ICH Impurity Thresholds are Unrealistic for Antibiotics

By Joanne S. Eglovitch / Email the Author / “The Gold Sheet” January 2012, Vol. 46, No. 1
Word Count: 753 / Article # 08120126006

Executive Summary

EMA's proposal to apply the same ICH impurity limits to antibiotics produced by fermentation and semi-synthetic methods as new drug substances is considered unrealistic, and could result in market withdrawals of these products.

Purchase this Article

$50.00 Buy Now

For $50.00, purchase this 753-word article and receive immediate online access. 100% Satisfaction Guarantee.

View a complete sample article »

Already a Subscriber?

Log in for complete access.

Questions?

Call Toll-Free (800) 332-2181 or +1 (908) 547-2159.

+ Show All | – Hide All

Offers & Events

Topics Covered in this Article

Click a keyword for related articles.
Subjects
Manufacturing
Regulatory
Industries
Biopharmaceuticals
Regions
Europe

Log In

Email Address

Password

Remember Me

Forgot your password?

Don’t Have an Account?

If your employer has a site license, create your account to begin using it. Simply click ‘Create An Account’ button below to register now.

Otherwise, please explore our free content subscriptions.

Create an account

Enter the email address associated with your account and a temporary password will be sent to you.

Email Address

Need help? Contact us at (800) 332-2181, +1 (908) 547-2159, or custcare@elsevier.com

Email Article

* Required field

* To:

For multiple recipients, separate email addresses with a semi-colon.

* Your Name:

* Your Email:

Subject: ICH Impurity Thresholds are Unrealistic for Antibiotics

* Add a personalized message to your email:

Please Note: Only individuals with subscriptions to “The Gold Sheet” will be able to access the full article. All other readers will be directed to the abstract and may purchase the article.

or Cancel