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Have You Seen FDA's article on Deficiencies in New Drug Applications on PharmTech.com?
Interested in Learning About Other Topics?
Give us your ideas for a Future Webcast or Podcast
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Featured Webcasts:
Tuesday, September 14, 2010
11:00 AM EDT
Pharmaceutical Melt Extrusion: A Strategy for Poorly Soluble Drugs
Finding ways to improve the solubility and bioavailability of poorly soluble drugs is of crucial importance to pharmaceutical companies. Industry estimates indicate that approximately 40% of commercial drugs and 60% of drugs under development may be considered poorly soluble. Pharmaceutical development scientists face the challenge of developing formulations and processes for poorly soluble drugs with minimal time for experimental work and limited supply of expensive new chemical entities (NCEs). This 60-min Webcast will offer insight from leading industry experts on solid-dispersion technologies used to enhance solubility when formulating poorly soluble drugs. Gain insight into how melt extrusion is used in the pharmaceutical industry and of a systematic approach for initial feasibility development of formulation and processes involving pharmaceutical melt extrusion. This approach, Melt Extrusion Modeling & Formulation Information System (MEMFIS), helps in selecting lead formulations with no API consumption, using mathematical models and algorithms based on solubility parameter theories (i.e. hydrogen bonding, polar and dispersive forces), which ensure the stabilization of the system through hydrogen bonding.
Wednesday, September 15, 2010
1:00 PM EDT
Topical Drug Product Development: Overcoming CMC Issues and Pitfalls - Analytical & Regulatory
Learn from one of the most experienced and successful topical product development service providers in the world, Dow Pharmaceutical Sciences, during this webcast entitled, "Topical Drug Product Development: Overcoming CMC Issues and Pitfalls - Analytical & Regulatory." If you are considering topical dermatological product development, it is important that you understand the unique CMC (chemistry, manufacturing, and controls) issues involved with topicals and how they might affect your IND or NDA submission. This webcast addresses a multitude of “real world” challenges analytical teams face during stability assessment of semi-solid formulations. Most importantly, learn from multiple case studies of issues during clinical stability programs and regulatory submissions including development of specifications, impurities, degradation products, analytical method development, photosafety and packaging components.
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OnDemand Webcast
Building Quality into the Selection and Sourcing of Pharma Ingredients Strategies - from research through commercial manufacture
Ensuring the quality and the reliability of supply of raw materials, pharmaceutical intermediates, excipients, and active pharmaceutical ingredients (API) throughout drug development to commercial manufacture is of critical importance. Successfully developing and executing a cost-efficient and effective manufacturing process require all functional areas - medicinal chemistry, process R&D, quality assurance/quality control, sourcing/procurement, and manufacturing - to have a common understanding of the pitfalls to avoid and the best practices to follow in selecting, sourcing, and procuring the chemicals used in API and finished-drug product manufacturing. This 60-min Webcast will offer insight from leading industry experts on how to build quality and mitigate risk in a pharmaceutical manufacturing process from R&D, to clinical-trial materials supply, to commercial manufacture by providing practical solutions on ingredient selection, sourcing strategies, supplier audits, and supply-chain management.
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Featured Whitepapers:
Clean-In-Place Automation - Glatt Coating Pan
This case study covers the implementation of an automated Clean-In-Place system into a Solid Dosage application of a Glatt Coating Pan. This application resulted in the automation of a manual cleaning process while shortening time to clean and improving the quality and consistency of clean.
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Moisture Activated Dry Granulation Using Starch
Using pregelatinized starch as the absorbent diluent in the Moisture Activated Dry Granulation (MADG) process, combinations of maltodextrin and povidone were tested to determine optimum binder level.
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Controlling Airflow in Class II Biosafety Cabinets
The process of “teaching” the ECM to deliver constant airflow volume in a Class II biosafety cabinet is a patent-pending process developed by Labconco, called the Constant Airflow Profile (CAP).
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The New Approach to Track and Trace
As pharmaceutical manufacturers confront increased margin pressure, they will look for new ways to lower costs of installing and maintaining production lines. Choosing smart camera vision systems over PC-based vision systems can be an advantage that often results in a solution that’s less expensive to install and maintain.
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| Featured Content:
Statistical Considerations in Design Space Development
The US Food and Drug Administration’s quality initiative for the 21st century seeks a new paradigm for pharmaceutical assessment. Design space and the statistics used in its development play an important role. The first in a three-part series, this article provides concise answers to frequently asked questions related to the statistical aspects of determining a design space as part of current quality-by-design initiatives. In parts II and III, the authors offer statistical tools used in experimental planning and strategy, as well as methods for evaluating the resulting design space and representing it graphically.
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