Tag Archive: toxicology

Dec 21

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 risk of neural tube birth defects and fortification of milk with vitamin D that has …

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Dec 09

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 leaf moving – quite figuratively), provide nutrition and food sources, and have been historically used …

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Jun 05

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 TK is simply PK performed within a toxicology study. However, a major difference between the …

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Nov 02

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 lag behind and often do not recognize that project management is not too complex or …

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Oct 14

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 and Biological Products De Novo Classification Process (Evaluation of Automatic Class III Designation) (Draft) Self-Selection …

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Sep 19

FDA Reorganizes Oncology and Hematology Divisions

When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office of Oncology Drug Products into a new office: The Office of Hematology and Oncology Products …

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May 27

Bridging the Valley of Death: Bringing New Drugs from the Bench to the Clinic

Bridge

To bring a new medicine to the stage of clinical trial testing requires on the order of $500,000 to one million dollars and then seven to ten years of clinical trials and around $800 million dollars before getting to market.  However, it is doable, and one can point to successful biotechs such as Genentech, Amgen, …

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May 09

Conference Recap – 2011 Society of Toxicology Annual Meeting

The Society of Toxicology’s (SOT) 50th Anniversary Annual Meeting was held on 05-10 March 2011 in Washington, DC.  Several members of Cato Research’s Nonclinical Sciences Development group were amongst the more than 7,000 toxicologists from 50 countries in attendance this year.  The five-day event provided scientists with countless opportunities to discuss the latest scientific achievements …

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Mar 10

Therapeutics for Rare and Neglected Diseases – How Rare is Rare?

The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States.  As insignificant as this classification may sound, collectively there are more than 25 million people in the United States affected by approximately 6,800 rare diseases. These rare diseases are alarmingly overlooked and under researched. …

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Feb 17

New Book – Principles of Anticancer Drug Development

Recently, Humana Press/Springer published a new book, Principles of Anticancer Drug Development. Neil Clendeninn M.D., Ph.D., a Senior Clinical Research Physician for Cato Research, served as an editor for the book, which has been described as a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

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