2.741–13.562), and positive RAP triggers for cognitive loss (OR 3.164, 95% CI 1.612–6.212) and mood (OR 2.894, 95% CI 1.466–5.71) are strong predictors for functional decline within 6 months.ConclusionPhysical function decline within 6 months predicted the subsequent 1-year mortality, whereas increased sum of RAP triggers and positive trigger for cognitive loss and mood were associated with functional decline