Strategies for Bound and Non-Extractable Residues in Laboratory Environmental Fate Studies

Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical,
  • November 06, 2014

Once chemicals enter soil or sediments environments—whether purposefully through application or accidentally in spills or other means—they are subject to a variety of chemical and biological transformations such as photolysis, hydrolysis, volatilization, mineralization, and generation of metabolites and degradants, each with its own significance in assessing environmental risks.

Another important pathway is the formation of bound or non-extractable residues (NER). There has been a long-standing debate on whether bound residues represent an environmental risk in their potential accumulation and persistence, a benefit as a route of removal and detoxification, or both. What’s certain is that the process of bound residue formation is complex and not completely understood.

The characterization of bound residues and NER play an important role in laboratory environmental fate studies conducted for scientific interest and to satisfy regulatory requirements. In this webinar, attendees will learn definitions for bound residues and NER, explanations for their formation, regulatory approaches and guidance, and review case studies of experimental approaches and analytical techniques employed to answer both scientific and regulatory questions.

Speakers

James Schmidt, Senior Scientific Advisor, ABC Laboratories

James Schmidt brings to ABC nearly three decades of experience in xenobiotic metabolism and bio-analytical chemistry with private, government, and industrial laboratories. His expertise lies in the intersection of experimental and analytical science, with special interests in agrochemical environmental fate and metabolism, chiral separation, and metabolite profiling. He is the author or co-author of several peer-reviewed posters and papers, as well as innumerable scientific reports to satisfy regulatory requirements of both the EPA and FDA. Prior to rejoining ABC six months ago, James held positions with the USEPA’s Kerr Groundwater Research Laboratory, Sandoz Agro and various positions in the Pharmaceutical industry. He began his career as a study director and group leader in the Environmental Fate group at ABC, with particular experience in soil and aquatic metabolism studies.

Who Should Attend?

  • VP/Director/Manager of Research and Development
  • VP/Director/Manager of Product Development
  • VP/Director/Manager of Technical Operations
  • Anyone involved in the conduct or oversight of laboratory environmental fate studies

Xtalks Partners

ABC Laboratories

Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the Pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

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