Crossover in Biological Technology

Study Showed VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment

... Environment Study This randomized, double-blind placebo-controlled, crossover study evaluated the efficacy and safety of three doses of VYVANSE, 30 mg, ... hours after dosing at two visits (visits 5 and 6) during the double-blind crossover phase. VYVANSE demonstrated significant improvement in the average ...

Nikon Instruments Provides Donation to Help Clemson University Start New Core Microscopy Facility

... well as establish the facility as a premier training facility in these top crossover instrumentation uses. "Nikon chose to provide this donation to Clemson ... the optical instrumentation and analysis software will provide for superb crossover applications to be conducted." "The donation by Nikon dramatically ...

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

... SPRYCEL; 15 of 101 patients receiving SPRYCEL had crossed over to Gleevec. crossover to alternate therapy was permitted in the event of disease progression or intolerable toxicity. Median duration of treatment prior to crossover was 14 months for SPRYCEL and three months for Gleevec. Incidence of ...

Study Published in Child and Adolescent Psychiatry and Mental Health Demonstrated Once-Daily Vyvanse(R) (lisdexamfetamine dimesylate) CII Provided Significant Improvement of ADHD Symptoms for Children at 13 Hours After Administration

... Following a four-week, open-label, dose-optimization phase with Vyvanse at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of Vyvanse the first week and placebo the second week. The ...

FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

... Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The ...

Poniard Pharmaceuticals to Present Final Data from Picoplatin Phase 1 Clinical Trials at American Association for Cancer Research's 100th Annual Meeting

... Breitz H, De Jager R. Tuesday, April 21, 8:00 a.m. MDT Clinical Research 11 Session Hall B-F, Poster Section 30 A Phase 1 randomized crossover oral picoplatin bioavailability pharmacokinetics and pharmacodynamics study Abstract #3594 Phillips A, Saleh M, Yee L, Sharma S, Houston ...

Horizon Therapeutics Selected to Present at InsideVenture's Debut Investor Conference March 25-26, Santa Barbara, California

... prior to an eventual IPO. The companies will present their businesses to qualified institutional buyers (QIBs), including mutual fund managers, crossover funds, late stage VC & PE funds and strategic corporate investors. Investors interested in attending the conference may apply for an ...

Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia

... the findings to demonstrate remarkable efficacy in this patient population. This Phase II trial was a double-blind, placebo controlled, 4-way crossover design comparing placebo to 3 doses of ITI-007 (1 mg, 5 mg and 10 mg) in patients with SMI. Analysis of key objectives in this study indicated that ...

Romark Announces Presentation of New Data for Controlled Release Nitazoxanide in Chronic Hepatitis C

... following oral administration of nitazoxanide at 675 mg or 1,350 mg twice daily with food for seven days. This was a randomized, double blind crossover study. The 675 mg and 1,350 mg twice daily doses of controlled release nitazoxanide produced trough plasma concentrations of tizoxanide, the active ...

Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)

... NDA follows the successful completion of two Phase 3 clinical trials. The first Intermezzo (R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. Results from ...

Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients

... insulin program into the clinic before the end of the year and I congratulate the Halozyme team for its outstanding performance." This exploratory, crossover design, single blind, open label, liquid meal Phase 2 study is designed to collect data on at least 20 patients who complete the study. The study ...

Using living cells as nanotechnology factories

... the very first branched nanostructure made up of DNA- a cross-shaped, four-arm DNA junction and another DNA junction structure containing a different crossover topology. To copy these branched DNA nanostructures inside a living cell, the ASU and NYU research team first shipped the cargo inside a bacteria ...

deCODE genetics Announces Second Quarter 2008 Financial Results

... next-generation oral anti-platelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current anti-platelet ...

Faith Haines Kolb Joins PROMETRIKA as Senior Director of Clinical Operations and Data Management

... to pharmaceutical, biotechnology and medical device companies. PROMETRIKA's team has managed hundreds of clinical trials from Phase 1 pharmacokinetic crossover trials to Phase 4 long-term multi-center studies. The company has extensive experience in all areas of clinical trial management, including strategic ...

Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation

... measures were comparable between FFIS and FA. The second study involving thirteen COPD patients was a randomized, single-dose, open-label, crossover study comparing FFIS 10, 20, and 24mcg with Foradil(R) Aerolizer(R), which confirmed pharmacokinetic comparability between Perforomist(TM) Inhalation ...

ANX-530 Demonstrates Equivalent Pharmacokinetics to Navelbine(R) in a Registrational Bioequivalence Clinical Study

... the FDA within its 10 month review goal, may generate revenues for the company towards the end of 2009." The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining ...

Sweet nanotech batteries

... large volume change during alloying and de-alloying. Carbon nanotubes resemble rolled-up sheets of hexagonal chicken wire with a carbon atom at the crossover points of the wires and the wires themselves being the bonds between carbon atoms, and they can be up to a millimeter long but mere nanometers in ...

Virgin Atlantic to Offer Zero-Emissions GM Hydrogen Fuel Cell Limousines to Upper Class Passengers

... commercial environment." Powered by GM's fourth-generation fuel cell propulsion system, the Equinox Fuel Cell electric vehicle is a fully-functional crossover vehicle. Fuel cell technology and hydrogen fuel represents a step change for the automotive industry and will substantially reduce the industry's ...

It's Good News for The Lungs!

... MIAMI, Jan. 28 /PRNewswire/ -- The Expand-A-Lung Breathing Resistance Exerciser has successfully accomplished the crossover from the sports respiratory fitness training market into the respiratory therapy market for COPD patients. Jorge Brouwer, President of Expand-A-Lung, ...

ANX-514 Reduces Hypersensitivity Reactions Without Impacting Pharmacokinetics or Antitumor Activity in Preclinical Tests

... administration of ANX-514; specifically, no treatment-related change in blood pressure and no increase in histamine levels were observed. In this crossover design study, even on re-challenge at 3 weeks, hypersensitivity reactions were observed only in the Taxotere treated animals. In two separate studies ...

What patients want: A story of choice, clinical trials & evidence-based medicine

... course of the trial, patients could request to crossover to the other treatment. Patients who were ... and vice versa. That muddied the data. crossover vote It would seem, however, that this huge crossover rate also provided another, extremely important ...

Detection of Variation in Highly Polymorphic Mhc Genes by Denaturing Gradient Gel Electrophoresis Using the DCode System

... still apparent (despite the GC-clamp), and elucidated the crossover point between alleles 9 and 10 at nt position 207 (Figure 2). This crossover point directly coincided with the location of the 2 codon ...

Technology in the ditch

... again. Other ditch-related questions Without going into too much detail there are some other questions worth asking. Is this a ditch or just a crossover to a better road? Its amazing what we discover if we look beyond what we expect to see. Was that smooth road just a dream, a group hallucination? ...

Study explains unexpected conductivity of nanoscale silicon

... samples, like the scanning tunneling microscopy method employed by Zhang - can also be used to explore the nanoworld. "We're working at the crossover between silicon electronics and nanoelectronics," says Evans. "This material is the same size as nano-devices like silicon nanowires and quantum ....

Zillow changes the real estate pricing game

... Zillow was founded by two veterans of Expedia, Rich Barton and Lloyd Frink. The Seattle-based company is funded by Benchmark Capital and Technology crossover Venture (TCV), as well as private investors. Chris Shipley is the executive producer of NetworkWorld's DEMO Conferences, Editor of DEMOletter and ...

UW-Madison hybrid-vehicle team places second nationally

... appropriately named the "Moovada," could one day be incorporated into mass-production hybrid SUVs. The effort is part of a contest, " Challenge X: crossover to Sustainable Mobility ," sponsored by General Motors and U.S. Department of Energy. June 8th, in Mesa, Ariz., the UW-Madison team was awarded ...

Four New CastAway Precast Gels

... eliminate the need to insert a sharks-tooth comb into the gel, simplifying set up and sample loading. Preformed wells also lessen the risk of crossover from neighboring gel lanes, reducing contamination of adjacent samples. Each well is 3.5-mm wide for easy rinsing and loading of sample volumes ...