Hospital Pharmacist
2007;14:246
September 2007

News summary

Lessons from Northwick Park included in new trials code

Revised guidelines about conducting Phase 1 clinical trials have been published by the Association of the British Pharmaceutical Industry.

The new guidelines take into account key recommendations made by Sir Gordon Duff, chairman of the Commission on Human Medicines, in his report into the TGN1412 trial at Northwick Park last year.

The guidelines describe premises and storage requirements, and say that a pharmacist, ideally with manufacturing experience, should prepare the investigational product. They say that a pharmacist or physician should have overall responsibility for these products.

The guidelines are available online