HORSHAM, Pa., April 27, 2016 /PRNewswire/ -- Experts from DrugScan®, PinneyAssociatessm, and INC Research® announced today that they will host a live, complimentary webinar titled, "Understanding the FDA's Abuse-Deterrent Guidance for Innovator and Generic Opioids - The Evolving Pathway for Development and Labeling", on Wednesday, May 25, 2016 from 12:00 PM to 1:00 PM EDT.
Featured speakers include:
- Anthony Costantino, Ph.D., CEO, DrugScan. Tony is a former President of the Society of Forensic Toxicologists, Inc. (SOFT) and a Diplomat of the American Board of Forensic Toxicology (ABFT). DrugScan is a leader in conducting laboratory-based manipulation and extraction studies.
- Edward Cone, Ph.D., Principal Scientist, Drug Delivery and Abuse-Deterrent Drug Products, PinneyAssociates. Ed brings decades of expertise in chemistry, pharmacology and the design and execution of Category 1 in vitro laboratory studies of abuse-deterrent opioids.
- Beatrice Setnik, Ph.D., VP, Clinical Pharmacology Early Phase, INC Research. Beatrice brings many years of expertise in clinical abuse and dependence potential evaluation of CNS drugs and abuse-deterrent opioids.
"The FDA considers development of innovator and generic abuse-deterrent opioids a high public health priority," said Dr. Cone, "It is critical for developers to understand the FDA's current thinking in the approval and labeling of innovator and generic products in the context of simultaneously providing effective pain relief and combating opioid abuse."
- Compare and contrast the FDA's innovator vs generic guidance for abuse-deterrent opioids
- Review best practices for conducting studies to evaluate abuse deterrence
A question and answer segment will follow the presentations.
For more information and to register for the webinar, click here: Registration. Availability will be limited. Please register by Friday, May 20, 2016. The webinar will be recorded and available for on-demand viewing at the DrugScan, PinneyAssociates, and INC Research websites.
DrugScan is a leader in laboratory-based abuse-deterrent studies (CAT.one™), clinical and forensic toxicology, medication monitoring, and drug detection laboratory services. DrugScan has been certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) since 1989 and is accredited by the College of American Pathologists (CAP), ensuring consistently high levels of service, compliance with regulations, and achievement of the highest standards of accuracy, professionalism and responsiveness. To learn more about DrugScan and their CAT.one™ capabilities, please visit www.drugscan.com or call 800-235-4890
PinneyAssociates scientists are leaders in in vitro laboratory assessment and tamper testing of abuse-deterrent drugs and formulations. Through our regular interactions with FDA, we have unique insights into the regulatory expectations of abuse-deterrent evaluations and the implications for FDA approval and labeling. PinneyAssociates helps our pharmaceutical and consumer healthcare clients to reduce their regulatory risk and enhance the commercial value of their life sciences products. For more information, please visit www.pinneyassociates.com or call 301-718-8440.
About INC Research
INC Research is a leading, global full-service clinical research organization (CRO) providing the full range of Phase I to IV clinical development services for the world's pharmaceutical, biotech and medical device industries. As a therapeutically focused CRO, with a Trusted Process® delivery methodology, developing the medicines people need is something we take personally. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, investigative sites and patients to accelerate the delivery of new medicines to market to improve world health. We were ranked "Top CRO to Work With" by sites worldwide in the 2013 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 100 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter@inc_research.
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