spacer
home > white papers > Pandemic respiratory vaccine clinical trials: a departure from business as usual - ICON plc
WHITE PAPERS
logo_ICON_plco.jpg

ICON plc

phone +353 1 291 2883
email info-clinical@iconplc.com
web http://www.iconplc.com
email ICON plc, Headquarters, South County Business Park, Leopardstown, Dublin 18, Ireland

Pandemic respiratory vaccine clinical trials: a departure from business as usual

Around the world, the “V” words are on everyone’s lips: Virus and Vaccines. In response to the urgent need for a vaccine for COVID-19, researchers are, at time of publication, running 500+ clinical trials (and counting) on a number of antivirals, antibodies and vaccines. Promising possibilities range from novel new drugs/vaccines, repurposing treatments currently indicated for HIV, Ebola and malaria, to monoclonal antibodies and immune serum.
Pandemic respiratory vaccine clinical trials: a departure from business as usual
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Kieran Coulton named new Chairman at ChargePoint Technology

ChargePoint Technology, specialists in contained and sterile powder transfer solutions has announced the appointment of Kieran Coulton as Chairman. Coulton is an accomplished leader in automation and manufacturing with a track record of 36 years in the industry. Having previously served as President Global Industry for GE Power Conversion, Kieran brings with him a wealth of experience and an ability to achieve excellent levels of business growth.
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 >>


Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement