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 [...]

By |January 13th, 2016|Categories: Blog|

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 [...]

By |December 14th, 2015|Categories: Blog, Homepage Featured|

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 [...]

By |December 10th, 2015|Categories: Blog|

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 [...]

By |December 1st, 2015|Categories: Blog, Homepage Featured|

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 [...]

By |November 16th, 2015|Categories: Blog|