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Clinical Trials

Reports cover package design, machinery and materials, regulatory matters, and trends and issues related to clinical trial packaging of drugs, biologics, and medical devices.

Self-adhesive film for clinical trials

• translucent, self-adhesive film neutralizes color differences between placebo and drug solutions used in clinical trials • preserves the view of the liquid fill level in a vial or syringe • adaptable to suit the color of the liquid; can...

Drug delivery device developments

Film strips, electrical current, silicon particles, and gold nanorods: Futuristic drug delivery methods are in use or in development today....

Video: Mobile blister-packaging machine

• tabletop machine for blister-packaging applications is developed for major pharmaceutical and clinical trials labs • permits flexibility for short runs at minimal costs • options include nitrogen purge, Teflon-coated forming plates, pressure boosters and batch coding to enable blister-pack...

Eli Lilly extends clinical trials materials relationship

Five-year agreement involves Lilly’s in-house clinical trial materials, including packaging and labeling operations....

FDA issues guidance to streamline medical device clinical trials

Bio-Medicine.org eports, “U.S. Food and Drug Administration issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.”...

Cancer chemo patients improve quality of life; complex sugar drug DAVANAT proven in four FDA trials*

In four FDA trials, 97 cancer patients were dosed with a combination of chemotherapy and DAVANAT. During the trials, patients taking DAVANAT experienced significantly fewer serious side effects of chemotherapy including mucositis, gastrointestinal problems, loss of hair, nausea and vomiting...

Say yes to a clinical trial; it may be good for your health*

Study finds that heart failure patients willing to take part in clinical trials have a better prognosis than those unwilling to do so....

Desire to Benefit Patients Might Undercut Research Goals, New IRB Study Finds*

A doctor who is also an investigator on a clinical trial has a patient who could benefit from the trial, but does not quite fit the eligibility criteria....

Robotics, smart conveying streamline ARUP’s specimen handling

Automation improves medical specimen handling at the University of Utah’s national reference lab, ARUP Laboratories, which is capable of storing 2.3 million samples and processing 4,000 specimens/hr....

The clinical supply chain: Strategies for scheduled drugs

Regulatory requirements in the clinical trial scheduled-drug supply chain....

The clinical supply chain: Strategies for scheduled drugs

At a time when clinical trials demand increasingly complex supply chain support, managing the special challenges associated with scheduled drugs requires meticulous planning, a thorough understanding of government regulations, and the skill to navigate them successfully....

Finland hospital study supports compliance packaging

A four-week pilot study at Kuopio University Hospital in Finland demonstrated the patient-compliance benefits of the Pharma DDSi intelligent packaging from Stora Enso....

Proofreading tools tackle clinical trial tasks

Clintrak Clinical Labeling Services employs text-inspection software and camera verification systems to automate its clinical trial proofreading functions....

Blister packaging

• CRx Pack™ is a patented F=1 blister packaging system with a senior-friendly design to assist with dosage compliance while protecting children with a proprietary locking system • carded design maintains semi-manual assembly capabilities to accommodate smaller batch runs •...

Bauer’s pharmaceutical handbook lends ‘Hall of Fame’ packaging perspective

Professionals and students will benefit from an informative research tool now available for the healthcare packaging community....

Tolmar transitions to thermoformed trays for packaging prefilled syringes

As specialists in formulating, filling, and packaging of pharmaceutical products, Tolmar, Inc. of Fort Collins, CO, has been packaging prefilled syringes for more than a decade. Using barrier thermoforming material for packaging of prefilled syringes into trays is new....

Catalent expert addresses turnkey serialization

Maintaining electronic pedigrees of your pharmaceutical products through the distribution chain is a challenge for most manufacturers. Now imagine tracking products for and with about 250 pharmaceutical companies. That's the task that will face Somerset, NJ-based Catalent Pharma Solutions,...

Healthy prognosis for healthcare packaging

Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer...

New law to require individual Rx pack numbering

A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In...

Clinical Trials Outsourced To China

Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney (www.atkearney.com), "Make Your Move: Taking Clinical Trials to the Best Location."...

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