BCS-based Biowaiver – Alternative to Human Bioequivalence Studies, Upcoming Webinar Hosted by Xtalks

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This webinar is directed towards understanding the BCS based in vitro Biowaiver studies from the regulatory perspective, which involve characterizing the comparative dissolution of Test and Innovator formulation, and solubility, gastrointestinal (GI) stability, and Caco-2 permeability of active pharmaceutical ingredient (API) for class I drugs. For class III drugs, emphasis is on the comparative dissolution profile between the Test and Innovator formulation, GI stability and excipient effects.

On a conservative basis, it is estimated to save ~ 120 – 140 million in dollars in clinical study costs per year through granting BCS based bio waivers for Class I and Class III drugs.

Biopharmaceutics classification system (BCS) based in vitro Biowaiver studies are employed to replace clinical BA-BE studies for new BCS class I generic drugs for approval without compromising the public health. Initially, these studies were applied for scale up and post approval changes (SUPAC) of generic product, and later extended to approval of orally administered BCS class I (high solubility and high permeability) and to class III (high solubility and low permeability) solid IR formulations. BCS based in vitro Biowaiver studies eliminates the unnecessary exposure of drugs to healthy volunteers with a significant economic relief to the pharmaceutical companies.

On a conservative basis, it is estimated to save ~ 120 – 140 million in dollars in clinical study costs per year through granting BCS based bio waivers for Class I and Class III drugs. This would certainly hasten up the approval times with rapid entry into the market, which further significantly reduce the cost of the generics.

Join Ansar Ali Khan, Ph.D., Associate Director, GLP - Test Facility Management, Aragen Life Sciences Private Limited (Formerly known as GVK Biosciences Private Limited) in a live webinar on Thursday, May 06, 2021 at 11am EDT (4pm BST/UK)

For more information, or to register for this free event, visit BCS-based Biowaiver for Generic, Branded BCS Class I and Class III Solid Dosage IR Formulations.

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Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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