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At least 721 records · Page 40Linked to original sources

Using bibliometric analyses of patent literature for predicting the clinical fates of developing drugs.

Certain bibliometric features of the early literatures of developing drugs can be used to predict their ultimate clinical fates. The chronological sequence of publications is expressed as a binary vector with 1 for a patent and 0 for a nonpatent. The decimal equivalents for standardized vector lengths provide scalar values for comparing one drug with another. In order to incorporate concordant patents, fuzzy subsets are employed, with the number of attempts required to achieve transitive closure being the values for comparison. The methods involved are described using minoxidil as an example.

Bibliographies as Topic↗

More patent troubles about genes.

Two decisions by the British Appeal Court raise questions about the allowable breadth of biotechnology patents, but point to the charges patent-holders should be free to make.

Biotechnology↗

Status, sale and patenting of human genetic material: an international survey.

Following a decade of debate, the European Directive on the Legal Protection of Biotechnological Inventions was adopted by the European Parliament and the Council of the European Union on July 6, 1998. The Directive constitutes a legal and social policy landmark in biotechnology, taking an explicit position on the contentious issue of the patentability of higher life forms. It fails, however, to provide definitive statements on the legal status of human genetic material or the possibility of personal financial gain in relation to such material. An overview of the international, regional and national positions (as found in laws and official policy statements) on the status, commodification and patentability of human genetic material indicates that, although the Directive represents a consolidation of opinions, many issues remain unresolved.

Commerce↗

Population pharmacokinetics of intravenous indomethacin in neonates with symptomatic patent ductus arteriosus.

The population pharmacokinetics of intravenous indomethacin were investigated with 665 indomethacin serum concentrations from 83 neonates (mean +/- SD: gestational age, 28.8 +/- 2.5 weeks; postnatal age, 5.7 +/- 4.7 days; birth weight, 1.13 +/- 0.40 kg) receiving indomethacin for symptomatic patent ductus arteriosus. A one-compartment open model was used for pharmacokinetic analysis. Hypotheses were tested to determine which developmental and demographic data influenced clearance (CL) and volume of distribution (V(area)). In the final regression equation CL and V(area) were modeled as a function of body weight and postnatal age (PNA) from 0 to 20 days. Final estimates were as follows: CL (ml/hr) = 2.63.weight (kg) + 0.244.PNA (days) and V(area) (L) = 0.28.weight (kg) + 0.0041.PNA (days). The coefficients of variation for interindividual variability in CL and V(area) were 77% and 28%, respectively. Intraindividual variability was 19%. These mean population parameter estimates should prove useful in designing dosage regimens to achieve desired indomethacin concentrations for neonates from 0 to 20 days of age with symptomatic patent ductus arteriosus.

Birth Weight↗

Patent protection for protein structure analysis.

Three national patent offices have consulted on patents that cover protein three-dimensional structural data and pharmacophores, with significant implications for the biotechnology industry.

Biotechnology↗

The human use of humanoid beings: chimeras and patent law.

As biotechnology advances, the day may soon come for the creation of a self-aware, human-nonhuman chimera. The USPTO has ruled on whether a patent may issue on such an organism, but Congress must still legislate a dividing line between human and non-human patentable subject matter.

Animals↗

Pharmaceutical patent challenges--time for reassessment?

For nearly 15 years after the passage of the Hatch-Waxman Act in 1984, generics drug companies took little advantage of its provisions, which provided financial incentives to them for challenging the patents of branded pharmaceutical products. However, during the past 3-5 years, generics manufacturers have dramatically increased the number of patent challenges. Although these challenges can certainly benefit consumers and payers, the number of challenges puts many innovator companies at risk, which they argue is detrimental to future R&D spending. If many of the challenges are successful, then the increase in challenges could in turn be detrimental to generics, and the system itself might therefore be due for a re-balance.

Drug Industry↗

Prophylactic indomethacin reduces grades III and IV intraventricular hemorrhages when compared to early indomethacin treatment of a patent ductus arteriosus.

OBJECTIVE: To determine the relative risk of severe intraventricular hemorrhage (IVH) between two very early indomethacin treatment strategies. STUDY DESIGN: Retrospective chart review of infants <29 weeks gestation and <1350 g who received either indomethacin prophylaxis or very early echocardiography with indomethacin treatment only if the ductus arteriosus was patent. RESULTS: A total of one hundred and two infants received prophylactic indomethacin (pINDO). Echochardiography was performed on 158 infants, of whom 117 received indomethacin. Infants receiving pINDO had lower gestational age, but similar birth weight, gender, race, antenatal steroid exposure, delivery mode, Apgar scores, and need for resuscitation as infants evaluated by echocardiography. Grades III to IV IVH was observed less frequently in infants who received pINDO (OR 0.27, 95% CI 0.10 to 0.77, p=0.014). Frequency of side effects and recurrent patent ductus arteriosus did not differ between treatment groups. CONCLUSION: pINDO reduces severe IVH when compared to an early echocardiography strategy.

Cardiovascular Agents↗

Role of plasma B-type natriuretic peptide in screening for hemodynamically significant patent ductus arteriosus in preterm neonates.

BACKGROUND: B-type natriuretic peptide (BNP) is a hormone secreted by the ventricles under hemodynamic stress and congestive failure. OBJECTIVE: The objective of the present study was to evaluate whether BNP can be used as a valid screening test for the presence of a hemodynamically significant patent ductus arteriosus (hsPDA) in the preterm neonate. MATERIALS AND METHODS: This was a prospective blinded study involving preterm neonates with birth weights <or=1500 g and gestational age <or=34 weeks. Each enrolled neonate underwent the initial echocardiogram for a clinical suspicion of patent ductus arteriosus (PDA) and BNP assay within 3 hours of each other. Those neonates who did not have a PDA or who were not treated underwent a repeat echo and BNP measurement 48 to 72 hours after the first echo. In patients who received treatment for a PDA, an echo and BNP were repeated 48 to 72 hours after completion of treatment. RESULTS: A total of 29 newborns with a median birth weight of 870 g (560 to 1325 g) and a median gestation of 26 weeks (24 to 31 weeks) were enrolled at a median age of 7 days (2 to 28 days). BNP levels were significantly higher in neonates with hsPDA (n=14) compared to those without (n=15) (508.5+/-618.2 vs 59.5+/-69.9 pg/ml, p<0.005). At a cutoff value of 70 pg/ml, BNP had a sensitivity of 92.9%, specificity of 73.3%, positive likelihood ratio of 3.5 and negative likelihood ratio of 0.09 for detection of hsPDA. BNP levels dropped significantly after medical or surgical closure of hsPDA (n=12), (404.9+/-159.2 to 25.1+/-4.1 pg/ml, p=0.03). CONCLUSIONS: Elevation of plasma BNP accurately detects the presence of hsPDA in premature infants. Successful closure is reflected by a corresponding decrease in BNP. At a cutoff of 70 pg/ml, BNP is a useful screening tool for diagnosis and for monitoring efficacy of treatment of hsPDA.

Ductus Arteriosus, Patent↗

A patent lawyer's perspective.

The principles of patent law are first briefly explained. Particular patent problems which arise from the preparation of new drugs in novel chiral forms are then discussed and illustrated by reference to legal decisions.

Amoxicillin↗

Catheter closure of moderate to large sized patent ductus arteriosus using the simultaneous double or triple coil technique.

BACKGROUND: Although the clinical experience with transcatheter closure of the patent ductus arteriosus using the coils has grown rapidly, one important complication of this procedure using the conventional Gianturco coil was the migration of coils into peripheral vessels. This is especially for patients with a relatively larger size ductus and the risk for such complications could be increased. In this situation, the detachable coil may have some technical benefits to perform coil occlusion and reduce the incidence of complications. METHODS: We describe the clinical efficacy of a simultaneous double or triple coil occlusion technique using the Cook detachable coil or bioptome delivered 0.052 inch Gianturco coil to close the ductus arteriosus. This was performed in patients whose ductus diameter was greater than 3.0 mm. RESULTS: From February 1995 to December 2000, 118 patients with patent ductus arteriosus were treated by coil occlusion using Cook detachable coils, of whom 58 patients whose minimum diameter of ductus > or = 3.0 mm were reviewed. All patients had successful placement of coils. According to the evaluation by color flow mapping, a trivial shunt was observed in 17 patients (29%) within 24 h after the procedure. In 11 out of 17 patients, a residual shunt was not detected 1 month after the procedure. At 6 months after the procedure, the residual shunt was detected only in three patients. CONCLUSIONS: Although this study did not calculate the statistical significance between detachable and non-detachable coils in term of occlusion rate, our institutional experience suggests that the simultaneous double or triple coil technique using the detachable or 0.052 inch Gianturco coils can reduce the prevalence of coil migration or complications.

Adolescent↗

Safety of a patented special butterbur root extract for migraine prevention.

OBJECTIVE: To report on the safety of a patented special butterbur root extract used for migraine prevention. BACKGROUND: Two placebo-controlled clinical trials have been conducted supporting the beneficial use in humans. METHODS: Results from acute, subchronic and chronic animal toxicity studies as well as from mutagenicity studies are reported. Safety data gained from clinical trials, postmarketing surveillance studies and pharmacovigilance are evaluated and discussed. CONCLUSION: The patented special butterbur root extract is safe for the treatment in humans.

Adolescent↗

Esophageal obstruction caused by a left aortic arch and an anomalous right patent ductus arteriosus in two German Shepherd littermates.

OBJECTIVE: To present details of surgical management of an unusual vascular ring anomaly in two German Shepherd littermates. STUDY DESIGN: Clinical case report. STUDY POPULATION: Three-month-old intact male and female German Shepherd littermates. RESULTS: In each dog, the esophagus was obstructed by a vascular ring comprised of the left aortic arch, an anomalous patent right ductus arteriosus, and the pulmonary artery ventrally. Surgical treatment consisted of dividing and oversewing the patent right ductus arteriosus. Neither dog has clinical signs of esophageal disease one year after treatment. CONCLUSION AND CLINICAL RELEVANCE: This vascular ring anomaly should be considered a possibility in any young dog with esophageal obstruction and a machinery murmur.

Animals↗

Ligation of the patent ductus arteriosus in premature infants--indications and procedures.

Premature newborns with patent ductus arteriosus can be managed by prostaglandin inhibition, but this medical treatment carries a high risk of renal failure, and other complications such as necrotizing enterocolitis and hematologic disorders have been described. Echocardiography gives an early confirmation of shunt and surgical treatment may be proposed. The aortic arch anatomy in the premature infant may not be as simple to determine as the anatomy of an older child. In the premature infant the use of a clip for patent ductus arterious closure seems the best technique, avoiding circular dissection of the ductus. We report our experience of 68 cases operated upon.

Cause of Death↗

The value of contrast echocardiography in the diagnosis of patent ductus arteriosus with Eisenmenger's syndrome.

When patent ductus arteriosus (PDA) is complicated by pulmonary hypertension resulting in a right-to-left shunt, an erroneous diagnosis of primary pulmonary hypertension may be made, even after echocardiographic examination. Among the 8 patients referred to our echocardiography laboratory with the diagnosis of primary pulmonary hypertension between June 1994 and November 1999, 2 patients were found to have PDA with Eisenmenger's syndrome. Patent ductus arteriosus with Eisenmenger's syndrome can be diagnosed by the opacification of the abdominal aorta without opacification of the left-sided chambers during contrast echocardiography.

Adolescent↗