Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

EMA extends real-time release testing role in new guidelines

Posted on | April 17, 2012 | No Comments

The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products…
http://www.in-pharmatechnologist.com/Processing-QC/EMA-extends-real-time-release-testing-role-in-new-guidelines

Chairman of top EU drugs committee quits

Posted on | April 6, 2012 | Comments Off

“The chairman of the European Medicines Agency’s main committee for approving new drugs resigned on Wednesday after his position at the French healthcare regulator AFSSAPS was eliminated. Eric Abadie’s resignation as chairman of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) took effect immediately…more

GlaxoSmithKline to raise average UK salaries by 4%

Posted on | March 15, 2012 | Comments Off

In a sign that the economy is recovering…”GlaxoSmithKline (GSK) will raise its UK employees’ average salaries by around 4% in 2012. In the GSK annual report 2011, published on 12 March, the pharmaceutical firm also said it will raise average US employees’ salaries by …more

Spring 2012 ACS National Exposition

Posted on | March 1, 2012 | Comments Off

It looks like I’ll be in Europe while this one is going on. This looks like a great Expo. Oh well, next time…

San Diego Convention Center
Dates: March 25-29, 2012
Location: San Diego, California, USA
Theme: Chemistry of Life

ACS’ 243rd National Meeting & Exposition will host more than 11,700 presentations on new discoveries that span science’s horizons — from astronomy to zoology. Topics include:
•Food and nutrition
•Medicine
•Health
•Energy
•The environment
•Other fields where chemistry plays a central role in preventing and combating disease

More Info…

Trade secret changes critical to regulatory sharing, FDA says

Posted on | February 15, 2012 | Comments Off

“The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators…more”

“Trade secrets include such things as a company’s manufacturing processes and precise product formulations. The Task Force believes that trade secrets have limited value for public disclosure, and that the value for public disclosure of other types of data, such as clinical trial results and adverse event reports, is significantly greater…more

FDA biosimilar guidance permits alternative drug delivery devices

Posted on | February 14, 2012 | Comments Off

“The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance… more

According to Wikipedia… “Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products can have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. Consequently only a few subsequent versions of biologics have been authorized in the US through the simplified procedures allowed for small molecule generics, namely Menotropins (January 1997) and Enoxaparin (July 2010), and a further eight biologics through the 505(b)(2) pathway”

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