About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

The Lancet Calls For Review Of Regulatory Process Of Drug Trials

by Medindia Content Team on April 15, 2006 at 8:53 PM
Font : A-A+

The Lancet Calls For Review Of Regulatory Process Of Drug Trials

Advertisement
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,
Advertisement
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.
Advertisement

Advertisement
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
Advertisement
News Category
What's New on Medindia
Coffee May Help You Fight Endometrial Cancer
Fermented Skin Care
Television Binge-Watching May Boost the Risk of Deadly Blood Clots
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Clinical Trials Clinical Trials - The Past and The Future Clinical Trials - Different Phases of the trial Signature Drug Toxicity 
Recommended Reading
Clinical Trials
Clinical trials are experiments that yield useful information to clinicians if a particular treatmen...
Clinical Trials - Different Phases of the trial
Clinical trials serve as a vital component for improving the treatment of medical conditions as they...
Clinical Trials - The Past and The Future
Many of the drugs that are used today have been discovered by chance or often by mere serendipity...
Drug Toxicity
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a d...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
open close
ASK A DOCTOR ONLINE
I have read and I do accept terms of use - Telemedicine

Advantage Medindia: FREE subscription for 'Personalised Health & Wellness website with consultation' (Value Rs.300/-)