Tag Archive: stability

Jan 30 2013

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Oct 05 2012

New FDA Guidances from September 2012

There were only a few guidances released by FDA in September 2012: Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Complicated Intra-Abdominal Infections: Developing Drugs for Treatment  Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with …

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Nov 02 2011

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

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