Toxicological Insights for the Global Pharmaceutical Industry
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High-throughput ADME Screening Technologies
New methods in high throughput absorption, distribution, metabolism, and excretion screening technology (HT-ADME) are discussed relative to pharmaceutical safety and toxicology.
Drug Safety: Global Regulatory Authorities Encouraged to Share Inspection Results
Global regulatory authorities are encouraged to mutually recognize inspection results, which would eliminate the wasteful duplication of effort and enhance drug safety.
Nonclinical Toxicology: FDA Guidance Agenda for 2012
The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. The proposed nonclinical safety documents are highlighted.
Nonclinical Toxicology Sector Predictions for 2012
The preclinical toxicology sector is not merely going through a prolonged cyclical slowdown, but has also structurally changed. Growth of this sector in 2012 is expected to be weak; new business models are evolving.
FDA Pre-IND Meetings: Why, When and How
Introduction to U.S. FDA pre-IND meetings ─ why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.
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.
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