Toxicological Insights for the Global Pharmaceutical Industry
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New Procedure Cage Reduces Primate stress
New procedure cage attaches directly to an animal’s home cage and eliminates hand capture or use of other restraints, creating calmer handling environment.
FDA New Drug Reviews: Past and Future Perspectives
This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.
FDA Pharamacogenomic Biomarker Database
A resource table listing FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.
PDUFA V: Risk – Benefit Emphasis New
In examining drug safety, the PDUFA V legislation places new emphasis on the risk vs. benefit of new drugs.
FDA Resource for Approved Drug Information
Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?
New Hypersensitivity Screen for Drugs
Researchers find new way to screen drugs for adverse hypersensitivity reactions before use.
Preclinical Safety Testing: Use of Transgenic Animals
Transgenic and genetically modified animal models are increasingly being used in the study of disease and for the safety assessment of new compounds.
Sexual maturity in primates: new challenges for drug safety evaluation
Use of sexually mature primates in toxicology is providing new opportunities and challenges.
Drug Safety: Tip of the Iceberg
The 10 drugs with the largest number of adverse event reports sent directly to the FDA in 2011 are detailed.
US, Canada, and EU – Who wins the Drug Approval Race?
The US FDA leads its EU and Canadian regulatory counterparts in approving more novel drug applications faster over the last decade.
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