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Featured Whitepaper
Developing and Validating Dissolution Procedures for Improved Product Quality
Authors: Michael Swartz, Ph. D., Director of Research and Development and
Mark Emanuele, Chemist; Sponsored By: Synomics Pharmaceutical Services
Drug manufacturers use in vitro dissolution performance tests for solid oral dosage forms, such as tablets and capsules, to assess the lot-to-lot quality of a drug product, guide development of new formulations, and ensure product quality and performance after changes in the manufacturing process. Like any performance test conducted in a regulated environment, the dissolution procedure must be properly developed and validated to achieve the best results. A white paper from Synomics Pharma, titled "Developing and Validating Dissolution Procedures for Improved Product Quality", discusses the general concepts and highlights some specific method validation guidelines used in developing and validating dissolution test procedures.
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Technology Approaches to Quality Management
Author: Mike Jovanis;
Sponsored By: Sparta Systems Europe, Ltd.
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations. These pressures stem from a number of different areas including a wide range of international regulatory authorities, global customers and other key stakeholders. |
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The U.S. FDA orphan Drug Product Program
Sponsored By: Beckloff
The Orphan Drug White Paper provides a description of the history and content of the Orphan Drug Act including various statistics through 2005. The paper also describes the orphan drug designation and orphan drug grant processes in sufficient detail for applicants to be able to file an orphan drug designation or grant request. |
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Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging
Sponsored By: Symetix
Achieve new levels of product quality and inspection efficiency in the manufacturing and packaging of tablets. Learn the pros and cons of manual inspection, mechanical sorting, blistering, single-file optical systems and a new class of automated, bulk vision inspection systems. The latest technology is keeping pace with the increasing demand for top-quality products. Learn how it helps minimize risk, increase throughput and contain costs. |
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Topical Dermatological Formulation Development - "Things You Should Know"
Author: Vanlee Waters M.B.A., Marketing Manager; 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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The Three Most Common Defects
Author: Michael Tousey; Sponsored By: Techceuticals
Defects cost companies thousands of dollars in lost product, lost time, decreased productivity, increased downtime, increased machine cleaning, repair costs, and more. The average company has about $250,000 lost to defects each and every year. Techceuticals shows you how to eliminate this! |
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Protect Your Intellectual Property: Proof of Authenticity is Your Best Defense
Author: Tom Klaff, CEO; Sponsored By: Surety, LLC
In today's digital world, altering an electronic document or record containing critical formulas or data takes nothing more than motive and a keystroke - forcing R&D organizations to rely on the trustworthiness of their people, processes and technology to vouch for the authenticity of their records. You insure your employees, your buildings, your products and your systems against unforeseen trouble.why wouldn't you protect the integrity of your organization's critical electronic content the same way? |
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Preparing for Mandatory Electronic Submission
Sponsored By: Beckloff
New requirements for electronic drug establishment registration and drug listing submissions to FDA take effect June 1, 2009. It is time to understand the requirements, and to make sure you have a solution in place to keep your establishment registrations and drug listings current. |
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A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions
Sponsored By: Beckloff
Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic (eCTD) format for their marketing applications to FDA. Given the current difficult economic environment, sponsors, especially those with modest submission volumes, should consider outsourcing as a great option to enable the strategic benefits of eCTD while significantly reducing the barriers.
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Risk Evaluation and Mitigation Strategies (REMS) Under FDAAA
Sponsored By: Beckloff
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA’s ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. 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. |
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