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| Title: |
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Quality by Design in Process Development for Freeze-Dried Parenterals |
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| Presenter(s): |
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Lisa Hardwick, Research Scientist, Baxter Healthcare
Dr.Steven Nail, Sr. Baxter Research Scientist. Baxter Phamaceutical Solutions LLC |
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| Description: |
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We will present a case study to illustrate one approach that includes the essential elements of QbD. |
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| Abstract: |
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View Abstract
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| Times: |
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9/15/2010 -
Sessions are offered at 9 am Eastern Standard (NY)Time and 2 pm
Click Here to Register for Either Session
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| Title: |
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Container Closure Selection for Lyophilized Drug Products |
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| Presenter(s): |
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Eugene T. Polini, III and Ronald L. Mueller, Ph.D., West Pharma |
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| Description: |
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The selection of a primary parenteral package significantly influences the stability of lyophilized drug products. Moisture ingress can cause degradation of those products. Several chemical and physical attributes to minimize moisture ingress and manufacturing issues will be discussed. |
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| Abstract: |
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View Abstract
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| Times: |
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10/26/2010 -
Sessions are offered at 9 am Eastern Standard (NY)Time and 2 pm
Click Here to Register for Either Session
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| Title: |
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Collagen-glycosaminoglycan scaffolds: Lyophilization for wound care applications |
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| Presenter(s): |
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Dr. Brendan Harley, Dept. of Chemical and Biomolecular Engineering, University of Illinois at Urbana-Champaign |
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| Description: |
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Here we describe the fabrication, and characterization, and modeling of a series of non-mineralized and mineralized CG scaffolds. We then discuss their use in vivo to induce tissue regeneration following injury and in vitro as standardized 3D materials to study the influence of microstructural and mechanical features on cell behaviors such as motility and contraction |
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| Abstract: |
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View Abstract
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| Times: |
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11/17/2010 -
Sessions are offered at 9 am Eastern Standard (NY)Time and 2 pm
Click Here to Register for Either Session
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| Title: |
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Methods for Evaluating Lyophilized Product in a Laboratory Setting |
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| Presenter(s): |
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Wendy Sunderland, Lyophilization Technology |
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| Description: |
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Physical appearance of a lyophilized product can provide significant insight into the attributes of a product and relative effects of processing. Developing a detailed cake description during the development of a lyophilized product is important in order to discern subtle differences with regards to formulation variations, product designs, processing variables, and the impact of scale-up activities on product appearance. |
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| Abstract: |
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View Abstract
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| Times: |
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12/15/2010 -
Sessions are offered at 9 am Eastern Standard (NY)Time and 2 pm
Click Here to Register for Either Session
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