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At least 451 records · Page 25Linked to original sources
PubMed2005

Pharmaceutical analysis beyond compendial requirements.

Recent ICH recommendations on test procedures and acceptance criteria for new drug substances of synthetic chemical origin and new drug products produced from them (Q6A) sets the frame for registration of new chemical entities. These requirements are automatically applied by all pharmaceutical companies to products in late developmental phases. Furthermore, and justifiably so, they do not provide any guideline for setting specifications other than those for residual solvents and residues of heavy metal catalysts. During development of new chemical entities, ICH requirements represent a minimum beyond which additional testing has to be carried out in order to accumulate a body of scientific data which may ultimately permit simplified testing. This information is furthermore needed for drafting of registration files. This presentation will provide information on salt and polymorph selection, as well as morphology of particles. The need for more sophisticated techniques for assay of trace impurities by LC/MS will be illustrated with examples of alkylating agents. Complementary information from techniques such as CE, orthogonal to HPLC, is often needed to ensure absence of additional impurities. Finally, beyond compendial characterisation of hydroxypropylmethylcellulose, a commonly used excipient, by size exclusion chromatography with triple detection will be described.

Chromatography, High Pressure Liquid↗
PubMed1984

Myofacial pain dysfunction syndrome: a clinical study of asymptomatic subjects.

The diagnosis of myofacial pain dysfunction (MPD), commonly called temporomandibular joint syndrome, has traditionally been made on the presence of a group of clinical symptoms that produce pain and limitation of movement. The cause of this common illness has been the subject of controversy for over half a century. There has been a lack of agreement on diagnosis, a cause, and treatment. Advanced bioelectronic technology now makes an accurate diagnosis possible, based not merely on clinical symptoms, but on reproducible scientific data. A cause of MPD is discernable and reliable treatment possible, as well as long lasting resolution objectively monitorable with the Mandibular Kinesiograph (MKG 5-R) and Bioelectric Processor (EMIR). A study of mandibular movement and masticular muscle function of 26 "normal" subjects (i.e., clinically asymptomatic) revealed that the overwhelming majority did indeed have dysfunction of the muscles which move and posture the mandible. The significance of this study is twofold. First it demonstrates a valid testing procedure for measuring mandibular movement and muscle function. Second it establishes the fact that most individuals have a physical predisposition to MPD. Changes in the adaptive capacity of the neuromusculature by physical or emotional trauma could then precipitate MPD.

Adult↗
PubMed2004

Whiplash: pathophysiology, diagnosis, treatment, and prognosis.

We have reviewed the literature relevant to pathophysiology, diagnosis, treatment, and prognosis of whiplash-associated disorder (WAD) since 1995 and provided a brief summary of literature pertaining to forces action on the head and neck during a motor vehicle accident. The scope of the current review is confined to the Quebec guidelines for WAD grades 1-3 but excludes grade 4 (neck complaints and fracture or dislocation). After excluding papers without scientific data and single case reports or case series with fewer than 20 patients, articles were reviewed for methodological quality. The diagnosis remains clinical. No imaging, physiological, or psychological study provides specific diagnostic criteria. In the acute period up to 2 weeks, soft collars or rest and work-leave do not shorten the duration of neck pain. Sick leave is reduced by high-dose methylprednisolone given within 8 h of injury, but confirmatory studies examining the cost-benefit relationship are needed. In the first 6 months, active as opposed to passive treatment results in improved outcomes. Specific exercise strategies have not been studied. For those with symptoms lasting more than 6 months, percutaneous radio-frequency neurotomy can provide pain relief for many months in those responding to blind local anesthetic facet blocks. Intra-articular corticosteroids are ineffective. Uncontrolled trials suggest that multimodal rehabilitation programs result in improved overall function. The overall prognosis for recovery has varied considerably across studies. Such variability is likely due to differences in case identification methods and whether outcome is assessed in terms of symptoms or the receipt of financial compensation for injury. The impact on prognosis of both collision- and patient-related factors is also reviewed.

Humans↗
PubMed1995

Some reflections on establishing a community legislation on mycotoxins.

A Community legislation on mycotoxins is essential to protect public health and to avoid trade barriers and competition distortions. Maximum permitted levels in food are to be fixed. Some orientations for this purpose are indicated. The verification of the compliance with maximum permitted levels shall need suitable analytical methods. Up to now, such methods were fixed by directives. This approach, however, had some disadvantages. A more flexible approach is to be planned. Among the mycotoxins to be taken into consideration, priority should be granted to the aflatoxins and to ochratoxin A. Fumonisins also deserve interest. Other mycotoxins will be taken into consideration as the need arises and scientific data are available. Some basic remarks on the rationale for establishing maximum permitted levels in food are made.

Food Analysis↗
PubMed2003

Power and sample size calculations for generalized regression models with covariate measurement error.

Covariate measurement error is often a feature of scientific data used for regression modelling. The consequences of such errors include a loss of power of tests of significance for the regression parameters corresponding to the true covariates. Power and sample size calculations that ignore covariate measurement error tend to overestimate power and underestimate the actual sample size required to achieve a desired power. In this paper we derive a novel measurement error corrected power function for generalized linear models using a generalized score test based on quasi-likelihood methods. Our power function is flexible in that it is adaptable to designs with a discrete or continuous scalar covariate (exposure) that can be measured with or without error, allows for additional confounding variables and applies to a broad class of generalized regression and measurement error models. A program is described that provides sample size or power for a continuous exposure with a normal measurement error model and a single normal confounder variable in logistic regression. We demonstrate the improved properties of our power calculations with simulations and numerical studies. An example is given from an ongoing study of cancer and exposure to arsenic as measured by toenail concentrations and tap water samples.

Arsenic↗
PubMed1989

Treatment of localized prostatic cancer.

Discovery of a localized prostatic cancer frequently creates a therapeutic dilemma. A significant number of patients do well for an extended period of time without treatment, while others suffer rapid tumor progression and death from prostatic cancer. Without treatment nearly one third of patients with stage B prostatic cancer can be expected to develop distant metastatic disease or death from prostatic cancer within 10 years. In patients who otherwise have a reasonable life expectancy of 10 years or more, aggressive therapy is justified. Long-term disease-free survival has been reported after both radical prostatectomy and external irradiation. The fact that nearly 50% of patients treated with external irradiation for stage B prostatic cancer have positive postirradiation biopsies is of concern, but the impact of this finding on overall survival is yet to be determined. The only randomized prospective study comparing radical prostatectomy with external irradiation showed a statistically significant decrease in the time to Nevertheless, as evidenced by the National Institutes of Health Consensus Development Panel, further randomized prospective trials are needed to determine the relative value of radical prostatectomy versus external irradiation for localized prostatic cancer. For the forseeable future, definitive scientific data on which to base treatment recommendations will not be available. Therefore, patients should be well informed of the various treatment options available, and the wishes of the patient are paramount. The clinician's roles are to interpret the data, present it in a meaningful manner to patients, be guided in discussions by patient preferences, and make recommendations.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗
PubMedDate not supplied

Technical considerations in the surgical treatment of colon and rectal cancer.

Surgery is the primary mode of therapy for colorectal cancer. Advances beyond exteriorization began to appear at the end of the nineteenth century. The antibiotic era brought on more advances. Dogma abounds with respect to the technical aspects of surgery for colon and rectal cancer and few randomized, prospective trials have been done to evaluate the importance of these techniques. Firmly established are the techniques of resection of lymphatic drainage of tumors, en bloc resection of invaded structures, and obtaining at least 2 cm margins of rectal cancers. Radical lymph node dissection, luminal ligation, oophorectomy, and the "No-Touch Technique" are discussed. Despite the paucity of irrefutable scientific data to support many of the described surgical techniques, differences in outcome between surgeons suggest that technique is important. There is great need for randomized, prospective trials to evaluate the multitude of techniques described for the surgical treatment of colorectal cancer.

Colectomy↗
PubMed1981

The teratogenic effects of dietary Cassava on the pregnant albino rat: a preliminary report.

Cassava is a tuberous root of a shrublike plant cultivated in tropical rain forests as a staple food in South Eastern Nigeria. Reports are on record showing correlation between cassava intake and occurrence of various types of neuropathies (Money, '59; Monekosso and Wilson, '66; Osuntokun et al., '68,'69). About 0.1-2 mg of cyanide/100 gm is released from Cassava by action of hydrolase (Paula and Rangel, '46). It has been suspected by several local clinicians as a cause of congenital anomalies if consumed in excess during pregnancy. However, it remains a controversial problem and precise scientific data is lacking. This study was conducted on albino rats by giving them milled cassava powder as 50% and 80% of their diet during the first 5 days of pregnancy. Fetuses collected on day 20 from the group receiving cassava as 80% of the diet showed a low incidence of limb defects, open eye, microcephaly, and growth retardation in the rat. Interpretation of this data for the human should be made with caution.

Abnormalities, Drug-Induced↗
PubMed1993

Predictive strategies for selecting 379 NCI/NTP chemicals evaluated for carcinogenic potential: scientific and public health impact.

The a priori criteria used by the National Cancer Institute/National Toxicology Program (NCI/NTP) are described for 379 chemicals selected and evaluated for carcinogenic potential. We classified the chemicals according to exposure and structural categories and evaluated the predictive ability of the scientific selection criteria of chemicals suspected of being carcinogenic in advance of any study. Of the 379 chemicals, 253 (67%) were selected with a suspicion of carcinogenicity; 171 (68%) of these 253 chemicals induced cancer in at least one of the sex-species experiments. The other 126 (33%) chemicals were selected mainly, but not exclusively, on the basis of exposure considerations and production volumes; only 27 (21%) of these were judged to be positive. Overall, 198 (52%) of the 379 chemicals studied induced tumors in at least one organ of one sex of one species, but only 87 (23%) of these 379 chemicals were positive in both species and are considered most likely to present carcinogenic hazards to humans. Importantly, 78 (90%) of these 87 chemicals were selected with a prospective suspicion of carcinogenicity. Although the program has studied only a part of the "Universe of Chemicals" (defined as chemicals to which humans are exposed), the scientific data generated are essential for developing structure activity data bases of potentially hazardous chemical classes and for predicting the carcinogenicity of chemicals not yet studied. Thus, the bioassay program has had beneficial and crucial impacts on public health, as demonstrated by the use of these data by international, Federal, and State regulatory agencies to reduce or eliminate exposures to chemicals shown to be unequivocally carcinogenic in laboratory animals.

Animals↗
PubMed1996

Intracellular transducing mechanisms coupled to brain somatostatin receptors.

This review systematically analyses recent knowledge of the biology of somatostatin receptors. Indeed, since the molecular cloning of five somatostatin receptors in 1992, a growing bulk of scientific data has been produced regarding the cell type localization, the physiological role and the biochemical intracellular pathways activated by the single somatostatin receptors. The aim of this review is to present all these data, also discussing the conflicting evidence that has been reported, to further simulate research efforts in the field.

Animals↗
PubMed2002

Simulation of the exposure to deoxynivalenol of French consumers of organic and conventional foodstuffs.

The aim of this study was to estimate the exposure to deoxynivalenol in wheat of consumers of organic and conventional products using a probabilistic method, and to compare these levels with a toxicological reference so as to provide risk managers with scientific data to be used in the regulatory decision-making process. First, a product consumption frequency questionnaire was completed by consumers of organic products, thus providing data on the consumption of organic products. Data on the consumption of conventional products were obtained from the French "INCA" survey. Data on deoxynivalenol levels in wheat came from a previous study. The results of exposure simulations using the Monte-Carlo sampling method showed that 10% of those consuming organic wheat containing deoxynivalenol may be exposed to this natural toxin at levels above the provisional maximum tolerable daily intake.

Computer Simulation↗
PubMed2004

Clinical quality standards for gamma knife radiosurgery--the Munich protocol.

The clinical quality standards for outpatient gamma knife radiosurgery as developed in the German Gamma Knife Center Munich during the last ten years are described. The following aspects have been taken into account: appropriate patient selection, standardised treatment cycle, acquisition of high-quality stereotactic MR images, the integrated therapeutic concept, dose conformity and dose level, patient follow-up, quality control and scientific data analysis. Particular emphasis has been put on the importance of the interdisciplinary treatment concept by subspecialised experts. The results of the Munich concept in consideration of the described quality standards verifies that gamma knife radiosurgery is a safe and effective treatment option for well selected indications.

Ambulatory Surgical Procedures↗
PubMed1988

Ethics of functional neurosurgery.

With the precision and accuracy available for modern techniques, operations on the brain for alleviating psychiatric disorders have become safer and reliable. Anxiety and feelings of doubt amongst the public about these procedures need to be dispelled. There is a need to compile accurate clinical and scientific data with careful follow up to assess the present status of functional neurosurgery and to ensure further progress.

Ethics, Medical↗
PubMed1990

Premenstrual syndrome as a criminal defense.

Premenstrual syndrome may be effective as an affirmative defense to a criminal charge if the defendant can show that (i) she was suffering from premenstrual syndrome at the time the crime was committed; and (ii) because of her condition, either that the criminal act was an involuntary act or that at the time of the criminal act she did not possess the mental state required by law for the commission of a crime. Premenstrual syndrome has been successfully pleaded as a criminal defense in Great Britain but has not been tested in American criminal courts. It may now be possible, however, because of the increase of behavioral, psychological, and physiological studies precisely characterizing premenstrual syndrome and elucidating the necessary criteria for its accurate diagnosis, for the appropriate defendant to assert this defense in an American court. This paper discusses (i) the use of recent scientific data to demonstrate the existence of premenstrual syndrome; (ii) the use of standardized psychological tests or physiological assays to demonstrate that the defendant suffers from premenstrual syndrome; and, (iii) the legal choices to be made and evidentiary hurdles that must be overcome in presenting a premenstrual syndrome defense.

Crime↗
PubMedDate not supplied

Optimum needle length for DPT inoculation of Indian infants.

Correct placement of the injected DPT vaccine into the deep muscular layers decreases the local reactions, including the sterile abscess formation. However, recommendations on size of the needle to be used and the angle of injection are not easily available, are not uniform and are based on case reports. The only study based on scientific data of ultrasonographic measurement of fat layer and muscle layer thickness of thigh of only 24 infants of 4 months age covers only American children. (Hick et al, Pediatrics 1989; 84: 136-37). In the present study, we have produced similar data on 215 Indian children belonging to all those age groups in which DPT vaccinations are given. Mean thickness of skin + fat layer in the middle one-third of the anterolateral aspect of thigh was 1.03 +/- 0.23 cm, 1.04 +/- 0.21 cm, 0.95 +/- 0.19 cm and 1.06 +/- 0.27 cm in the age groups of 6-12 weeks (Groups I), 13-18 weeks (Group II), 19-24 weeks (Groups III) and 18 +/- 1 month (Group IV) respectively. These age groups correspond to the timings of first 3 primary doses and the first booster dose of the DPT vaccine in our immunization clinic. Mean thickness of all the soft tissues together at the same site were 1.87 +/- 0.35, 2.17 +/- 0.38, 2.07 +/- 0.39 and 2.07 +/- 0.26 cm respectively for the groups I to IV.(ABSTRACT TRUNCATED AT 250 WORDS)

Developing Countries↗
PubMed2006

[Problems and chances of the application of systemically acting drugs via the lung].

As a consequence of the development of drugs and other biologically active substances such as peptides or proteins, new ways of application for therapeutic use offer new therapeutic possibilities. Today, the predominant way of parenteral application is injection. Growing evidence suggests that some substances may be applied via inhalation. Nevertheless, inhalative application of drugs, although possible, is not very well supported by scientific data until now. This paper summarizes the present knowledge about transport of higher-molecular drugs across the pulmonary epithelium and deals with the problems of this method of application as well.

Administration, Inhalation↗
PubMed2006

[High need for improvement and many open questions in health care for palliative patients].

The health care for patients with incurable, advanced diseases is increasingly attended to in Germany. Among other things, this is enforced by the debate on euthanasia and by the criticism of the inadequate structure of services and processes of care. The palliative care approach refers to cancer as well as to non-cancer patients; due to demographic changes, it becomes more and more important for an increasing number of old and very old patients with particular complex needs (e. g., caused by multimorbidity, dementia and chronic pain). Therefore, the need for improving palliative care is immense. However, the statements on the current situation and the recommendations for improvement are based only slightly on valid scientific data. This article (written from the perspective of health services research) provides an overview on the topic with particular respect to the structure of specialized palliative care services (such as palliative care teams and palliative care units) and to the political framework. Open questions on diverse levels are picked out as a central theme, and the need for interdisciplinary, application-oriented research is pointed out.

Forecasting↗
PubMed2000

[Reasonable and unreasonable hygiene measures in anesthesia in the intensive care unit].

The objective of this review is to describe which hygiene measures are appropriate and necessary in anaesthesia and the ICU and which are not, whereby unnecessary hygiene measures are those which are not substantiated by scientific data. The most effective single infection control measure is still hand disinfection between patient contacts. Unnecessary measures include routine sampling of environmental surfaces, disinfecting the floor in the ICU, protective gowns for visitors, so called in-line filters in the infusion system etc. Ventilator tubes only need to be exchanged once a week, even when no HMEs are used.

Anesthesia↗