ABSTRACT
Due to the unique characteristics of nanomaterials (NM) there has been an increase in their use in nanomedicines and innovative medical devices (MD). Although large numbers of NMs have now been developed, comprehensive safety investigations are still lacking. Current gaps in understanding the potential mechanisms of NM-induced toxicity can make it challenging to determine the safety testing necessary to support inclusion of NMs in MD applications. This article provides guidance for implementation of pre-clinical tailored safety assessment strategies with the aim to increase the translation of NMs from bench development to clinical use. Integrated Approaches to Testing and Assessment (IATAs) are a key tool in developing these strategies. IATAs follow an iterative approach to answer a defined question in a specific regulatory context to guide the gathering of relevant information for safety assessment, including existing experimental data, integrated with in silico model predictions where available and appropriate, and/or experimental procedures and protocols for generating new data to fill gaps. This allows NM developers to work toward current guidelines and regulations, while taking NM specific considerations into account. Here, an example IATA for NMs with potential for direct blood contact was developed for the assessment of haemocompatibility. This example IATA brings together the current guidelines for NM safety assessment within a framework that can be used to guide information and data gathering for the safety assessment of intravenously injected NMs. Additionally, the decision framework underpinning this IATA has the potential to be adapted to other testing needs and regulatory contexts.
Subject(s)
Nanostructures , Toxicity Tests , Computer Simulation , Nanostructures/toxicity , Risk Assessment/methods , Toxicity Tests/methodsABSTRACT
Plaque control during the course of orthodontic treatment is not an easy task, and dental caries are not an unlikely complication. We examined the possibility of controlling dental caries with Nd-YAG laser irradiation in orthodontic patients. As a preliminary experiment, we used the Nd-YAG laser to irradiate an extracted tooth and then left it to soak in lactic acid. The decay of the tooth was evaluated with a scanning electron microscope (SEM); tooth decay was inhibited by the action of the laser. Twenty patients undergoing orthodontic treatment for early decalcification of the teeth (white spot lesions) were selected, and photographs were taken of their oral cavities. White spot lesions on the four incisors and two canines of the maxilla were traced on tracing paper, and their areas were calculated by computer. Ten of the patients received laser treatment and acidulated phosphate fluoride solution (APF); the other ten acted as the control group. Between 11 and 12 months later, we photographed the oral cavity as we had previously; the white spot lesions were again traced and their areas calculated. The changes in the areas of the white spots of the laser-irradiated and control groups showed the following increases: laser-irradiated group, 1.41 times; controls, 2.87 times. The difference was statistically significant. These results demonstrate that Nd-YAG laser irradiation with application of APF acts as an effective method of caries control during orthodontic treatment.
Subject(s)
Dental Caries/prevention & control , Dental Caries/radiotherapy , Laser Therapy , Orthodontic Appliances/adverse effects , Acidulated Phosphate Fluoride/therapeutic use , Child , Dental Caries/etiology , Humans , NeodymiumABSTRACT
Thirteen infertile women who had undergone tubal surgery within the previous year for the correction of tubal obstruction, were studied with both conventional and radionuclide hysterosalpingography. The studies were performed on the same day, were interpreted independently, and the results were then compared. Three cases were excluded from analysis because of the technical inadequacy of one of the studies. Assuming the findings of the conventional studies to represent "truth," the sensitivity, specificity and accuracy of the radionuclide studies were 100%, 60% and 80% respectively.
Subject(s)
Fallopian Tubes/diagnostic imaging , Hysterosalpingography , Infertility, Female/diagnosis , Technetium Tc 99m Aggregated Albumin , Female , Humans , Radionuclide ImagingABSTRACT
This article examines the implications for the educational preparation of therapeutic recreation specialists of fiscal management trends in health care. Selected questions related to identification of fiscal management competencies, undergraduate and graduate curricula, and research needs are discussed.
