Articles
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Track And Trace In China
2/9/2012
Track and trace technology has significant value for both industry and society. Both Chinese industry and the government are increasing efforts to promote the establishment of a reliable, safe traceability system. By Yuxiang Zhang
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Brochure: Pharma Sterile Dosage Forms
1/30/2012
DSM offers pharmaceutical and biopharmaceutical customers a lyophilization system with unique benefits. It has the precision to serve increasingly demanding lyophilization cycles, a critical requirement for successful product launches and high commercial yields.
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Preparation Of MUPS (Multiple Unit Particles System) Tablet Using Celphere™ And Preliminary Blend Of Microcrystalline Cellulose And Pregelatinized Starch
12/2/2011
Multiple dosage forms (Pellets, Capsule, MUPS tablet etc.) show better reproducibility of the drug absorption in the body than single dosage form (Matrix tablet).
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The Case For The Use Of Point-Of-Care Testing In Pharmaceutical Clinical Trials
11/22/2011
Clinical trials that are designed to evaluate the efficacy of novel pharmaceuticals require a variety of diagnostic tests to be performed on all enrolled patients.
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Greg Weilersbacher's Expert Advice On Selecting A CMO
11/11/2011
Life Science Leader magazine put together an executive roundtable article on the CMO selection process for a 2011 special supplement. The intent — to gain a better understanding of the some of the challenges faced during the partnering and provide insights on how to overcome. By Rob Wright
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White Paper: Clinical Trial Material Production And Testing: What Your CMO Is Not Telling You
6/7/2011
Manufacturing clinical trial material (CTM), and the costs for the associated fill/finish and release work, most likely are not the costliest portions of the pharmaceutical process chain. By Alexander Mello, Director, Project Management
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White Paper: Pharmaceutical Sterility Testing — Essential Things You Must Know
6/7/2011
Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. An understanding of sterility testing is beneficial in terms of designing a validation process. By Steven G. Richter, Ph.D
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Case Study: Flu Vaccine Trial Accelerated Despite Late-In-Season Start
5/11/2011
Streamlined processes for study startup, coupled with experience in vaccine trials and solid relationships with study sites and investigators, helped this Quintiles team meet the challenge of starting an influenza vaccine trial late in the influenza season.
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Targeting Oncology
5/11/2011
In the search to improve cancer outcomes, each promising advance across the biopharmaceutical frontier comes with challenges as unique as the specific molecular pathway and individual genetic profile it targets.
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White Paper: FDA Requirements For Clinical Studies In Pediatric Patients
5/11/2011
FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy and safety in children.