Featured Webcasts:
OnDemand Webcast
Protect IP and Reduce the "Sign and Witness" Burden in Lab Informatics Systems
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.
OnDemand Webcast
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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