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Lessons Learned in Preparing Nonclinical Programs Part II:

Species Selection

The basic question that helps to address this is “what is your test article type?”.  For small molecules, invariably there will be two species needed; a rodent and a non-rodent, while for a biopharmaceutical it could be either one species or two species. While there is public pressure to minimize the use of species […]

By | 2017-07-04T10:26:25+00:00 July 9th, 2016|Homepage Featured, Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part II:

Hernia Treatment Evaluation

With more than one million hernia repairs performed each year in the U.S., a hernia is an all-too common condition for many.  A hernia occurs when an organ pushes through an opening in the muscle or tissue that holds it in place. They are most common in the abdomen, when intestines break through a weakened […]

By | 2017-07-04T10:26:40+00:00 April 29th, 2016|Blog, Homepage Featured|Comments Off on Hernia Treatment Evaluation

The Role of Biofilms in Infected Wounds

Anton van Leeuwenhoek (1632-1723) was the first person to delve into the field of microbiology and document initial observations of bacteria. After this preliminary discovery, microbiology was not actively studied again until the 1800s, when it began to gain a foothold in contemporary medicine. Fast-forward to today’s labs, where clinicians are becoming more knowledgeable in […]

By | 2017-07-04T10:26:41+00:00 March 31st, 2016|Blog, Homepage Featured|Comments Off on The Role of Biofilms in Infected Wounds

What is affecting your sample preparation and potency measures?

by Ashley Sanchez, BS, Senior Project Manager, Analytical Sciences

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications. Potency determinations are made using a validated analytical method. We have identified […]

By | 2017-07-04T10:26:43+00:00 December 14th, 2015|Blog, Homepage Featured|Comments Off on What is affecting your sample preparation and potency measures?

Is Preclinical Dose Formulation Stability Analysis Important?

by Roger Hayes, PhD, Senior Vice President and General Manager of Laboratory Sciences

The answer is yes! Establishing adequate stability of a preclinical dose formulation is a critical component in drug development, as it ensures that the test system receives the appropriate amount of test article based on protocol specifications. Considerations for designing adequate stability protocols must […]

By | 2017-07-04T10:26:53+00:00 December 1st, 2015|Blog, Homepage Featured|Comments Off on Is Preclinical Dose Formulation Stability Analysis Important?

Emerging Trends in Therapies and Medical Devices for Women’s Health

Over the past 20 years, few clinical areas have experienced faster growth than that of women’s health. In 1994, the FDA committed to a greater focus on women’s health with the establishment of the Office of Women’s Health (OWH), created to improve understanding and advance the treatment of women’s health issues.  Since then, the study […]

By | 2017-07-04T10:27:04+00:00 September 10th, 2015|Blog, Homepage Featured|Comments Off on Emerging Trends in Therapies and Medical Devices for Women’s Health