Tag Archives: toxicology

Toxicological/Safety Evaluation of Dietary Supplements Containing Vitamins and Minerals

By Harsh Sancheti, Ph.D., Medical Writer at Cato Research Dietary supplementation of certain vitamins and minerals has resulted in significant positive public health outcomes. Some notable examples include folic acid fortification in wheat or maize flour that has reduced the … Continue reading

Posted in Cato Research, Clinical Trials, Toxicology | Tagged , , , , , | Comments Off on Toxicological/Safety Evaluation of Dietary Supplements Containing Vitamins and Minerals

Toxicological/Safety Evaluation of Herbal Supplements and Botanical Combinations

Toxicological/Safety Evaluation of Herbal Supplements and Botanical Combinations by Harsh Sancheti, Ph.D., Medical Writer at Cato Research Plants all around us show an astonishing ability to grow in some of the most taxing conditions, fight deadly viruses (without even a … Continue reading

Posted in Cato Research, Toxicology | Tagged , , , | 1 Comment

Toxicokinetic Tips

Richard Stewart Ph.D.; Director, Nonclinical Safety Development; Cato Research A key component of toxicology studies is the toxicokinetic (TK) assessment. A common question from our Sponsors is, “What’s the difference between pharmacokinetics (PK) and TK?” A straightforward answer is that … Continue reading

Posted in Clinical Trials, Toxicology | Tagged , | Comments Off on Toxicokinetic Tips

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to … Continue reading

Posted in Clinical Trials, Project Management, Regulatory Strategy | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off on Project Management for Biotech Companies

New FDA Guidances – September 2011

Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading

Posted in FDA, Regulatory Strategy | Tagged , , , , | Comments Off on New FDA Guidances – September 2011