The Pharmaceutical Journal
Vol 279 No 7467 p224
1 September 2007

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Phase I trial guidance published by industry

New guidelines for phase I clinical trials have been published by the Association of the British Pharmaceutical Industry.

The key recommendations from a Government-commissioned report into the TGN1412 trial at Northwick Park (PJ, 16 December 2006, p727) have been incorporated into the guidelines. Richard Barker, director-general of the ABPI, commented: “While the events surrounding the TGN1412 trial were unprecedented, we nevertheless have to do everything to ensure they never occur again.”

In terms of pharmacy involvement in phase I trials, the guidelines recommend that (compared with later stages of development) the protocol for a phase I trial should emphasise any pharmacy work needed to prepare doses for administration. It also sets out the premises, facilities, equipment, storage and staff requirements of the pharmacy being used for the trial.

The guidelines are available online