The Lancet Calls For Review Of Regulatory Process Of Drug Trials

by Medindia Content Team on  April 15, 2006 at 8:53 PM Drug News
RSS Email Print This Page Comment
Font : A-A+

The Lancet Calls For Review Of Regulatory Process Of Drug Trials
The medical journal Lancet has called for immediate changes in the approval processes and regulation of human trials of biological drugs. This call came after the trial of TGN1412 ended in disaster with six patients admitted in the hospital in serious condition.

The journal says that since the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorized the trial, it is the agency's responsibility to review the protocol. However there was no fault with the quality of the test drug, no contamination,
no dosing error, yet the trial went wrong. "The TGN1412 events indicate urgent change is needed in the... regulation of phase I trials of biological agents," the journal said. The report stresses that regulatory agencies must take into account predicting toxicity of activating antibodies compared with conventional small molecule drugs.

Post a Comment

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
Notify me when reply is posted
I agree to the terms and conditions

More News on:

Drug Toxicity Clinical Trials Clinical Trials - The Past and The Future Clinical Trials - Different Phases of the trial Signature Drug Toxicity 

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Advertisement
Advertisement

Stay Connected

  • Available on the Android Market
  • Available on the App Store

Facebook

News Category

News Archive