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Curve in Medical Technology

Researchers at Axial Biotech Develop a DNA Test for Scoliosis

... of a DNA-based prognostic test for spinal curve progression in patients with Adolescent ... Adolescent Idiopathic Scoliosis (AIS). If an AIS curve progresses, the most widely accepted treatments ... the genetic markers associated with spinal curve progression," stated Ken Ward, M.D., Chief ...

Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously

... or subcutaneously at an adapted dose, as measured by the area under the curve of IgG concentration vs. time curve per week. Final results of the study are expected to become available in ...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

... levels reached the highest points (known as Cmax), lowest points (known as Cmin) as well as overall edoxaban exposure (measured by area under the curve or AUC). Delivering a compound twice per day generally allows for more consistent concentration levels in the blood. With twice-daily dosing, the ...

ADVENTRX Announces Results From ANX-514 Bioequivalence Study

... provide sufficient data to support an NDA. Pharmacokinetic equivalence was assessed by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax) and determined based on federal regulations and FDA guidance regarding bioequivalence studies. If the ...

Oakwood Surgeons Perform World's First 3D Surgery Without Special Glasses

... " with this device ... I expect that teaching medical students and interns how to perform endoscopic procedures will be much easier; the learning curve should definitely be shorter." The first public showing of LifeVision(TM) will take place at the annual meeting of The Society of American ...

NewCardio Leadership to Present Two Abstracts at ISCE Conference

... may lead to unexpected distortions in key parameters that affect drug safety assessment. "End of T Wave Determination by Polynomial curve Fitting on a Vector Magnitude Lead," authored by Drs. Bosko Bojovic, Ljupco Hadzievski, Ihor Gussak, Samuel George and Branislav Vajdic. This ...

Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders

... outcome measures included pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy as measured by time-normalized area under the curve (TNAUC) for ammonia. Patients were enrolled on their stable dose of BUPHENYL and 24-hour PK, ammonia measurements, amino acids, and urine ...

Genaera Presents Preliminary Phase 1b Data for Trodusquemine (MSI-1436)

... fasting blood glucose with a resulting 17% differential compared to placebo subjects in the same cohort; A 7% decrease in the area under the curve during the oral glucose tolerance test; An 11.3% decrease in serum fructosamine, which is used to monitor short-term (2-3 weeks) blood sugar ...

Society of Gynecologic Oncologists 40th Annual Meeting on Women's Cancer to Include Sessions on Robotics Surgery

... outcomes within the field along with a special surgical post-graduate (SPG) course that will provide "tips and tricks" to help shorten the learning curve with robotics. "Gynecologic oncologists are becoming more and more interested in robotic technology for the treatment of gynecologic ...

Head-to-Head Study Demonstrates Focalin(R) XR Offers Faster and Better Symptom Control than Concerta(R)1 in Early Part of ADHD Patients' Day

... of the differences in release profiles, the investigators also studied overall efficacy during the 12 hour study period using an area under the curve analysis (AUC0-12) of the SKAMP combined scores. All doses of the active medication were significantly better than placebo. There was no difference ...

Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

... Humalog (p = 0.0003) and 142% for Humulin R (p 0.0001). -- The increase in systemic insulin exposure, expressed as the mean area under the curve (AUC) was significant over the first 30 minutes, when insulin release drives meal ingestion metabolism: 277% for Humalog (p = 0.0008) and ...

Concomitant Treatment With Nebulized Formoterol Fumarate and Tiotropium Provides Clinically Significant Improvements for COPD Patients

... (FFIS; Perforomist(TM), 20mcg/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV(1) over three hours (FEV(1) AUC(0-3)) at the last visit (week 6). The standardized absolute AUC(0-3) for FEV(1) following the first dose of ...

Data Show FLECTOR(R) Patch Yields Significant Pain Reduction for Acute Strains, Sprains and Contusions

... (steady state) was 1.7 plus or minus 0.9ng/mL versus Voltaren(R) (single dose), 1214 plus or minus 750ng/mL. Area under the plasma concentration curve (AUC) for zero to 12 hours was FLECTOR(R) Patch at 15.2 plus or minus 6.9ng*h/mL versus Voltaren(R), 1754 plus or minus 1060 ng*h/mL. The ...

Pharmacokinetic Data Suggest NGX426, TorreyPines Therapeutics' Oral Prodrug of Tezampanel, May be Effective in Treating Acute Migraine Headache

... data obtained in a Phase I maximum tolerated dose clinical trial of NGX426, the oral prodrug of tezampanel, show that the area under the curve (AUC), which represents the total amount of drug absorbed by the body, of a single, 80 mg, oral dose of NGX426 is comparable to the AUC of a single, ...

ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study

... with advanced cancer potentially sensitive to vinorelbine. Equivalence was demonstrated by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax). The Company anticipates safety and full clinical results will be available during the first quarter ...

Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome

... ears and other ear disorders -- Low hairline -- Webbed neck -- Broad chest -- Scoliosis (curvature of the spine) -- Cubitus valgus (arms that curve out slightly at the elbows) -- Heart Defects About Norditropin Norditropin(R) (somatropin [rDNA origin] injection) is indicated for the treatment ...

Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome

... ears and other ear disorders -- Low hairline -- Webbed neck -- Broad chest -- Scoliosis (curvature of the spine) -- Cubitus valgus (arms that curve out slightly at the elbows) -- Heart Defects About Norditropin Norditropin(R) (somatropin [rDNA origin] injection) is indicated for the treatment ...

Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress

... 300 micrograms or 900 micrograms) or placebo-administered via dry-powder inhaler. The study's primary outcome measure was area under the normalized curve (AUC) of FEV1 over a 24-hour time period. Findings of a phase I single-dose study, also presented at ERS 2007, demonstrate the bronchodilatory ...

Point of Care Cardiac Analyzers Yield Rapid Cardiac Marker Results

... the analyte is quantified by interpolation from a lot-specific standard curve supplied in the test kit. The tests for CK-MB and Troponin I yield ... of the signal and control line of each test strip. There is a calibration curve for each test strip lot contained in a code chip, which is utilized by the ...

Baxter Presents Phase I Inhaled Insulin Study Results at Respiratory Drug Delivery Conference

... Study data show that RHIIP had a faster onset of action than SC (time to reach 10 percent of total area under the glucose infusion rate (GIR) curve 73 vs 95 min.; GIR-tmax 173 versus 218 min., p<0.0001). Duration of action (371 vs 366 min.) and total metabolic effect (GIR-AUC0-10h of 2,734 vs ...

ADVENTRX Announces Positive Data From Preclinical Pharmacokinetic Testing of ANX-514 (Docetaxel Emulsion)

... Pharmacokinetic analysis indicated no statistically significant (p < 0.05) differences in docetaxel maximum concentration (Cmax) or area under the curve (AUC) between ANX-514 and Taxotere. In addition, less toxicity was observed following dosing with ANX-514 than dosing with Taxotere. Taxotere induced ...

Alnylam Reports Results of Human Experimental Infection Model with Respiratory Syncytial Virus

... 72 percent of subjects were infected with a mean incubation period of 3.2 days, duration of infection of 7 days, and viral load (by an area under the curve analysis) of 61.9 log 10 PFU-days; and, -- No significant adverse events were observed. "We are pleased with the progress we have made to date ...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

... creatinine relative to placebo is not known. 7 DRUG INTERACTIONS 7.1 Digoxin There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. ...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

... creatinine relative to placebo is not known. 7 DRUG INTERACTIONS 7.1 Digoxin There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. ...

Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma

... received either BiovaxID or control vaccine. Randomization was 2:1 in favor of BiovaxID. The blinded data in a Kaplan Meier disease-free survival curve for the per-protocol treatment group in the trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 ...

Halozyme Therapeutics' Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society

... study hypothesis that rHuPH20 increases the relative bioavailability of the SC injected HUMIRA: -- For the primary endpoint of area under the curve (AUC) for adalimumab plasma concentration, the AUC over the 14 days following administration was higher when the HUMIRA was ...
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