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Talking R&D

Showing 6 posts of 6 posts found.

Talking R&D: eCTD challenges

October 6, 2010
Manufacturing 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, …

Feature

Talking R&D: Evolving technical standards

October 5, 2010
Manufacturing 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 …

Feature

Talking R&D: US regulatory guidelines

October 4, 2010
Manufacturing 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 …

Feature

Talking R&D: Strategic vs full service CRO

September 1, 2010
Research 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 …

Feature

Talking Point: Responding to trial emergencies

March 19, 2010
Research 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 …

Feature
Xceleron's Dr Graham Lappin

Talking R&D: Microdosing studies

January 18, 2010
Research 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 …

Feature
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