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GLP in Medical News

Amira Announces the Successful Completion of GLP Toxicity Studies for a Novel DP2 Antagonist.

Lead candidate on track for IND submission first half of 2009. SAN DIEGO, Jan. 6 /PRNewswire/ -- Amira Pharmaceuticals, Inc. announced AM211, Amira's internally discovered oral drug candidate for the treatment and control of inflammatory and allergic diseases linked to the arachidonic acid pa...

Sunesis Pharmaceuticals Receives Milestone Payment From Biogen Idec

...BIIB ) for the selection of a Raf kinase inhibitor development candidate for the treatment of cancer. Biogen Idec is currently conducting IND-enabling glp preclinical work with the Raf kinase development candidate. "While our internal efforts are focused on the successful development of voreloxin, w...

The PDS ToxData, ReproData, and PathData User Group Meeting for 2009 Concludes - User Presentations, In-Depth Workshops and U2U Networking Dominate Agenda

...ntists to increase efficiencies and reduce time to the finished report in a glp environment, just like the rest of the PDS products. PDS also demonstr...ntroduced. A white paper by PDS staff presented latest FDA regulations and glp standards, including the SEND initiative, bringing the users up to date wit...

WuXi AppTec Receives 2009 Lilly Global Supplier Award

... providing an integrated suite of high-quality drug discovery, development and manufacturing services in a timely and cost- effective manner. Our new glp drug safety evaluation center in Suzhou and our expanded commercial manufacturing facility in the Jinshan area of Shanghai, both of which are fully co...

ASG Business Development Team Expands in Illinois

...onal Outsourcing, and Specialty Staffing services to CROs, pharmaceutical, biotech and medical device companies that require clinical operations, GCP, glp or GMP auditing, data management, statistical programming, biostatistics and medical writing solutions. Strategically organized to meet the demands of...

WuXi AppTec Bioanalytical Services Unit Passes FDA Inspection

...AS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Executive Director of BAS of WuXi AppTec. "We maintain glp readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data an...

SAFC(R) Underlines Commitment to Pharmaceutical Supply Chain Quality With New Global Vendor Audit Services

...f regulatory standards including but not limited to ISO 9001:2008 (previously ISO 9001:2000), ISO 13485:2003, 21 CFR 211, 21 CFR 820, ICH Q7A, GAMP 5, glp and 21CFR58 compliance requirements. SAFC can also perform custom audits to suit individual customer specifications. "SAFC understands that ensu...

ChanTest to Highlight Expanded Ion Channel and GPCR Services and Cell Lines, Including FDA Critical Path Safety Profiling Tools at ToxExpo, Booth 3056

...ChanTest has validated these panels against the "gold standard" manual patch clamp assay to ensure that results from early screens will correlate with glp study results that are required for IND submission. For customers that prefer to do their own testing in house, ChanTest offers its catalog of va...

WuXi AppTec Successfully Holds Its 2009 Supplier Conference in Shanghai

... and look forward to building on its solid base of business. ''We also made substantial progress in 2008 in constructing two new facilities-the glp Drug Evaluation Center in Suzhou, one of the largest in Asia, and an expansion of the manufacturing facility in the Jinshan area of Shanghai. Both fac...

WuXi PharmaTech Honored on the Deloitte Technology Fast 500 Asia Pacific 2008 List for the Fifth Consecutive Year

... progress in expanding our service portfolio to provide a global, fully integrated, high-quality R&D service platform. Our ongoing work to begin glp toxicology operations in Suzhou, in what will be the largest such facility in China, and to integrate WuXi operations with those of U.S.-based AppTec ...
GLP in Medical Technology

Medizone International, Inc. (MZEI.PK): Trials of the AsepticSure Hospital Sterilization System Have Begun

...equipment is superbly designed with full computer control of all test parameters and hence, we are confident that the entire series of studies will be glp compliant. If these trials successfully demonstrate that our equipment and protocols are fully effective at eliminating the bacteria being tested, as...

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

...th the potential for once-daily or twice-daily oral dosing. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day glp toxicology studies. In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598. If ANA598 is successful in early stag...

SeqWright's Clinical Trial Support Contributes to the Approval of Two HPV Diagnostic Systems

... Good Laboratory Practices (GLPs) as specified in the Code of Federal Regulations. Sequencing for Hologic's clinical trials was performed under glp guidelines (4X-bidirectional sequencing, stringent controls, full documentation) and all samples were continuously tracked and monitored. The bioinfo...

American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule

...n evaluated in various in vitro and in vivo models. Toxicity of this product was assessed through a series of toxicity studies under the conditions of glp (Good Laboratory Practices) in China. AOBO has filed several patents in the past 12 months to protect the intellectual property of AOBO-001. A...

ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients

...th the potential for once-daily or twice-daily oral dosing. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day glp toxicology studies. In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598. If ANA598 is successful in early stag...

Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Type 2 Diabetes Drug Candidate in Partnership with Ortho-McNeil-Janssen Pharmaceuticals

...other than pancreatic beta cells, such as endocrine cells in the gastrointestinal tract, and in preclinical studies the GDIR stimulates the release of glp and GIP, two incretins that play an important role in insulin regulation and glucose homeostasis. GDIR stimulation has also been found to increase the...

Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers

...nitiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day glp toxicology studies. In September, Anadys initiated long-term chronic toxicology studies of ANA598. If ANA598 is successful in early stage clinical tri...

Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients

...nitiation of clinical investigation in the second quarter of 2008. In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day glp toxicology studies. Furthermore, ANA598 was shown to be active in a primate model of chronic HCV infection, leading to a greater than 2 log viral load...

Anadys Pharmaceuticals Resumes Clinical Investigation of TLR7 Mechanism in HCV

...ed on preclinical pharmacology testing and the results of completed 13-week glp animal toxicology studies, Anadys has received clearance to initiate a clin... dose and schedule of administration. Results of recently completed 13-week glp toxicology studies have shown that with every-other-day dosing of ANA773, i...

Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598

...0 values for genotypes 1b and 1a replicons are 3 and 50 nM, respectively). ANA598 has been well-tolerated in all preclinical studies, including 28-day glp toxicology studies, and was selected as a development candidate in June 2007. Clinical Need and Market Opportunity in HCV Infection Chronic hepati...
GLP in Medical Products

Pipette Tracker

Description:...devices. Collects weights directly from any balance Supports all gravimetric calibration protocols Meets ISO 8655, DIN 12650, ISO 9000, NCCLS and glp requirements Includes setup information for balances Includes a database of manufacturers calibration specs for over 700 pipettes Interfaces wit...
Company:Labtronics, Inc.

Milli-Q Element System (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Element A10 System

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Synthesis (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Synthesis bench-integrated system (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Synthesis System (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Synthesis A10 bench-integrated system

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Biocel bench-integrated system (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Synthesis A10 System

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore

Milli-Q Biocel System bench-integrated system (non-TOC)

Description:...fication services are available, and the optional Explore Data software allows easy access to historical data via a computer interface for documenting glp compliance. All systems can be bench-operated, wall-mounted or bench-integrated for maximizing space requirements. All systems in the Milli-Q range e...
Company:Millipore
GLP in Medical Dictionary

Retrovirus

... Retroviruses are a sub-category of oncoviruses that include the ... All retrovirus vectors produced in the VDL are produced in compliance with glp standards. ... Encyclopedia article about defective virus. Information about defective virus in the Columbia Encyclopedia, Computer ... A retro...
GLP in Biological Technology

American Oriental Bioengineering Reports Second Quarter 2009 Financial Results

...$33.3 million in revenue during the second quarter of 2009, up from $29.4 million in the prior year's period, reflecting continued demand for Boke and glp products, as a result of marketing efforts and improved recognition of the products. Nutraceutical products generated revenue of approximately $9.5 mi...

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

...rial for the treatment of hepatitis C. During the second quarter of 2008, ANA773 development costs were primarily driven by the now completed 13-week glp animal toxicology studies and the Phase I oncology clinical trial. The ANA598 development costs during the second quarter of 2009 were primarily asso...

Sunesis Reports Financial Results for the Second Quarter 2009

...BIIB ) for the selection of a Raf kinase inhibitor development candidate for the treatment of cancer. Biogen Idec is currently conducting IND-enabling glp preclinical work. Sunesis retains an option to participate in the co-development and co-promotion of the Raf kinase inhibitor resulting from this coll...

Sundia MediTech Appoints Dr. Tong Xu as VP of Process Chemistry

... Wang, Chairman and CEO of Sundia. "Dr. Xu led the effort in his previous employment to search, select, negotiate and qualify CRO service providers in glp and cGMP production of raw materials, starting materials, and API intermediates. This experience is very valuable for his new role to lead process ch...

Assessment of safety and efficacy of human embryonic stem cell therapy

...eas the untreated animals only had a single layer of cells remaining (they were essentially blind). Based on these data, a cell batch was chosen for a glp safety study using the NIH III mouse model, an immune deficient animal model. Importantly, we also showed that vision can be rescued in a mouse model...

Call for papers for Pira International's Global Crop Protection Summit 2009

...ategories:    (1) Emerging geographic markets: India, Russia and the Ukraine,    (2) Regulatory updates: REACH and glp    (3) Pest and disease trends    (4) Pesticide innovation    (5) Challenges facing the industry: the ...

CRO Acquisition Seen Boosting Activity, Positioning ASG, Inc., for New Growth in Q2

...onal Outsourcing, and Specialty Staffing services to CROs, pharmaceutical, biotech and medical device companies that require clinical operations, GCP, glp or GMP auditing, data management, statistical programming, biostatistics and medical writing solutions. Strategically organized to meet the demands of...

SeqWright Expands into the Genetically-Targeted Therapy Field by Partnering with PharmaGenoma to Provide Next-Generation Hair Loss Treatment Genetic Testing

... HOUSTON, April 28 /PRNewswire/ -- SeqWright Inc., a CLIA certified and glp compliant provider of custom genomic and molecular biology services, announced today its entry into the genetically-targeted therapy field through its...

WuXi PharmaTech Announces Fourth-Quarter and Full-Year 2008 Results

...xpenditure levels; and our planned investments in building our talent pool of scientists, in our toxicology facility in Suzhou and related non-GLP and glp toxicology service capability by the second half of 2009 and mid-2010, respectively, and in our Jinshan facility with the intent of opening it by the ...

WuXi AppTec Welcomes Three Senior Professionals

... Robert Coldreck has joined the company as Head of glp (Good Laboratory Practice) QA (Quality Assurance)....He brings more than 30 years of rich experience in glp quality assurance. Mr. Coldreck received his B.S. .... Li. "With their rich experience and knowledge in glp preclinical studies and their strong leadership in...
GLP in Biological Products

Mouse Anti-Human GLP Monoclonal Antibody, Unconjugated, Clone 1B7B4 from ProMab Biotechnologies, Inc.

Description: Monoclonal Antibody to GLP Immunogen: Ni-NTA purified truncated recombinant GLP expressed in E. Coli strain BL21 (DE3)...
Company:ProMab Biotechnologies, Inc.

ULTROSPEC 6300 from GE Healthcare, formerly Amersham Biosciences

Description:.... Ultrospec 6300 pro UV/Visible Spectrophotometer: * Meets the demanding requirements of the Pharmacopoeia in terms of instrument specification and glp self-diagnostics, with the benefits of being able to be used for rapid, discrete measurements. *Bandwidth of 1.0 nm and excellent scanning capability...
Company:GE Healthcare, formerly Amersham Biosciences

Fermentation Services from Wisconsin Bioproducts

Description:... Versatile state of the Art glp facility with capabilities from shake flask to dual 38,000 L fermentation. Coordinated process development from pilot scale to production. Aseptic o...
Company:Wisconsin Bioproducts

Fluorescence Test Plate from BioTek Instruments

Description:... in polymerized matrix. It is designed to be used on BioTeks FLx800 and Synergy Multi-Detection Readers. This multi-functional test plate is ideal for glp compliance while reducing the need for tedious wet testing. Works with all models of FLx800 and Synergy readers....
Company:BioTek Instruments

Pipette Tracker from Labtronics, Inc.

Description:...devices. Collects weights directly from any balance Supports all gravimetric calibration protocols Meets ISO 8655, DIN 12650, ISO 9000, NCCLS and glp requirements Includes setup information for balances Includes a database of manufacturers calibration specs for over 700 pipettes Interfaces wit...
Company:Labtronics, Inc.
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