Westbury, NY – BioIVT, a leading provider of biospecimens and related services, today announced that it will host a one-hour webinar entitled: “The New FDA Draft Guidance on In Vitro DDI Studies: How Will It Impact You?” at 11 a.m. ET on Nov. 29. Toxicology experts Dr. Andrew Parkinson, CEO of XPD Consulting, and Dr. Ron Laethem, lead, in vitro services at Qualyst Transporter Solutions, a BioIVT company, will discuss how the guidance has changed and how it will impact drug development strategies.
“Using in vitro studies to evaluate a new drug candidate’s DDI potential is a vital element in the drug development and approval process. If that compound increases or decreases metabolic enzyme or drug transporter expression, it can have a clinically-significant impact on the disposition of other drugs administered at the same time,” said Dr. Christopher Black, senior vice president of ADME-Tox at BioIVT. “BioIVT specializes in developing model systems that can examine in vitro drug-related changes in gene expression and receptor pathways regulating those enzymes and transporters. We are proud to share our knowledge and help our peers to navigate these regulatory changes.”
In October, the US Food and Drug Administration (FDA) updated its 2012 draft guidance entitled “Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” It replaced that document with two draft guidances on DDIs, one focused on in vitro studies and the other on clinical drug interaction studies.
This webinar will cover the new in vitro draft guidance, concentrating on metabolism- and transporter-mediated DDIs. Topics to be discussed include why the changes were made, how they impact the design and interpretation of in vitro studies, and how to design a DDI strategy that will comply with regulatory requirements.
Interested parties can register for this complimentary webinar at https://join.onstreammedia.com/register/25475647/fdaguidance.
BioIVT, formerly known as BioreclamationIVT, is a worldwide provider of biological products to the life sciences and pharmaceutical industries. The company specializes in control and disease-state matrices manufactured from human and animal biological specimens and has recently expanded its offering to include cell processing, target and biomarker validation, ADMET, phenotypic assays to characterize novel therapeutics and the development of clinical assays. As a premier supplier of ADME-toxicology model systems, BioIVT enables scientists and biomedical researchers to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and the effects on disease processes. BioIVT’s reputation for providing exceptional customer service coupled with the highest quality biospecimens and services have made it the first-choice supplier for more than 35 years. For more information, please visit www.bioivt.com or follow the company on Twitter @BiorecIVT.
BioIVT Contact: Courtney Noah, Vice President of Marketing, 516-483-1196
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