EU states back biotech patent reforms.
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Animals↗
Biomedical subjects
D Butler
Publications and source records attributed to D Butler.
Call for risk/benefit study of gene therapy.
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Advisory Committees↗
Data, data, everywhere.
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Computational Biology↗
Comparative in vitro evaluation of nimesulide-containing preparations on the Italian market.
Nimesulide is a quite popular non-steroidal anti-inflammatory drug (NSAID), which has been demonstrated to preferentially inhibit cycloxygenase-2 (COX-2), thus exerting milder gastrointestinal and renal side effects. Apart from the original products (Aulin and Mesulid), several copy and generic nimesulide-containing preparations are presently available on the Italian market. Generics are defined by the World Health Organization (WHO) as interchangeable multi-source pharmaceutical products and, according to international regulatory issues, their bioequivalence to an already marketed reference product has to be proven. Due to its physico-chemical properties, and in particular to the low solubility, nimesulide appears to be a critical molecule from a biopharmaceutical point of view. On the basis of these premises, the aim of the present work was to perform a comparative evaluation of tablets in vitro behaviour for the best-selling copy (Sulidamor) and generic (Nimesulide Dorom) in reference to the original products. The results provided by the dissolution test pointed out statistically significant differences in the in vitro behaviour displayed by the original products on one hand and by the copy as well as generic preparations in exam on the other.
Anti-Inflammatory Agents, Non-Steroidal↗
Changes in plasminogen activator inhibitor-1 levels in non-small cell lung cancer.
Increased urokinase plasminogen activator (uPA) levels are increased in a number of malignancies and have been correlated with decreased disease-free interval and decreased overall survival. We have, therefore, examined components of this plasminogen activating system in patients with Non-Small Cell Lung Cancer (NSCLC). Levels of uPA, urokinase-plasminogen activator receptor (uPAR) and plasminogen activator inhibitor-1 (PAI-1) were measured semiquantitatively in paraffin sections of tumours from 147 patients with NSCLC. Immunohistochemically stained sections of tumour were allocated a score for stain intensity and results correlated to: survival; tumour stage(T); nodal stage(N); stage grouping (I to IIIb), survival status and sex. Increased levels of PAI-1 were associated with a decreased survival in squamous cell carcinoma (SCC) X2 = 5.72, p = 0.017 (n = 74). There was a significant positive relationship between PAI-1 levels and N-stage (p = < 0.05), presence of nodal metastases (p = < 0.05), stage grouping (p = < 0.01) and extent of disease (p = < 0.05) in the total group and the SCC subgroup, but not adenocarcinoma. There was a significant positive relationship between PAI-1 levels and T-stage (p = < 0.05) in the total group, and survival status (p = < 0.05) in the SCC subgroup alone. uPA and uPAR levels were not significantly associated with tumour staging or survival. We conclude that increased PAI-1 antigen levels may be associated with a decreased survival in patients with SCC.
Actuarial Analysis↗