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At least 325 records · Page 18Linked to original sources
PubMed2006

Immune function tests for hazard identification: a paradigm shift in drug development.

Routine immune function testing in preclinical drug development was established as a regulatory requirement in June of 2000 under the Committee of Proprietary Medicinal Products (CPMP) Note for Guidance on Repeated Dose Toxicity (CPMP/SWP/1042/99). The purpose of the more stringent approach to immunotoxicology testing was to better identify unintended immunosuppression; however, the requirement was met with much discussion and debate. At the center of the discussion was an attempt to reconcile opposing regulatory directives from agencies outside of Europe that adhere to a more selective, weight-of-evidence approach to functional evaluations. Uncertainty over the predictive value of the recommended immune function tests relative to conventional toxicology parameters prompted an investigation by the International Committee on Harmonization (ICH). The results of a preliminary, industry-wide survey indicated that only a low percentage of pharmaceuticals adversely affect immune function without alterations to standard toxicology parameters. Expected ICH guidelines will ultimately determine to what extent and for what purpose immune function tests will be conducted. In the meantime, optimization of the recommended immune function tests is ongoing. The T-cell dependent antibody response (TDAR) by either conventional Sheep Red Blood Cell (SRBC) plaque assay or by the modified ELISA method using either SRBC or keyhole limpet hemocyanin (KLH) as antigen is being extensively evaluated to determine best practices and procedures for preclinical immunotoxicity evaluations. This review addresses some aspects of the debate concerning the appropriateness of immune function tests for hazard identification, along with recommendations for optimizing TDAR methodology to ensure adequate sensitivity and predictability in risk assessments for immunotoxicity.

Animals↗
PubMed2006

Paradigm shifts in inpatient psychiatric care of children: approaching child- and family-centered care.

TOPIC: This article describes the components of child- and family-centered care, including a review of the literature about the delivery of family-centered care and the barriers that often prevent the provision of such care. The article describes an inpatient child psychiatric unit that has implemented an approach to care that embraces these principles. The changes in structures and policies that the unit adopted are described, with specific examples cited as illustrations of the components of this care. PURPOSE: To describe the elements of child- and family-centered care and the ways in which this model of care may be implemented on inpatient child psychiatric units. SOURCES USED: Literature review including journal reports and articles and books. CONCLUSIONS: Preliminary outcomes are encouraging in the decrease in use of practices such as restraint and seclusion, and physical holds. Further research examining parents' satisfaction is warranted in determining the success of such endeavors.

Child↗
PubMed2002

Wildlife and pastoral society--shifting paradigms in disease control.

The dramatic changes in the human and animal populations in Africa over the last century demand the re-examination of priorities and policies. The introduction of developed medical and other human technologies into the continent has contributed to increases in population and a rapid, unsustainable increase in the utilization of resources. This in turn has led to the destruction of flora and fauna on an unprecedented scale with little real improvement in the human condition. One factor in this has been the increase in livestock in line with human demographic growth, as it is a traditional livelihood of many African peoples. In recent years the growth in livestock populations has slowed owing to a cycle of degradation and disease, affecting especially traditional pastoral systems with a close physical association between people, livestock, and wild animals. Pathogens benefit hugely from the dynamic state created by animal migration, although to some extent the livestock and certainly wildlife show considerable tolerance to this. One of the grave economic consequences of this increase in disease has been collapse of the export trade. In order for Africa to fully benefit and share in world trade, the zoosanitary situation must show improvement. To do this without destroying the natural resource base and traditional pastoral systems, will require a careful, future-oriented land-use policy along ecologically sound criteria. Export livestock will have to be maintained in areas, probably free of ruminant wildlife, with strict veterinary controls. If this can be balanced with sufficient areas retained for traditional pastoralism and wildlife, with perhaps the main income from recreational tourism and local consumption, the benefits will be considerable. The answer may be community-based, low-cost, decentralized health systems for pastoral communities, with less stringent sanitary mandates, a private/parastatal sector servicing, with specialization in wildlife, dairy or export livestock and a central veterinary policy, related to surveillance and monitoring using small well-resourced professional teams to carry out regulatory and statutory duties.

Africa↗
PubMed1998

Epidemiology of group B streptococcal disease in the United States: shifting paradigms.

Since its emergence 25 years ago, group B streptococcus has become recognized as a cause of serious illness in newborns, pregnant women, and adults with chronic medical conditions. Heavy colonization of the genital tract with group B streptococcus also increases the risk that a woman will deliver a preterm low-birthweight infant. Early-onset infections (occurring at < 7 days of age) are associated with much lower fatality than when they were first described, and their incidence is finally decreasing as the use of preventive antibiotics during childbirth increases among women at risk. New serotypes of group B streptococcus have emerged as important pathogens in adults and newborns. Clinical and laboratory practices--in obstetrics, pediatrics, and clinical microbiology--have an impact on disease and/or its prevention, and protocols established at the institutional level appear to be critical tools for the reduction of perinatal disease due to group B streptococcus. Since intrapartum antibiotics will prevent at best only a portion of the full burden of group B streptococcal disease, critical developments in vaccine evaluation, including study of polysaccharide-protein conjugate vaccines, offer the potential for enhanced prevention in the relatively near future.

Adult↗
PubMed1996

The statistical basis of public policy: a paradigm shift is overdue.

The recent controversy over the increased risk of venous thrombosis with third generation oral contraceptives illustrates the public policy dilemma that can be created by relying on conventional statistical tests and estimates: case-control studies showed a significant increase in risk and forced a decision either to warn or not to warn. Conventional statistical tests are an improper basis for such decisions because they dichotomise results according to whether they are or are not significant and do not allow decision makers to take explicit account of additional evidence--for example, of biological plausibility or of biases in the studies. A Bayesian approach overcomes both these problems. A Bayesian analysis starts with a "prior" probability distribution for the value of interest (for example, a true relative risk)--based on previous knowledge--and adds the new evidence (via a model) to produce a "posterior" probability distribution. Because different experts will have different prior beliefs sensitivity analyses are important to assess the effects on the posterior distributions of these differences. Sensitivity analyses should also examine the effects of different assumptions about biases and about the model which links the data with the value of interest. One advantage of this method is that it allows such assumptions to be handled openly and explicitly. Data presented as a series of posterior probability distributions would be a much better guide to policy, reflecting the reality that degrees of belief are often continuous, not dichotomous, and often vary from one person to another in the face of inconclusive evidence.

Attitude to Health↗