Navigation Links
Qualyst Transporter Solutions, LLC Announces Launch of New FDA Services Offering
Date:6/26/2012

RESEARCH TRIANGLE PARK, N.C., June 26, 2012 /PRNewswire-iReach/ -- Qualyst Transporter Solutions, LLC has launched a contract service offering using a clinically-relevant model to assess FDA concerns on drug transporter related hepatic drug-drug interactions.  The newest FDA draft guidance on drug interactions (February, 2012) specifies six hepatic drug transporters of interest, which include three uptake and three efflux transport proteins.

"What is missing in the market is a way to address FDA concerns around transporter-based drug interactions that is predictive of an in vivo outcome." said Dr. Christopher Black, CEO for Qualyst Transporter Solutions.  "Utilizing the gold-standard sandwich-culture hepatocyte model, we have applied our clinically-relevant B-CLEAR® technology in order to produce a cost-effective answer to the FDA's concerns," said Dr. Black.

Many of the ways that current technologies try to address the FDA concerns involve in vitro transfected systems.  Data from these systems are difficult to translate into reliable in vivo knowledge. An integrated in vitro system, like hepatocytes, with multiple localized, functioning, and expressed uptake and efflux transporters, is required to accurately predict and describe in vivo transporter-based drug interactions.

Experiments can be performed in hepatocytes from multiple species, including humans, and the streamlined results are provided as a percent change from control.  Clinically relevant positive controls are included in order to gauge the relative inhibitory potency of the tested compounds.  Qualyst Transporter Solutions has a large historical data base which can help provide clinical perspective on the effects of your compound for an FDA submission.   This can be important since many models overestimate inhibitory interactions or there may be inhibitory effects on a single transporter that ca
'/>"/>

SOURCE Qualyst Transporter Solutions, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Chandler Chicco Companies Acquires Haas & Health Partner Public Relations and SanCom Creative Communication Solutions, Creating Unrivalled Healthcare Communication Capability in Germany
2. Amarillo Biosciences Announces Plan to Open Asia Operations Center in Taipei, Taiwan
3. Bronstein, Gewirtz & Grossman, LLC Announces Investigation of American Oriental Bioengineering Inc.
4. Pacific BioStorage Announces an Exciting New First for The Life Sciences Industry in Southern California
5. JH Technologies Announces Launch of Their New Website
6. Cetero Research Announces Executive Appointments and New Company Name
7. American Botanical Council Announces New Publication "Herbal News & Events"
8. SEE ALGAE Technology GmbH Announces Sale of Algae Farm to Brazils Grupo JB
9. 5AM Solutions Announces Release of the Ion AmpliSeq™ Designer v1.2
10. Kitware Announces Opening of Santa Fe Office
11. Keryx Biopharmaceuticals Announces Live Webcast of Upcoming Analyst Day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... 18, 2014 Today, TiFiber, ... pilot production facility and future company headquarters in ... innovative new materials that safely and effectively control ... because of its historic, strong support for manufacturing, ... attract leading edge, technology-based companies such as TiFiber. ...
(Date:12/19/2014)... iLab Solutions, the global leader in ... Bryant as the new Director of Institutional Implementations and ... These two new leadership positions were created to support ... that iLab continues to meet the needs of its ... iLab has been deployed at over 450 core facilities ...
(Date:12/19/2014)... , Dec. 18, 2014  Decision Resources Group ... dental biomaterial market will grow moderately through 2023 as ... and growing awareness of dental biomaterials all spur procedure ... such as China and ... bring dental procedures within reach for a larger proportion ...
(Date:12/17/2014)... December 16, 2014 The Activated ... 2013, which is why IBISWorld updated its original industry ... to benefit from an intensified focus on environmental policy. ... new emission standards for power plants and a range ... to IBISWorld Industry Analyst Sarah Kahn, “a range of ...
Breaking Biology Technology:Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 2Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 4iLab Solutions Announces Two New Leadership Positions to Meet the Needs of Its Growing Customer Base 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 3Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 2Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 3
... p.m. PT ... (5:00 p.m. ET), IRVINE, Calif., ... CO-Oximetry and,Measure-Through-Motion- and-Low-Perfusion pulse oximetry, today announced,it will release third quarter financial ... Monday, October 27, 2008., A conference call to review the results ...
... Calif., Oct. 15 SuperGen, Inc.,(Nasdaq: SUPG ... and,development of novel cancer therapies, today announced the ... EORTC-NCI-AACR Symposium on "Molecular,Targets and Cancer Therapeutics" on ... will review clinical and non-clinical advances,in the following ...
... SourceSolution, a leader in,search technology for the biotechnology ... target to launch a new initiative next month,which ... manufacturing and,research organizations (CMOs/CROs). The proprietary technology will ... Service (SaaS) database. The,database will allow users to ...
Cached Biology Technology:Masimo to Report Third Quarter 2008 Financial Results on October 27, 2008 2SuperGen to Present Data at EORTC-NCI-AACR 2SourceSolution Announces the Launch of Its Initiative to Simplify Outsourcing Decisions for Biotechnology and Pharmaceutical Companies 2
(Date:11/21/2014)... , Nov. 20, 2014 C-Labs LLC, ... the Internet of Things (IoT), today announced the appointment ... chief operating officer. Previously a strategic advisor to the ... and operations. Mr. Traynor is based out of the ... He reports to Chris Muench , Chief Executive ...
(Date:11/18/2014)... 2014  The Secure Identity & Biometrics Association ... announce the formation of The Airport Entry and ... Identity and Biometric Entry and Exit Solutions Framework ... support from BORDERPOL, the international non-profit organization that ... expertise regarding border security, traveler and migration systems. ...
(Date:11/18/2014)... BETHESDA, Md. , Nov. 17, 2014 The ... European and U.S. regulatory agencies will speak and at least ... Quality Metrics Conference at the Omni Shoreham Hotel in ... is pleased once again to have significant support from the ... and Europe in our effort to ...
Breaking Biology News(10 mins):C-Labs Names Former Microsoft and Bsquare Executive as Chief Operating Officer 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 3FDA's Janet Woodcock, EMA's Emer Cooke Headline PDA Quality Metrics Conference 2
... a serious environmental, economic and social problem worldwide as ... ecosystem functions, such as nutrient cycling. Despite substantial research, ... new habitats over native plants that technically should have ... is that these plants are more abundant in introduced ...
... Invasive plant species are a serious environmental, economic ... lost native biodiversity and ecosystem functions, such as nutrient ... about why some species dominate new habitats over native ... common but rarely tested assumption, say biologists, is that ...
... (Feb. 1, 2011) -- Rice University bioengineers and physician-scientists ... have successfully destroyed tumors of human brain cancer cells ... treatment that zaps glioma tumors with heat. The tests ... tumors with heat and avoid the unwanted side effects ...
Cached Biology News:Home and away: How do invasive plant species dominate native species? 2Home and away: Are invasive plant species really that special? 2Early tests find nanoshell therapy effective against brain cancer 2
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Request Info...
QML offers standard and customized paraffin embedded tissue blocks....
Biology Products: