Home banner
A-Z Index

Quick way to the find the information that you need...

More button
Register with FRAME

Although you do not need to register, any information you provide will be confidential and used only by FRAME to improve the website

Register button
Account Login
Forgot password?

The Journal


Alternatives to Laboratory Animals - ATLA

Download latest issue button Download back issues button Subscribe to ATLA
Contact Us

Tel icon

Tel: +44 (0)115 9584740

Tel icon

Fax: +44 (0)115 9503570

Make an Enquiry

After TGN1412: the CHMP draft guidelines

Bhogal, N.

Hosptial Pharmacy Europe, 33, 43-44 (2007)

The EU Clinical Trials Directive 2001/20/EC, ­governing the conduct of clinical ­trials for investigational medicinal products (IMPs, defined by Article 1 Directive 2001/83/EC), embraces provisions of the Helsinki ­Declaration and operates alongside guidelines, including the International ­Conference on Harmonization (ICH) Note for ­Guidance on Good Clinical Practice (CPMP/ICH/135/95), to protect the rights, safety and ­wellbeing of trials volunteers. In reality, however, adverse reactions to IMPs are not always anticipated because of ­inherent problems with extrapolating to the clinic information from animal and in vitro ­studies. Indeed, one survey ­suggests that only around 11% of IMPs that progress to clinical ­trials are ever registered, with around half of all drug ­failures due to safety, toxicity or efficacy problems.