Talking R&D
Talking R&D: eCTD challenges
October 6, 2010Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions
The eCTD was of course developed by the ICH (International Conference on Harmonisation) Expert Working Group to make it easier, …
Talking R&D: Evolving technical standards
October 5, 2010Manufacturing and Production, Research and Development Talking R&D, eCTD, eCTD submissions
The European Union (EU) Module 1 specification works in parallel with the ICH eCTD Specification. It was first introduced in …
Talking R&D: US regulatory guidelines
October 4, 2010Manufacturing and Production, Research and Development Talking R&D, eCTD submissions
Recent speculation surrounding current diabetes drugs and their long term effect on cardiovascular health has heads spinning in the pharmaceutical …
Talking R&D: Strategic vs full service CRO
September 1, 2010Research and Development CRO, Talking Point, Talking R&D
CRF Health’s Greg Jewett and Medpace’s Alita Hassan debate the merits of a strategic or a full service contract research …
Talking Point: Responding to trial emergencies
March 19, 2010Research and Development Talking Point, Talking R&D, research and development
Patients taking part in a clinical trial will sometimes experience a medical emergency, at which point the potential need to …
Talking R&D: Microdosing studies
January 18, 2010Research and Development Microdosing, Talking R&D, Xceleron
A microdose study is performed at an early stage of development in order to obtain preliminary pharmacokinetic or distribution data …
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