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July 01, 2011
A technical leader in solid dosage forms Pfizer CentreSource provides analytical, technical, regulatory, developmental, manufacturing and packaging support that spans the specialized realm of highly potent solid oral dose drug products.
June 03, 2011
Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
June 02, 2011
April 01, 2011
The main challenge for tablet manufacturers processing highly potent APIs (HPAPIs) is to protect equipment operators from the inhalation of airborne particles and prevent skin contact with the product during the entire production process: dispensing, granulation, tablet compression, coating and packaging.
January 14, 2011
Dishman is giving a step further in its strategy to manufacture high potency (HiPo) Active Pharmaceutical Ingredients (APIs).
October 02, 2010
A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.
September 15, 2010
US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.
September 01, 2010
The main advantage of outsourcing highly potent API (HPAPI) manufacture is that it eliminates the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain.
August 18, 2010
Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.
September 01, 2009
The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances.