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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

Selecting an Animal Model for Safety Testing of Women’s Health Treatments

Selecting the appropriate animal model for testing the safety of women’s health therapies, such as intravaginal rings and gels, is crucial for the successful development of the therapy.  While nonhuman primates are physiologically the most similar to humans, and therefore advantageous for late-stage evaluation of efficacy, there are several other animal model options suitable for […]

By | 2017-07-04T10:27:04+00:00 August 28th, 2015|Blog|Comments Off on Selecting an Animal Model for Safety Testing of Women’s Health Treatments

How to Save Your Development Dollars and be Smart with Your Bioanalytical Studies

by Roger Hayes, PhD

There’s an old saying in the marketplace: “You can have it quick, cheap or good. Pick two.”

In bioanalytical testing, some will argue that, given the complexity of new chemical entities, it’s impossible to make that choice.  And I agree, but only because you don’t have to. I believe you can have all […]

By | 2017-07-04T10:27:12+00:00 June 3rd, 2015|Blog|Comments Off on How to Save Your Development Dollars and be Smart with Your Bioanalytical Studies

Micro-CT: ‘Little Brother,’ Big Results

by Shane Woods, Senior Study Director

The younger sibling of a medical innovation is bringing big value to the research laboratory. Micro-computed tomography, also known as micro-CT or mCT, delivers exceptionally high- resolution microscopic images of tiny biological samples, helping scientists better understand the effects of emerging medical treatments.

The story of micro-CT begins in the 1970s. […]

By | 2017-07-04T10:27:12+00:00 April 8th, 2015|Blog|Comments Off on Micro-CT: ‘Little Brother,’ Big Results

Surgical and Orthopaedic Insights from Biomechanical Testing

by Shane Woods, Senior Study Director

As surgical procedures advance and treatments become more sophisticated, the need to understand how they affect the body matures. That’s where biomechanical testing can provide keen insights.

Biomechanics combines engineering with biology to help us better understand the complexities of life.  Evaluating bone, cartilage, muscle, tendon and other tissues—how they respond […]

By | 2017-07-04T10:27:16+00:00 April 1st, 2015|Blog|Comments Off on Surgical and Orthopaedic Insights from Biomechanical Testing

What is SEND? A Brief Introduction to the Standard for Exchange of Nonclinical Data

By Christy Kubin, BS, Data Architect (SEND), Brian Argo, BS, Data Architect (SEND), and Jamie Megna, BS, Data Architect (SEND)

SEND is the Clinical Data Interchange Standards Consortium (CDISC), Standard for Exchange of Nonclinical Data (SEND). It is an implementation of the Study Data Tabulation Model (SDTM) for nonclinical studies. This description […]

By | 2017-07-04T10:27:21+00:00 March 18th, 2015|Blog|Comments Off on What is SEND? A Brief Introduction to the Standard for Exchange of Nonclinical Data

Why do Preclinical Humane Endpoints Matter?

by Dale M. Cooper, DVM, MS, DACLAM

When people are suffering or dying from disease, there’s a powerful incentive to move new treatments through the pipeline as quickly as possible. But while speed is important, it cannot come at the expense of quality and compliance.  The care of animals involved in preclinical safety studies is a […]

By | 2017-07-04T10:27:22+00:00 March 11th, 2015|Blog|Comments Off on Why do Preclinical Humane Endpoints Matter?

Making The Most of Biomarkers in Preclinical Studies

by Adam Aulbach, DVM, DACVP

Biomarkers are a useful tool in clinical trials, especially in identifying a drug’s impact on organs or tissues before any injury is clinically evident. It’s still early in their use in preclinical development; however, they are proving helpful in identifying major safety issues and showing promise for future use.

Presently, biomarkers are […]

By | 2017-07-04T10:27:23+00:00 February 25th, 2015|Blog|Comments Off on Making The Most of Biomarkers in Preclinical Studies

The Connection between Inflammation and Cardiovascular Disease

by Mark Johnson, M.S. Senior Director of Surgery

Heart disease is a major cause of morbidity and mortality, particularly in developed nations. Classically, cardiovascular disease (CVD) was thought to be a buildup of fat on the arterial wall that eventually blocks blood flow, leading to a heart attack or stroke. However, the process also involves inflammatory […]

By | 2017-07-04T10:27:23+00:00 February 18th, 2015|Blog|Comments Off on The Connection between Inflammation and Cardiovascular Disease

The Role of Swine as Preclinical Models for Cardiovascular Disease

by Mark Johnson, M.S. Senior Director of Surgery

Classically, pharma, biotech, and device researchers have relied on rodent models to discover and validate disease targets and mechanisms, as well as for the preclinical development of therapeutics. However, the biology of rodents often fails to accurately predict outcomes in patients – perhaps not surprisingly, as mice are […]

By | 2017-07-04T10:27:26+00:00 February 11th, 2015|Blog|Comments Off on The Role of Swine as Preclinical Models for Cardiovascular Disease