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WHITE PAPERS

Worldwide Clinical Trials Ltd

phone ++1 610-632-8190
web http://https://www.worldwide.com/
email 3800 Paramount Parkway, Suite 400, Morrisville, NC 27560

Technology Solutions - Driving efficiencies, quality and operational excellence

Clinical trials involve the entry, analysis and reporting of millions of pieces of data; year-on-year, the amount of data required to manage efficacy and safety increases exponentially. Recently, solutions available to support this activity have grown in numbers and complexity. The rise of Tablets and Smart Phones combined with the growth of Cloud or SAS solutions has resulted in the technology landscape required to support complex, global studies becoming more confusing.
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News and Press Releases

U.S. Alliance Pharma Acquires U.K.-based LGC’s Drug Development Solutions (DDS) Business

Expands bioanalytical services to include many emerging areas worldwide.
More info >>


White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>



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