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PubMed2005

Biowaiver monographs for immediate release solid oral dosage forms: ranitidine hydrochloride.

Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the approval of immediate release (IR) solid oral dosage forms containing ranitidine hydrochloride are reviewed. According to the current Biopharmaceutics Classification System (BCS), ranitidine hydrochloride should be assigned to Class III. However, based on its therapeutic and therapeutic index, pharmacokinetic properties and data related to the possibility of excipient interactions, a biowaiver can be recommended for IR solid oral dosage forms that are rapidly dissolving and contain only those excipients as reported in this study.

Administration, Oral↗
PubMed2005

Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.

Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. Also in view of its therapeutic use, its wide therapeutic index and uncomplicated pharmacokinetic properties, a biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts, the dosage form is rapidly dissolving (85% in 30 min or less) in buffer pH 6.8 and the test product also exhibits similar dissolution profiles to the reference product in buffer pH 1.2, 4.5, and 6.8.

Administration, Oral↗
PubMed2005

Usefulness of electrodiagnostic techniques in the evaluation of suspected tarsal tunnel syndrome: an evidence-based review.

This evidence-based review was performed to evaluate the utility of nerve conduction studies (NCSs) and needle electromyography (EMG) in the diagnosis of tibial neuropathy at the ankle (tarsal tunnel syndrome, TTS). A total of 317 articles on TTS were identified that were published in English from 1965 through April 2002, from the National Library of Medicine MEDLINE database. All articles were reviewed on the basis of six selection criteria. The results of this search revealed that four articles met five or more criteria. All four articles examined the use of electrodiagnostic (EDX) techniques for the evaluation of patients with clinically suspected TTS, and were included in this practice parameter. Each of these four studies was considered to meet Class III level of evidence. NCSs were abnormal in some patients with suspected TTS. Sensory NCSs were more likely to be abnormal than motor NCSs but the actual sensitivity and specificity could not be determined. The sensitivity of needle EMG abnormalities could not be determined. NCSs may be useful for confirming the diagnosis of tibial neuropathy at the ankle, recommendation Level C. Well-designed studies are needed to evaluate more definitively EDX techniques in TTS.

Action Potentials↗
PubMed2006

Systematic review and meta-analysis of methods of diagnostic assessment for urinary incontinence.

AIMS: To evaluate the performance of all tests proposed for the diagnosis of urinary incontinence. METHODS: A systematic review and meta-analyses of the published literature of methods for diagnostic assessment of urinary incontinence. RESULTS: One hundred twenty-one papers were included in the full review [Martin et al., 2006]. The quality of reporting in the primary studies was poor which reduced the number of studies that could be included in the data analysis. The literature suggests that women with urodynamic stress incontinence (USI) can be correctly identified in primary care from clinical history alone with a sensitivity of 0.92 (95% C.I.: 0.91-0.93) and specificity of 0.56 (0.53-0.60). A clinical history for the diagnosis of detrusor overactivity (DO) was found to be 0.61 (0.57-0.65) sensitive and 0.87 (0.85-0.89) specific. Within secondary care imaging of leakage by ultrasound was found to be effective in the diagnosis of USI in women with a sensitivity of 0.89 (0.84-0.93) and specificity of 0.82 (0.73-0.89). CONCLUSIONS: Clinical interpretation of the results of the review is difficult because few studies could be synthesized and conclusions made. The published evidence suggests that a large proportion of women with USI can be correctly identified in primary care from history alone. Ultrasound offers a useful diagnostic tool which could be used prior to, and possibly instead of, multi-channel urodynamics in some circumstances. If a patient is to undergo urodynamic testing, multi-channel urodynamics is likely to give the most accurate result. Further primary studies adhering to STARD guidelines are required on commonly used tests.

Data Interpretation, Statistical↗
PubMed2003

Adverse events in acute care: an integrative literature review.

An integrative literature review was conducted to investigate studies on adverse events reported in medical, health services, and nursing literature. The review was guided by the method proposed by Jackson (1980) and Ganong (1987). Three questions shaped the review: (a) What terms are used to denote adverse events? (b) What purposes drive adverse events research? and (c) What data sources are used to study adverse events? Adverse events was the dominant term, the study of adverse events as an outcome variable was the prevailing research purpose, and monitoring or screening the patient clinical record and self-reported incidents by health care professionals were the main data sources. Future research is recommended to conceptualize and study adverse events.

Acute Disease↗
PubMed2005

SPS' Digest: the Swiss Proteomics Society selection of proteomics articles.

Despite the consolidation of the specialized proteomics literature around a few established journals, such as Proteomics, Molecular and Cellular Proteomics, and the Journal of Proteome Research, a lot of information is still spread in many different publications from different fields, such as analytical sciences, MS, bioinformatics, etc. The purpose of SPS' Digest is to gather a selection of proteomics articles, to categorize them, and to make the list available on a periodic basis through a web page and email alerts.

Animals↗
PubMed1992

Stereochemical quality of protein structure coordinates.

Methods have been developed to assess the stereochemical quality of any protein structure both globally and locally using various criteria. Several parameters can be derived from the coordinates of a given structure. Global parameters include the distribution of phi, psi and chi 1 torsion angles, and hydrogen bond energies. There are clear correlations between these parameters and resolution; as the resolution improves, the distribution of the parameters becomes more clustered. These features show a broad distribution about ideal values derived from high-resolution structures. Some structures have tightly clustered distributions even at relatively low resolutions, while others show abnormal scatter though the data go to high resolution. Additional indicators of local irregularity include proline phi angles, peptide bond planarities, disulfide bond lengths, and their chi 3 torsion angles. These stereochemical parameters have been used to generate measures of stereochemical quality which provide a simple guide as to the reliability of a structure, in addition to the most important measures, resolution and R-factor. The parameters used in this evaluation are not novel, and are easily calculated from structure coordinates. A program suite is currently being developed which will quickly check a given structure, highlighting unusual stereochemistry and possible errors.

Databases, Bibliographic↗
PubMed1995

Practical methodology of meta-analyses (overviews) using updated individual patient data. Cochrane Working Group.

Meta-analyses using updated individual patient data may provide the most reliable means of combining data from similar randomized controlled trials. The benefits of this approach to systematic reviews are described. Guidance, based on the experience of several groups who have undertaken such projects, is given. This includes practical advice on initiating and maintaining collaboration, the time and resources required to undertake these usually international projects and methods of data checking and validation. Example proforma are included.

Data Collection↗
PubMed1992

Pharmacologic validation of human tumor clonogenic assays based on pleiotropic drug resistance: implications for individualized chemotherapy and new drug screening programs.

Because of the bias toward successful cloning of human tumor cells from more advanced malignancies, alternative approaches to clinical correlations of drug resistance are needed to determine the validity of the human tumor clonogenic assay (HTCA) as a clinically useful test. Capitalizing on the prevalence of clinical drug resistance among these advanced malignancies, we have taken an independent approach to testing the validity of HTCAs based upon pharmacologic principles rather than tumor response. A database of results from drug sensitivity/resistance testing in 1,777 HTCAs has been examined retrospectively for specimens exhibiting either the MDR1 or Topo-II pleiotropic drug resistance phenotype. Twenty specimens were identified as MDR1 based upon test results showing resistance to adriamycin, vinca alkaloid, and etoposide. Test results with mitomycin-c confirmed the MDR1 phenotype in eight out of nine of these specimens. Seven out of eight of the confirmed MDR1 samples were resistant to either cis-platinum or alkylating agents or to both. There was no significant difference in the 5-fluorouracil resistance of these MDR1 specimens and the database as a whole, demonstrating the specific nature of this drug resistance phenotype in vitro. One specimen, a squamous carcinoma of the lung, was mitomycin-c sensitive, even though it exhibited all the other drug resistances characteristic of the MDR1 phenotype. Six specimens with the Topo-II phenotype were identified based upon resistance to adriamycin and etoposide with sensitivity to vinca alkaloids. Surprisingly, the Topo-II phenotype showed a strong association with increased cis-platinum resistance and a weaker one with decreased 5-fluorouracil resistance. Thus, 26/30 (87%) of analyzable specimens showed some form of clinically characterized multidrug resistance, illustrating how easily one can obtain 90% accuracy in predicting clinical drug resistance with HTCAs that are heavily biased by a disproportionate number of successful cloning assays with advanced malignancies. The data analysis also shows that prediction of adriamycin resistance based on lack of Topoisomerase II expression will not be very accurate, in contrast to a previous claim. Until cell culture technology can facilitate frequent successes in the cloning of early detected, drug-sensitive lesions, this bias will remain in HTCA databases, and studies comparing HTCA results with clinical response will continue to be uninformative. However, the in vitro identification of pleiotropic drug resistance phenotypes exactly analogous to those previously observed in patients provides pharmacologic validation at least for the prediction of drug resistance as measured by current HTCAs using suprapharmacologic drug concentrations.

Antineoplastic Agents↗
PubMed1996

EMBASE remains EMBASE--on every host? A comparative analysis of EMBASE on the hosts DATA-STAR, DIALOG, DIMDI, and STN.

Differing results of the same search request processed on different hosts led the authors to investigate this issue more thoroughly. Two authors, two journal titles, two drug names, and two topics of a general medical nature were retrieved under identical circumstances and conditions on the hosts DATA-STAR, DIALOG, DIMDI, and STN. Comparing the figures revealed that none of the nine search request produced an identical result on all hosts. Some of the search results differed only slightly, while the searches in the basic index produced considerable discrepancies.

Databases, Bibliographic↗
PubMed1993

Database programs as a literature research tool for the 1990s scientist: surveillance of neurotoxicology data.

As the mass of data and literature in any scientific field grows, it becomes increasingly difficult to recall details of early experiments and to relate findings in different studies. Simple database programs are available for the individual scientist to record and manipulate information, to provide a reliable and flexibly updatable memory aid, and to reveal new relationships through (re)organizations of information. Such programs can increase the efficiency of the literature research process and increase writing productivity by orders of magnitude. The use of database programs for literature research is exemplified with a behavioral neurotoxicology database revealing previously unappreciated consistencies in the human worksite research literature.

Databases, Bibliographic↗
PubMed1997

Acrylonitrile: a reevaluation of the database to support an inhalation cancer risk assessment.

Acrylonitrile (ACN) is a monomer used extensively in the production of plastics, synthetic fibers, and rubber. In previous assessments conducted by IARC and the EPA, ACN was classified as a probable human carcinogen based on limited evidence in humans and sufficient evidence in laboratory animals. Specifically, EPA had determined that there was an association between ACN exposure and lung cancer based on a study by O'Berg (1980, J. Occup. Med. 22, 245-252). However, a follow-up of this cohort (O'Berg et al., 1985, J. Occup. Med. 27, 835-840) shows no statistically significant excess of lung cancer mortality or incidence. Our evaluation of the more recent human database taken as a whole shows that there is not a clear association between ACN exposure and human cancer, yet the studies have insufficient power to be able to rule out a small increase. In laboratory rats, however, ACN has been shown to be clearly carcinogenic by the oral and inhalation routes. Applying the methodology of EPA's proposed 1996 cancer risk assessment guidelines to the rat tumor data, the estimated upper bound on the excess lifetime risk at continuous exposure to 1 microgram/m3 ACN is calculated to be in the range of 8.2 x 10(-6) to 1.1 x 10(-5).

Acrylonitrile↗
PubMed1990

Molecular and genetic characterization of two pollen-expressed genes that have sequence similarity to pectate lyases of the plant pathogen Erwinia.

A set of cDNAs that are expressed in tomato anthers were isolated. We further characterized two of these cDNAs (LAT56 and LAT59) and their corresponding genomic clones. LAT56 and LAT59 show low levels of steady-state mRNA in immature anthers and maximal levels in mature anthers and pollen. The LAT56 and LAT59 genes are single-copy in the tomato genome, and are linked on chromosome 3, approximately 5 cM apart. Although these cDNAs did not cross-hybridize, their deduced protein sequences (P56 and P59) have 54% amino acid identity. The LAT56 and LAT59 genes each have two introns, but they are located in non-homologous positions. P56 and P59 show significant protein sequence similarity to pectate lyases of plant pathogenic bacteria. The similarity of P56 and P59 to the bacterial pectate lyases is equivalent to the homology described for different pectate lyase sequences of the genus Erwinia. We suggest that the pollen expression of LAT56 and LAT59 might relate to a requirement for pectin degradation during pollen tube growth.

Amino Acid Sequence↗