October 29, 2009
By:Travis Emig
With the global economy in a recession, a vast majority of pharmaceutical companies are being forced to cut costs and control spending. For most companies this means a reduction in workforce and tighter outsourcing budgets. Companies are left with the same amount of required laboratory testing, but with fewer employees to perform the work in-house. Clients are left searching for value-added programs that will allow them to project all of their outsourcing costs for an entire year in order to lock in on set annual costs.
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October 29, 2009
By:Nathan T. Whitford
The USP General Chapter <467> on Residual Solvents became effective on July 1, 2008. Alternate methods may need to be developed and validated for compounds and any other unlisted solvents used in manufacturing that cannot be tested by the General Chapter's GC method. Lancaster Laboratories' analysts have been utilizing a technique referred to as a self-validating method. The benefit to this self-validating method approach includes a faster timeline and is more cost effective than the traditional approach for clients having a short term or infrequent need for testing.
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October 21, 2009
By:Lancaster Laboratories
Lancaster Laboratories' Professional Scientific StaffingSM service has been specifically designed to give you the "non-permanent" workforce you need for anywhere from one year to 10 years or more with no worries about co-employment and at lower costs than fixed headcounts.
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October 5, 2009
By:Wayne Vallee, R.Ph., MBA, RAC
Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only a small fraction of the drugs marketed and used as therapies in the United States have been studied in pediatric patients 0–16 years of age. Recent data demonstrates that only about 25% of approved drugs marketed in the United States have adequate pediatric data to support approval of product labeling by FDA for dosing, safety, or efficacy in children. This lack of appropriate pediatric testing and labeling increases the chances of incorrect dosing, thereby exposing pediatric patients to either an increased risk of adverse reactions or less than optimal therapeutic benefits.
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October 5, 2009
By:Debra Norman, Ph.D., JD, Gary Hindman, Ph.D.
On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; "the Act") took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation.
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October 5, 2009
By:Richard Angelo, Ph.D.
The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline.
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September 21, 2009
By:Tom Hughes
Clearly defined objectives and project requirements between the pharmaceutical company and their contract packager need to be spelled out ? in writing ? in a Technical Transfer Document prior to any pharma packaging project. A published report documenting details for the customer and the packager is a critical component for success.
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September 14, 2009
By:Tim Freeman
For those seeking to adopt a Quality by Design approach to pharmaceutical development and manufacture, effective definition of the 'design space' is a key activity. This paper considers the role of modern powder testers such as the FT4 from Freeman Technology, within this context.
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September 1, 2009
Part one of the three?part core technology white paper series discusses the principle of operations of capillary thermal and immersible thermal gas mass flow measurement technologies. Taken together, these two methods cover a wide spectrum of gas mass flow measurements typically found in industrial applications.
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Processing & Packaging Online Auction - October 27, 200p, 9-4ET.
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Buy new and used pharmaceutical equipment, used process equipment and laboratory equipment at LabX. Auctions, classifieds, and post FREE wanted ads to locate equipment.
Join over 10,000 Process Industries professionals at the single best resource for new products, new ideas and new technologies, The New CHEM SHOW at New York's Javits Convention Center, November 17-19, 2009.