Year: 2019
What You Need to Know About Micro-Autoradiography (mARG) Distribution Studies
- In Vivo & Radiolabeling
- December 19, 2019
- Jolanta Golec, Madison Esely-Kohlman
In vivo determination of drug localization in tissue can be uniquely informative to drug developers investigating distribution within the context of...
What In Vitro Metabolism and DDI Studies Do I Actually Need?
- Regulatory Guidance
- November 25, 2019
- Madison Esely-Kohlman, Greg Loewen
Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...
DDSC In Vivo ADME Expertise Providing Cost Savings
- Updated Offerings
- November 19, 2019
- Scott Hickman
ADME studies are a vital part of the drug development process, and therefore, deciding where and how to perform these studies...
Mass Balance Studies: What You Need and Why You Need It
- In Vivo & Radiolabeling
- November 15, 2019
- Jolanta Golec, Madison Esely-Kohlman
In vivo mass balance studies are an important element of nonclinical drug development, to inform first in-human (FIH) studies and to...
I Have My Data… Now What?
- Consultancy
- October 16, 2019
- Madison Esely-Kohlman
As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...
The FDA has requested follow-up data… how do I fill in the gaps?
- Regulatory Guidance
- October 9, 2019
- Madison Esely-Kohlman
Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...
Why You Need QWBA for Human Radiolabeled ADME Studies
- Regulatory Guidance
- October 4, 2019
- Satoshi Ito
A quantitative whole body autoradiography (QWBA) study provides data required for Human Radiolabeled ADME Studies1. Quantitative whole body autoradiography (QWBA) is an in...
XenoTech Named Best In Vitro Drug CRO 2019
- Updated Offerings
- September 19, 2019
- Michael Millhollen
XenoTech has been named the Best In Vitro Drug CRO in the 2019 Healthcare & Pharmaceutical Awards. From the release:...
How to Choose the Right Test Systems for Your DMPK Studies
- Test Systems & Methods
- September 12, 2019
- Dr. Chris Bohl, Madison Esely-Kohlman
Test systems for DMPK in vitro studies are part of the very foundation of our company. Our labs were borne of...
XenoTech Named a 2019 Top-Performing Provider on Science Exchange
- Updated Offerings
- September 4, 2019
- Michael Millhollen
Science Exchange stated, “Discovery research programs at growing biotech companies are demanding—R&D leaders must balance the need to innovate with...
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