- March 4, 2013 | BY
The harmonization of regulatory guidance for drug development traces its origins to the European Community (EC) in the mid 1980’s. The current governing body of record, known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), was formed in 1990 at a joint meeting of regulatory agencies ...
- February 25, 2013 | BY
When I hear the word anticipation, I can’t help but think of the first line in the song with the same title that Carly Simon made famous in the 1970’s: “We can never know about the days to come.”
That is where we are with the long-anticipated modernization of the Food and Drug Administration (FDA) Good ...
- February 19, 2013 | BY
Historically, advances in immunology have been closely associated with studies of infectious diseases. However, in the past 10 years, immunology has moved from identifying and characterizing individual molecules and cell types to understanding the roles of each, and the regulatory networks that govern interactions between immune cells.
This increased understanding has led to the elucidation of ...
- February 11, 2013 | BY
For decades, the requirements for determining the toxicological profile of a new chemical entity (NCE) through a safety assessment study were well-defined. But advances in research brought about novel entities, bringing new challenges to toxicology testing.
Biopharmaceuticals introduced many of these challenges in the 1980s. Half-lives for these larger molecules were measured in days, not minutes ...
- February 4, 2013 | BY
Toxicologic pathology integrates the disciplines of toxicology and pathology . Those who practice in this field identify the effects of test articles (e.g., drugs, chemicals and other therapeutic devices) on research models.
The data generated are a critical component of the safety assessment process and can be used to predict responses in humans and other animals ...
- January 29, 2013 | BY
This month’s series of articles has focused on the worldwide prevalence of obesity and how it increases the risk for metabolic and respiratory diseases. The underpinning across all of these disorders appears to be activation of the immune system.
It’s well-established that autoimmunity is important in the development of Type 1 diabetes (T1D) in humans, ...
- January 21, 2013 | BY
There is concern now that overweight children have increased odds of getting asthma as well as having a higher severity of the disease.
- January 14, 2013 | BY
Two primary models are used to study obesity, the monogenic and polygenic.
- January 8, 2013 | BY
Two of the most fundamental requirements to our survival are the ability to survive periods of starvation and the capacity to mount an effective response against pathogenic invaders.
- January 2, 2013 | BY
In 1991 there were four states in the United States where 15-19% of the population was obese. When the CDC revised the stats in 2010, every state had an obesity rate over 20%.