Toxicological Insights for the Global Pharmaceutical Industry
BLOG
Advantages of Incremental Innovation in Drug Development
Most new drugs represent a combination of small improvements achieved over time and ultimately reflect advances in safety, efficacy, selectivity, and drug utility.
Drug Labels May Inadequately Address Efficacy and Risk
Drug labels may insufficiently address efficacy and risks/toxicity. Label changes, among others, have been proposed and are under review by the FDA.
New Center of Excellence for Regulatory Science proposed by FDA
New center of excellence in regulatory science proposed by the FDA will bring academia, FDA, and industry together in collaboration.
Australian TGA adopts ICH M3(R2) Nonclinical Guidance
The Australian TGA has adopted the EU ICH M3(R2) guidance for nonclinical (toxicology) safety studies of pharmaceuticals.
New FDA Transparency Impacts Drug Safety
Analyses of publically available clinical data may present the FDA with a more complex picture of drug safety, but may complicate regulatory assessment.
How to ensure the long-term safety of chronic use drugs?
Drug safety may be underestimated for chronic-use drugs.
Why is naming a drug so difficult?
The FDA published a guidance (February 2010) detailing the methodology for evaluating proposed proprietary drug names.
Blockbuster Drug Potential: Importance of Risk Management
Following 120 total votes between 2007 and 2010, the FDA followed its expert panel’s advice 74% of the time and negated “no” votes only thrice.
Genetic Toxicology: Historical and Current Perspectives
Historical and current perspectives on genetic toxicology, with commentary and slides on assay predictivity and shortcomings, regulatory guidance, and high-throughput screens to enhance preclinical drug safety.
Accelerate Drug Development: New Preclinical Models and ADME/Toxicity Screens
This report 1) explores novel preclinical models (in vivo, in vitro, in silico, and systems biology) that show promise to expedite and improve the target validation, lead optimization, and toxicity screening timelines, and 2) discusses the various advantages and disadvantages of Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) screening techniques.
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