Drug Development

Articles

Orally disintegrating tablets (ODTs) are growing in popularity and their market value could exceed $13 billion in sales by 2015, based on current global growth trends.

The Growth Of ODTs

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.

An Update On The EU's Plans For Excipient Regulation

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Using Excipients With Biologics

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Is There A Need For Stringent Regulations For Excipients?

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

Week of Jan. 3, 2011: Company and People Notes: Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an "unprecedented" shortage of prescription drugs, especially for chemotherapy.

Senator to Draft Legislation to Mitigate Drug Shortages

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Contract manufacturers strengthen their toolboxes and partnerships as they navigate the changing drug-development model.

Exploring Custom Synthesis

Sean Milmo is a freelance writer based in Essex, UK.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Report from Europe

Expert and implementation working groups harmonize more guidelines and move Q11 forward.

Inside ICH: ICH Meets in Japan to Finalize Key Documents

The authors discuss the role of quality-control automation in providing better data, enhanced compliance, and potentially faster release times.

Ingredients