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.

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.

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.

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.

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.

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.