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At least 1,297 records · Page 72Linked to original sources
PubMed2001

Money or your life? The health-wealth trade-off in pharmaceutical regulation.

For decades the development of pharmaceuticals has been regulated by safety, efficacy and quality rules for product registration. In public health care systems, these three 'hurdles' are increasingly being supplemented by a fourth: the mandatory requirement to demonstrate economic efficiency in order to obtain reimbursement. This requirement challenges the wealth creation ethic of industry (money) with the population health ethic of public health and health economics (your life). Despite practical and methodological obstacles to the use of economic evidence in decisions, the logic of this development is evident: in order to maximise improvements in population health, scarce resources must be targeted towards developing and applying technologies that deliver the greatest health gains per unit cost. The impact of this policy change on industry practice and profits will be considerable, and companies that fail to demonstrate the economic efficiency of their products will stumble at the fourth hurdle.

Community Health Planning↗
PubMed2004

[Clinical research with pharmaceutical agents in Germany: effects of the 12th amendment to the German Drug Law].

The European Clinical Trials Directive came into force on April 4th, 2001. This regulation will be implemented into the German Drug Law (AMG) through the 12th amendment to the AMG. It will impose major changes on the preparation and conduct of clinical studies with medicaments. In particular, the procedure to gain an ethical committee's approval and permission for multicentric studies from the German Federal Authority (BfArM) will increase bureaucracy and complexity for the sponsor. The new German procedures, which by far exceed the European regulation, will lead to increased costs and will require more time for the preparation of clinical studies.

Clinical Trials as Topic↗
PubMed1988

Designer drugs: past history and future prospects.

Historically, drugs of abuse have come from two sources: plant products and diverted pharmaceuticals. Today, new, totally synthetic drugs produced by clandestine laboratories have become an increasingly important source of abused substances. Of particular concern are the fentanyls, a family of very potent narcotic analgesics, which first appeared on the streets in California in 1979 under the name "China White". At least 10 different analogs have been identified to date and are thought to be responsible for over 100 overdose deaths. The fentanyls are not used by any particular ethic or age group, but rather by the general heroin using population. Their use, however, does seem to be restricted to suburban, rather than urban areas, and almost exclusively to the state of California. The most potent analogs, the 3-methyl- and beta-hydroxy-fentanyls, may be up to 1000 times as potent as heroin, but are not chemically related to the opiates and therefore not detected by conventional narcotic screening tests. However, using a sensitive radioimmunoassay highly specific for the fentanyls they can be measured at the very low concentrations observed in body fluids, generally less than 10 ng/mL. It is likely that, as efforts to restrict the importation of natural products and prevent diversion of pharmaceuticals become more effective, the fentanyls and other synthetics will become increasingly important drugs of abuse.

Adult↗
PubMed2003

Development pharmaceutics of microbicide formulations. Part I: preformulation considerations and challenges.

Microbicides, the compounds and formulations that can prevent transmission of sexually transmitted diseases (STDs)/HIV are being pursued actively as a promising AIDS intervention. The drug development chain for a topical microbicide differs significantly from that of any systemic or topical compound/formulation regarding to time line, cost, activities, and milestones. This is in part because of the lack of standard in vitro models to assess efficacy, and complex ethical issues in clinical trials of microbicides. Several factors, including changes in the physiology of the cervix and vagina with age and menstrual cycle, intercourse, as well as leakage of the formulation from the vagina may affect their design, development, and performance. Selection and development of optimal microbicide delivery systems (gel/cream, pessary, film, tablet, foam, etc.), their inactive ingredients, manufacturing details, and packaging system are dependent on the properties of active drug, or their preformulation parameters (PP). The PP of the active drug substance needs to be evaluated in initial stages of drug discovery and development so that the most suitable delivery system can be selected. Some PP of microbicide agents include physical state, organoleptic properties (color, odor, appearance, taste, etc.), molecular weight, aqueous solubility, hygroscopicity, acidity/alkalinity, permeability and absorption characteristics, stability in solid/solution state, and inherent bioadhesiveness. Thus, a well-coordinated, planned, and implemented preformulation program can help in not only accelerating microbicide formulation development, but also to minimize unforeseen failures in subsequent stages of the development. The objective of this review is to highlight the significance of PP, suggesting a systematic preformulation program.

Administration, Intravaginal↗
PubMed2001

Bioequivalence of two rimantadine tablet formulations in healthy male volunteers after single dose administration.

AIM: The bioequivalence of two rimantadine tablet formulations was determined. METHODS: The study was designed as a randomized, two-period, two-sequence, crossover study. Twenty-four healthy male volunteers received a single 100 mg dose of rimantadine hydrochloride as test (Rimantadin Lachema 100 tbl. obd., produced by Lachema, a.s., Brno, Czech Republic) and reference formulations (Elumadine 100 tbl. obd., produced by Forest Pharmaceuticals, St. Louis, USA). The two administrations were separated by 14 days and were performed in the fasting state. Blood samples were obtained at 15 time points during the interval 0-120 h after administration. Rimantadine plasma concentrations were determined by gas chromatography with electron-capture detection. RESULTS: The geometric mean concentration-time profiles of rimantadine after administration of the two formulations were superimposable. The following pharmacokinetic parameters refer to the geometric mean [exp(mean +/- SD)] values for the test and reference formulations, respectively: Cmax (ng/ml) 70.5 (60.0-82.7) vs. 70.0 (59.9 to 81.7), AUC(0-infinity) (ng x h/ml) 2872 (2224 to 3707) vs. 2849 (2195-3699), AUC(0-120 h) 2744 (2184-3448) vs. 2712 (2138-3441), t(1/2) (h) 25.8 (20.1-33.0) vs. 25.7 (20.6 to 32.1). Median (range) tmax (h) values were 4.5 (2.0-8.0) and 6.0 (2.0-8.0). Parametric 90% confidence intervals for the expected mean percentage ratios (test/reference) of the pharmacokinetic variables were within the range of 97% to 105%. The median (91.1% confidence interval) difference in tmax was -0.3 h (-2.0-0.5). The point and interval estimates were identical when truncated AUCs (0-96 h, 0-72 h, 0-48 h and 0-24 h) were used in calculations. CONCLUSION: The two rimantadine formulations were equivalent in both the rate and extent ofbioavailability and they were also well tolerated. This study confirms the findings of other studies showing that for immediate release formulations of drugs with long half-lives shortening the duration over which blood samples are collected improves the economics, is more ethical and does not impair the quality of data.

Administration, Oral↗
PubMed2000

Results of renal transplantation of the Hashemi Nejad Kidney Hospital--Tehran.

The first renal transplant in Iran was carried out in 1967. The renal transplant program severely lagged behind hemodialysis in growth until 1988. In 1988, a controlled LURD renal transplant program was adopted to provide kidneys for the large number of dialysis patients needing a renal transplant. There was no cadaveric donor transplant program. By the end of 1999, a total of 9,535 renal transplants were performed and the renal transplant waiting list of the country had been eliminated. In Iran's LURD renal transplant program, the Dialysis and Transplant Patients Association introduces the volunteer LURD to the recipient and the transplant team. There are no middlemen and no incentives for transplant teams. The government pays all of the hospital expenses for transplantation. Many poor patients are able to afford LURD transplantation and more than 50% of our LURD transplant recipients are from the poor socioeconomic class. Ethical issues within the program are under the strict observation of the transplant teams and the Iranian Society for Organ Transplantation. We have noted that many LURD transplant recipients had a potential LRD who did not donate for cultural reasons or who was reluctant to donate. In the presence of a controlled LURD renal transplant program, we feel it is more ethical to perform a paid renal transplant from volunteer LURD than a renal transplant from an LRD who may be under family pressure or coerced. The patient and graft survival rates reported from our unit are comparable to the results of renal transplants reported from centers of some other countries. Some patient deaths and graft losses could have been prevented if our transplant units were not deficient with respect to laboratory facilities and access to pharmaceutical agents. In April 2000, legislation recognizing brain death and cadaveric organ transplantation passed our parliament. Strong cultural barriers may limit the scale of cadaver donor transplantation in the coming years and we expect the programs will grow slowly. In the meantime, the LURD renal transplant program continues to serve the needs of many ESRD patients in Iran today and has allowed us to adapt this life-saving technology to our culture.

Adolescent↗
PubMed1993

Unrequested termination of life: is it permissible?

CONCLUSION: One can appreciate and understand why doctors take action to terminate life without being requested by the patient who is suffering unbearably and pointlessly. But in my opinion such action is not permissible from a moral point of view. In the first place there is a danger that interests other than those of the patient will play a decisive role. Furthermore, it is not permissible because the interest of society as a whole is at stake. The safety of all future patients would no longer be guaranteed. It is also not allowed because the medical profession must constantly be on its guard so that it does not become caught up in the situations described above. In nearly every case it should be possible for doctor and patient to discuss the termination of life explicitly and at an early stage. The ultimate reason why termination of life without request of the patient is not permissible is that in principle it will never be possible to draw a clear dividing line between unrequested and unwanted termination of life. However, it is conceivable that in certain cases the conflict of loyalties will be such that unrequested termination of life is justified. In the rare extreme case of an inescapable conflict of equally stringent duties, it may just be necessary to do something which in essence is impermissible.

Altruism↗
PubMed1993

Bioethics and culture: an African perspective.

The project of Bioethics seems to me to require paying attention to the cultural realities and assumptive frame of reference of different peoples. I assume that this must be one of the views of the organizers of this conference too and that this is why the idea of country reports is taken seriously. If I am right about this, then it makes sense for me to start my discussion with a very brief discussion of some aspects of the cultural realities of Africa with particular reference to the Yoruba of Nigeria. Then I will discuss how this world view raises issues for bioethics. Two aspects of people's worldview relevant to bioethical issues are their conception of the human person and their conception of cause. What they consider themselves to be, and what they consider to be the principles of causation will normally influence their attitudes to health and illness and their choices regarding health care. I will briefly discuss these issues with regard to the Yoruba worldview.

Africa↗