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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

Top Four Analysis Considerations for Antibody Drug Conjugates (ADCs)

Roger Hayes, PhD, Senior Vice President, General Manager, Laboratory Sciences

Chemotherapy is a mainstay of a standardized treatment regimen for cancer. However, the nonspecific targeting of healthy cells as well as tumor cells by cytotoxic small molecule drugs often results in intolerable side effects. These side effects compromise the efficacy of the treatment regimen and dramatically […]

By | 2017-07-04T10:26:42+00:00 January 13th, 2016|Blog|Comments Off on Top Four Analysis Considerations for Antibody Drug Conjugates (ADCs)

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?

A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

Jamie Megna, SEND Data Architect
Christy Kubin, SEND Data Architect

We recently participated in the October Standard for Exchange of Nonclinical Data (SEND) Face-to-Face meeting between the FDA and industry. We want to share with you our take-a-ways on the latest SEND developments from this productive session. The FDA is encouraging the industry to submit sample SEND […]

By | 2017-07-04T10:26:48+00:00 December 10th, 2015|Blog|Comments Off on A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

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?

The Importance of Bioanalytical Method Range Identification and Time Point Selection in Pharmacokinetic (PK) Studies

Clint Rosenfeld, PhD, Senior Director, DMPK
Jocelyn Mielke, BA, LAT, Associate Kinetic Scientist

When transitioning from lead optimization to development, there are several factors that should be understood prior to conducting GLP toxicity studies. These include performing a gap analysis which involves identifying the bioanalytical method ranges and selecting appropriate collection intervals to accurately quantify systemic […]

By | 2017-07-04T10:26:57+00:00 November 16th, 2015|Blog|Comments Off on The Importance of Bioanalytical Method Range Identification and Time Point Selection in Pharmacokinetic (PK) Studies

Conducting a Pharmacokinetic Gap Analysis

Clint Rosenfeld, PhD, Senior Director, DMPK
Jocelyn Mielke, BA, LAT, Associate Kinetic Scientist

If you have completed pharmacokinetic (PK) screening and the lead optimization process, and you think you’re ready to take your molecule through the drug development process, there are several factors that need to be considered. Certain fundamental questions should be answered to address some […]

By | 2017-07-04T10:26:59+00:00 November 2nd, 2015|Blog|Comments Off on Conducting a Pharmacokinetic Gap Analysis

Drug Development: When did it become so hard?

by Roger Hayes, Senior Vice President and General Manager, Laboratory Sciences, MPI Research

In today’s world of drug development, almost every aspect of the development continuum is related to speed, efficiency, precision, and quality. Whether it is a generic company racing to first-to-file status, a virtual or biotech company looking to entice Sponsors with promising data, […]

By | 2017-07-04T10:27:02+00:00 October 19th, 2015|Blog|Comments Off on Drug Development: When did it become so hard?

Saving Our Troops: An Efficacy Model for Platelet Replacement Products

The best way to support our troops is to help them come home healthy. Over 52,280 United States service members were wounded in action during the conflicts in Iraq and Afghanistan (Congressional Research Service[1]).  Many of these injuries were associated with blood loss. To prevent excessive blood loss, researchers are developing novel platelet replacement products.

By | 2017-07-04T10:27:03+00:00 October 1st, 2015|Blog|Comments Off on Saving Our Troops: An Efficacy Model for Platelet Replacement Products