Designing a Comprehensive Self-Administration Drug Abuse Liability Study | Part 2

Series Introduction

Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team at Covance designs and setup accurate and valid nonclinical GLP abuse liability assessment study types required by regulatory agencies: self-administration, drug discrimination and physical dependency studies. For the first in this series, we will explore how to design and develop a comprehensive self-administration study to test for a drug’s potential abusive or addictive nature.  

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Meet Me in 5: Growing a Unique Global Internship Program

Our ongoing “Meet Me in 5” series covers 5 people, topics or questions to illustrate how Covance nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, we spoke to Rebecca Verhulst, Associate Director, Global University Relations, to learn the history of the internship program at Covance, its value to the business and what the program means for interns looking to gain exposure in a global organization.

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Pharmacovigilance & Risk Management for Biosimilars: Unique Challenges & Possible Solutions

This post originally appeared on the blog of Sciformix, a Covance company.

Original Author: Suhasini Sharma 
Director, Medical Affairs

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.

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LabCorp Expands Drug Development Solutions with Acquisition of Sciformix

This post originally appeared on the blog of Sciformix, a Covance company.

Sciformix extends Covance’s pharmacovigilance capabilities for post-approval safety solutions
BURLINGTON, N.C.–(BUSINESS WIRE)–Jun. 11, 2018– LabCorp® (NYSE: LH), a leading global life sciences company, announced today that it has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients. Sciformix will become part of Covance, LabCorp’s drug development business.

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Our Polypharmacy State: Understanding Drug-Drug Interactions (DDIs) in the Drug Development Process

In 2018 the FDA and several other regulatory bodies are expected to enact and enforce more laws related to the requirements for nonclinical drug-drug interaction (DDI) studies prior to an IND. A key component of developing a drug for market-use is to test for how it might interact with other drugs or substances in the body.

Here’s an overview of what a DDI is and how it effects the drug development process.

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Technology & Automation Drive Operational Efficiencies Across the PV Continuum

This post originally appeared on the blog of Sciformix, a Covance company.

Original Author: Susan Najjar, Director, Marketing

We are all aware that what we know of Pharmacovigilance today will radically transform in the future with the use of automation and technology tools. Companies that implement these tools in their PV operations can experience greatly improved efficiency, compliance and quality.

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