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Pace Analytical Life Sciences, LLC Method development & validation, stability testing and storage, raw material testing, compendial testing, release testing, drug/device combination product testing, microbiology testing, extractables/leachables testing,...

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Cetero Research Cetero Research is an industry leading CRO in clinical pharmacology, bioanalytical, and specialty Phase II-IV services. With more than 25 years of experience from our founding companies, we have conducted more clinical...

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Quantachrome Instruments Surface area analyzers, pore size analyzers, pycnometers, TPR, TPO, TPD, water vapor sorption, DVS, particle size distribution

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Covance Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance...

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ACM Global Central Laboratory Central Lab Services, Clinical Trial Services - ACM Global Central Lab

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Lancaster Laboratories Lancaster Laboratories is the trusted leader in biopharmaceutical and pharmaceutical laboratory services and scientific solutions.

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Columbia Analytical Services Columbia Analytical Services, Inc. is a full-service analytical laboratory testing network established in 1986 and headquartered in Kelso, Washington. With locations across the United States, Columbia Analytical exceeds...

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Lancaster Laboratories	Analytical Strategies for Monitoring Residual Impurities Encountered In ... Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor ...

Lancaster Laboratories	Lancaster Labs offers Melamine testing In August 2009 the Food and Drug Administration released a guidance for industry titled, Pharmaceutical Components at Risk for Melamine Contamination. The document, identifying various raw materials that are considered high risk for melamine contamination, recommends monitoring of these raw materials for the presence of melamine prior to release into production. The FDA also provided links to ...

Lancaster Laboratories	Raw Materials Express Testing At no additional cost to clients, Lancaster Laboratories streamlines Raw Materials testing expressly for certain routine USP and EP tests. Have results in 5 days if compendia methodology and noncustomized documentation formats suit your project needs. And with LabAccess.com, our 24/7 web portal, view all your data such as analysts' notebooks, chromatograms, and individual test results as your ...

Lancaster Laboratories	Residual Solvents: Alternate Validated Methods Since the USP General Chapter <467> on Residual Solvents became effective on July 1, 2008, Lancaster Laboratories has seen a multitude of requests for many different solvent and sample matrix combinations. The new General Chapter applies to both monographed and non-monographed items, including all drug substances, excipients, and products “subject to relevant controls.” So a number of ...

Covance	Analytical Considerations in Formulation Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success. A biopharmaceutical formulation consists of active pharmaceutical ...

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Analytical Laboratory Services Research Library

Pace Analytical Life Sciences, LLC	Analytical Laboratory outsourcing with quality

Quantachrome Instruments	DVS Water Vapor Sorption on Milk Powder (lactose) Material Category: Food Method Category: Water vapor sorption Instrument Category: Aquadyne DVS Milk powder is a valuable commodity for industrialized and third world countries. It is widely used in industrialized countries as the basis for powdered infant foods and by the baking and confection industries as a raw ingredient. In developing countries, especially those hit by famines, milk powder ...

Covance	Clearing the Air: Critical Consideration in Inhalation Toxicology The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the ...

ACM Global Central Laboratory	Nephrotoxicity Testing in Clinical Trials to Improve Patient Safety The incidence of drug-induced nephrotoxicity is unknown but is generally considered to be high. Kleinknecht et al. (1987)1 suggested that the incidence of kidney damage due to antibiotics has been reported to be up to 36%, much of which is fortunately reversible. The range of pharmaceutical drugs shown to be nephrotoxic in some individuals is extensive. This is hardly a surprise as 25% of ...

Lancaster Laboratories	Lancaster Labs develops extractables/leachables database The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. ...

Analytical Laboratory Services Video

Quantachrome Instruments	Quantachrome Instruments Video The Zeta-Reader: Watch just how easy this rapid zeta potential analyzer is to use. Instructional, educational.

Wolfe Laboratories, Inc.	Wolfe Laboratories on Personalized Medicine Trends Greg Gumbel reviews the modern global economy and personalized Medicine Trends. Featured in video is Janet Wolfe Founder and President of Wolfe ...

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