Toxicological Insights for the Global Pharmaceutical Industry
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FDA Changes Expected with PDUFA V
The implications and timing of the new PDUFA V mandates on the drug development are discussed.
Nonclinical Cardiotoxicity Testing: Stem Cell Use
In addition to ion channel testing (e.g., hERG), use of stem-cell-derived cardiac myocytes allows assessment of other functions critical to cardiac cell health.
TigerTox: Lack of sleep correlates with Alzheimers – FierceBiomarkers http://t.co/V3wMZ0qP #in #pharma #neuro #CNS
TigerTox: Lack of sleep correlates with Alzheimers – FierceBiomarkers http://t.co/V3wMZ0qP #in #pharma #neuro #CNS
Zebrafish: Preclinical Screening and Toxicity Assessment
Zebrafish offer a nonclinical model for the high-throughput screening of drug compounds, including toxicity assessment, with resolution at the cellular level in living vertebrate organisms.
Adverse Preclinical Events – Now What?
This presentation outlines the process for dealing with adverse preclinical / nonclinical events in order to 1) optimize the chances of successful drug development, or 2) to create a scientific basis for early termination of drug development.
Is Pharmaceutical Collaboration an Oxymoron?
Pharmaceutical companies that share drug development risks and costs are better able to negotiate reimbursement and defend competition, but legal complexity is increased.
Dried Blood Spot Analysis: Preclinical Considerations
Some preclinical considerations of utilizing dried blood spot analysis/dried matrix spotting include the regulatory ambiguity of validation guidelines, variations due to differential hematocrit, blotter paper standardization, and use with alternate limited-volume body fluids.
Drug Labels: Toxicity or Information Overload?
Information overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Although providing drug safety information more efficiently to both health care providers and the public is warranted, drug manufacturer liability concerns must also be addressed.
Translational Toxicology: Biomarker Development
Translational toxicology: a review of the status of both qualification and validation of translational biomarkers.
Drug Abuse Liability Testing
New drugs that penetrate the central nervous system (CNS) must undergo analysis of abuse liability potential (e.g., behavioral pharmacology, animal drug discrimination, and self-administration data). Multiple variables must be considered.
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