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Featured Whitepaper
Challenging the drug development blueprint: A formulator’s perspective
Author: John G. Augustine, Ph.D.
Sponsored By: SP Formulations
Dr. John Augustine, Formulations Manager, offers practical advice that can help to increase the likelihood of successful drug development. Innovatively applying concepts and tools from formulation development earlier can add formulation criteria to the selection process and help inform the selection of an API for continued development.
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Topical Dermatological Formulation Development – “Things You Should Know”
Author: Vanlee Waters M.B.A., Marketing Manager, Dow Pharmaceutical Sciences, inc.
Sponsored By: Dow Pharmaceutical Sciences, Inc.
“Things You Should Know” will answer many of your questions and will provide insight into issues you may not have considered -- but should be aware when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed.
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Custom Manufacturing Driven By Core Competencies
Authors: Torsten Woehr, Ph.D. and Mark New, Ph.D., Genzyme Pharmaceuticals
Sponsored By: Genzyme
With global competition in custom manufacturing dramatically shifting, companies are changing business strategies to extend geographic presence, create low-cost production capacities, develop investment-intensive chemistry capabilities, or further leverage existing economies-of-scale. Genzyme Pharmaceuticals' custom manufacturing business is based on long-standing competencies and technologies. By striving for leadership in niche technologies, Genzyme Pharmaceuticals has the strategic vision to strengthen its business and develop new market opportunities. |
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Protect Your Scientific Intellectual Property: Proof of Lab Informatics Data Authenticity is Your Best Legal Defense
Sponsored By: Surety, LLC
As a pharmaceutical or biotechnology organization, your formulas, treatments and clinical findings are the "lifeblood" of your business. But if you aren't protecting the integrity of your scientific data in your lab informatics systems, you risk losing ownership, revenue and consequently your business if you can't prove time-of-creation and authenticity. Learn how you can implement simple, cost-effective, and transparent controls to protect your scientific intellectual property.
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Technology Approaches to Quality Management
Author: Mike Jovanis
Sponsored By: Sparta Systems Europe, Ltd.
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com. |
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Protecting Sensitive Information in Life Sciences Organizations:
Top Three Misconceptions that Put Companies at Risk
Sponsored By: Brainloop
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TECHNICAL TRANSFER DOCUMENTATION IS KEY FOR SUCCESS
Author: Tom Hughes
Sponsored By: Carton Service-Packaging Insights
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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