Regulatory Review

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Top Regulatory Review Company
Rules-Based Medicine  Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from...
PDi-Pharmaceuticals  Mission Statement: Our mission is to provide the best quality, cost effective solutions to our clients in the areas of Active Pharmaceutical Ingredients, Regulatory Services and Finished Dosage products. History: PDi...
Top Regulatory Review Company
The Jackson Laboratory  We help researchers discover treatments, preventions and cures for human disease through the provision of inbred, mutant and genetically engineered mouse models, research services, and comprehensive technical information...
Endpoint, LLC  Endpoint, LLC provides biotech, pharma, and VC clients with high-quality, authoritative evaluation and advice on all aspects of the clinical development of drugs and devices.
Eolas Biosciences  Eolas Biosciences has been supporting bioscience companies worldwide since 2005. Eolas has worked with a wide range of clients, from early-stage ventures to Fortune 500 companies in the pharmaceutical, biotech and...
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Regulatory Review Research Library

Evaluating Pregnancy Outcomes: Prospective Pregnancy Registries vs, Administrative Database Analyses
United BioSource Corporation
Women of childbearing age are susceptible to a wide range of medical conditions that require chronic therapy such as diabetes, depression, epilepsy and asthma. If they become pregnant, they must also face questions regarding the po- tential impact of their medication on the risk of birth defects. Those who seek materials regarding the potential effect of medications on risk of malformation are ...
 
Modeling Inflammatory Bowel Disease and Psoriasis in Mice Through T Cell Adoptive Transfer
The Jackson Laboratory
Epidemiologic analysis has revealed the association of psoriasis with inflammatory bowel disease (IBD) in humans. In mice, transfer of CD45RBhi CD4+ naive T cells into immunodeficient animals induces colitis and psoriasis-like phenotypes. This sample study describes the utility of such an adoptive transfer model to evaluate novel compounds for the treatment of IBD and psoriasis.
 
REMS and the FDAAA
Beckloff Associates
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, ...
 
EDC and CDISC, The Perfect Combination for Successful Submission
SGS Life Science Services - Clinical Research
Since EDC has become a valid alternative for paper-based trials, we are more often confronted with the problem of trial specific database structures, which are inherent to EDC. The lack of standards makes inter-department and inter-organizational collaboration difficult. A standard database structure, as prepared by the SDS team of CDISC would certainly facilitate the collection, exchange, ...
 
p53 and MDM2: Partners in Repair and Death
EMD Chemicals Inc.
In unstressed cells, p53 is latent and is maintained at low levels by targeted degradation mediated by MDM2. Through its binding to p53, MDM2 can shuttle p53 out of the nucleus into the cytoplasm for degradation. When normal mammalian cells are subjected to stress signals, such as hypoxia, radiation, and chemotherapeutic drugs, p53 is phosphorylated at multiple sites, including those involved in ...
 

Regulatory Review Video

Nano Pipettor Hamilton Robotics Video on the Nanopipettor: 100 nl dispens on the fly raster: 1536
 
Biosafety Cabinets Labconco Corp. Learn how to provide protection for personnel, products and the environment from hazardous materials in this short video.
 
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