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new draft FDA guidance on pediatric clinical assays

Posted by Neoteryx on Sep 11, 2019 4:56:00 AM

Clinical trials must run smoothly to facilitate the development of new drugs. These trials must be conducted under specific guidelines to abide by the law that protects both the test subjects and the companies conducting trials. Below is a summary of the new Draft FDA Guidance on Pediatric Clinical Assays.

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Topics: Clinical Trials, Pediatrics

AKU, NTBC, and VAMS®: fighting a rare metabolic disease

Posted by Neoteryx on Aug 15, 2019 5:51:00 AM

The Challenge of AKU

Alkaptonuria, or AKU, is a rare and less-studied inherited metabolic disorder. It results from a deficiency of homogentisic acid dioxygenase (HGD), part of the tyrosine degradation pathway. As of yet, there is no cure. However, The National Centre for Alkaptonuria, hosted by The Royal Liverpool and Broadgreen University Hospitals, is supporting international clinical trials that may help change that. And clinical chemist Joseph Taylor says that Volumetric Absorptive Microsampling (VAMS®) technology and Mitra® devices already play an important role in the relevant drug development process.

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Topics: Clinical Trials, Capillary Blood Sampling, Smarter Healthcare, Patient Monitoring

microsampling in clinical trials: 6 things you may not know

Posted by Neoteryx on Jul 23, 2019 12:34:00 AM

Microsampling is gaining popularity as an alternative to conventional sampling in clinical trials. The reasons have to do with people, just the laboratories. Patients like the VAMS™ system. It’s much easier on them and less time-consuming. Parents are particularly happy when microsampling is used to sample from babies and children.

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Topics: Clinical Trials

clinical trials: how dangerous are they?

Posted by Neoteryx on Jul 17, 2019 5:15:00 AM

Clinical trials are essential to the advancement of medicine. New drugs and devices are tested on people as the last step before the drug or device becomes available to those who need it.

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Topics: Clinical Trials

process improvement in clinical trials: how smaller samples make a big difference

Posted by Neoteryx on Jul 2, 2019 7:02:00 AM

Technological progress is enabling vast improvements in pharma, in drug development, and across the new landscape of healthcare. Clinical trials are at the forefront of bringing new treatments to market in a safe and timely manner. To keep up with the times, constant process improvement in clinical trials is therefore essential. New blood microsampling systems using Mitra® devices, driven by Volumetric Absorptive Microsampling (VAMS™) technology, function as an essential link between the promise of smarter healthcare, the new wave of clinical trials, and the stuff of human life.

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Topics: Clinical Trials

[WEBINAR REPLAY] the science of smarter sampling for drug development

Posted by Neoteryx on Jun 26, 2019 4:40:00 AM

Update: This event has now ended. The on-demand replay is now available.

We get a lot of questions about the specifics of succeeding with microsampling technologies in the bioanalytical lab, as well as some larger questions around applications in pharma, in clinical trials, and across the spectrum of clinical trials. This is your chance to have your questions answered, including the ones you didn't even know you had.

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Topics: Clinical Trials