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Results for “ETHICS, PHARMACEUTICAL”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 1,261 records · Page 70Linked to original sources
PubMed2006

Biased underreporting of research is unethical and should be outlawed.

Biased underreporting and multiple or selective publications of clinical trials harm and sometimes kill patients. Publicly funded researchers are not innocent of this form of scientific misconduct, but it is a particular problem in industry-sponsored research. So far, only six pharmaceutical companies have endorsed the "Good Publication Practice for Pharmaceutical Companies Guidelines". It is necessary to register all clinical trials publicly, at inception. Drug companies should be forced to publish all results, regardless of outcome.

Ethics, Research↗
PubMed1990

[Transgenesis; applications, welfare and ethics].

Biomedical proteins and proteins having a nutritional function can be produced in large quantities (as well as cheap) in the mammary gland of mammals such as cows. Several of these proteins are of major economic importance and will result in several new uses for milk. For example, milk of genetically modified cows will be produced especially for branches of the pharmaceutical industry or for the baby food industry. Production of these new proteins will not have any injurious effects on the animal as proteins in the mammary gland are characterised by the fact that they follow a one-way course.

Animals↗
PubMed2006

[In order to perform clinical trials efficiently in Japan--important issues in medical institutions raised by the GCP on-site review].

The guidelines for Good Clinical Practice (GCP) in Japan have been harmonized with ICH-GCP. Both the protection of human rights and the carrying out of clinical trials ethically and scientifically, conforming to the GCP, are necessary for the safety and efficacy of clinical data of common technical documents. It is standard practice in Japan, the U.S., and the E.U. to ensure conformity with all data from raw data to application materials. In April, 2004, the new independent organization Pharmaceuticals and Medical Devices Agency (PMDA) was established in Japan. The PMDA provides services focusing on the three key areas of Review, Safety, and Relief. The Office of Conformity Audit is one of the offices in the Center for Product Evaluation of the PMDA. In the conformity audit service of the Office of Conformity Audit of the PMDA, the reliability and conformity with the GCP between case report forms (CRFs) as basis materials and application materials is confirmed by the document-based conformity review, and the conformity between medical records as raw data and CRFs is assessed through the on-site GCP review. Therefore, such application materials are considered to be consistent with international standards. The important issues raised by the GCP on-site review by the Office of Conformity Audit of the PMDA are summarized in this study. We hope that our findings at investigational sites will promote the protection of human rights and improve the quality of clinical trials in Japan.

Clinical Protocols↗
PubMed1995

The prescription as final common pathway.

There is an informational void about pharmaceuticals in the training of most doctors, despite the importance of the prescription in medical care. The writing of the prescription is the final common pathway in therapeutic decision making, which involves such diverse forces and disciplines as anthropology, decision science, health economics, ethics, and politics, as well as pharmacology and clinical medicine. Programs to improve the precision and cost-effectiveness of doctors' prescribing must consider all of these factors if pharmacotherapeutics are to be used optimally.

Aged↗
PubMed2005

AQUAVAN injection, a water-soluble prodrug of propofol, as a bolus injection: a phase I dose-escalation comparison with DIPRIVAN (part 1): pharmacokinetics.

BACKGROUND: AQUAVAN Injection (AQ) (GPI 15715; Guilford Pharmaceutical Inc., Baltimore, MD) is a water-soluble prodrug of propofol (PropofolGPI). This study aimed to explore the pharmacokinetics of AQ, PropofolGPI, and formate (a metabolite of AQ) and to compare them with the pharmacokinetics of propofol lipid emulsion (PropofolD). METHODS: After ethics committee approval, 36 healthy volunteers were randomly allocated into six cohorts (male/female: 3/3) and given a single bolus of AQ (5, 10, 15, 20, 25, or 30 mg/kg). For comparison, an equipotent dose (as measured by the Bispectral Index) of PropofolD was given to the same subjects 1 week later. For both drugs, blood samples were collected (1-480 min) to analyze AQ, PropofolGPI, PropofolD, and formate concentrations. Noncompartmental pharmacokinetic analyses were performed for all analytes. A population compartmental model was developed for AQ and PropofolGPI using NONMEM. The models were evaluated using simulations and bootstraps. RESULTS: The noncompartmental pharmacokinetic comparison revealed different dispositions of PropofolGPI and PropofolD. The maximum plasma concentration was lower for PropofolGPI than for PropofolD at equipotent doses, and apparent clearance and distribution volume were much higher for PropofolGPI than for PropofolD. Formate concentrations were similar when injecting both drugs and were not higher than baseline. Compartmental modeling revealed that the pharmacokinetic behavior of AQ and its liberated PropofolGPI was best described by a nonlinear, six-compartment model, composed of two three-compartment models connected to each other by hydrolysis of AQ to PropofolGPI. CONCLUSIONS: PropofolGPI showed different noncompartmental pharmacokinetics from PropofolD, hereby revealing the influence of the formulation. The combined model for AQ and PropofolGPI was best modeled by a nonlinear, six-compartment model.

Adolescent↗
PubMedDate not supplied

Clinical trials in Alzheimer disease: debate on the use of placebo controls.

During the past 10 years, there has been a rapidly growing number of pharmaceutical industry-sponsored drug trials for treatment of Alzheimer disease (AD) and other neurodegenerative diseases. As public awareness and concerns about AD have grown, so has interest in developing drug therapies for retarding symptom progression, delaying onset, and ultimately curing the disease. Ethical debate on the use of placebo control trials in AD research has come of age in the United States with the availability of treatments approved by the Food and Drug Administration. The experts and the public agree that more effective therapies are necessary, and new therapeutic options are being developed as rapidly as possible. The arguments on each side of the debate are provocative and important but do not provide unequivocal justification for either the abandonment or the maintenance of placebo-controlled trials in all AD research. Clinical trials differ with respect to scientific and practical goals, and these factors inherently affect the ethical priorities of each study. We present these contrasting points of view to delineate some of the issues rather than to make specific recommendations other than to urge that all clinical trials in AD should be designed with careful consideration of the ethical issues surrounding the use of placebo controls. As new and more effective treatments emerge, the ethical framework for placebo use in AD studies will require frequent re-examination. To make wise choices, patients, caregivers, physicians, and ethicists (among others) must have a voice in this continuing discussion.

Alzheimer Disease↗
PubMed2003

Behavioral evaluation of the psychological welfare and environmental requirements of agricultural research animals: theory, measurement, ethics, and practical implications.

The welfare of agricultural research animals relies not only on measures of good health but also on the presence of positive emotional states and the absence of aversive or unpleasant subjective states such as fear, frustration, or association with pain. Although subjective states are not inherently observable, their interaction with motivational states can be measured through assessment of motivated behavior, which indicates the priority animals place on obtaining or avoiding specific environmental stimuli and thus allows conclusions regarding the impact of housing, husbandry, and experimental procedures on animal welfare. Preference tests and consumer demand models demonstrate that animal choices are particularly valuable when integrated with other behavioral and physiological measurements. Although descriptive assessments of apparently abnormal behavior such as stereotypies and "vacuum behaviors" provide indications of potentially impoverished environments, they should be used with some caution in drawing welfare conclusions. The development of stereotypies may in some cases be linked to psychiatric dysfunction and reflect underlying neurophysiological impairments, which have implications for the ability to perform flexible behavior and thus the quality of research data provided by this kind of behavioral measurement (e.g., in pharmaceutical research). Environmental modifications, commonly termed "enrichment," can have diverse consequences for cognitive function, physiological responses, health, psychological welfare, and research data. Simple practical modifications of housing, husbandry, and experimental design are suggested to improve the psychological welfare of agricultural research animals in accordance with the principles of refining, reducing, and replacing (the "3Rs"), which underlie US Public Health Service Policy, and prevailing public ethics.

Animal Husbandry↗
PubMed2003

[Administrative organization and responsibility].

The paper describes the current organisation of clinical trials in Danish hospitals, with particular emphasis on the relationship between hospitals and the pharmaceutical industry. Legal responsibilities as well as mutual agreements on collaboration and organisation are described and discussed.

Clinical Trials as Topic↗
PubMed1995

Setting priorities in the Spanish health care system.

Increasingly sophisticated and expensive medical technologies, chronic illness and aging, and a population that insists upon the best health care and coverage, together demand that priorities be set in the public funding of health care. This article describes Spanish initiatives in dealing with such problems and analyses the ethical implications of health care legislation and rationing.

Aging↗
PubMed2005

Understanding of genetic information in higher secondary students in northeast India and the implications for genetics education.

Since the work of Watson and Crick in the mid-1950s, the science of genetics has become increasingly molecular. The development of recombinant DNA technologies by the agricultural and pharmaceutical industries led to the introduction of genetically modified organisms (GMOs). By the end of the twentieth century, reports of animal cloning and recent completion of the Human Genome Project (HGP), as well techniques developed for DNA fingerprinting, gene therapy and others, raised important ethical and social issues about the applications of such technologies. For citizens to understand these issues, appropriate genetics education is needed in schools. A good foundation in genetics also requires knowledge and understanding of topics such as structure and function of cells, cell division, and reproduction. Studies at the international level report poor understanding by students of genetics and genetic technologies, with widespread misconceptions at various levels. Similar studies were nearly absent in India. In this study, I examine Indian higher secondary students' understanding of genetic information related to cells and transmission of genetic information during reproduction. Although preliminary in nature, the results provide cause for concern over the status of genetics education in India. The nature of students' conceptual understandings and possible reasons for the observed lack of understanding are discussed.

Cells↗