Ashland Pharmaceuticals klucel™ xtend hpc klucel fusion™ hpc

Ashland webinar:
regulatory guidance for using the US Food & Drug Association Inactive Ingredient Database (IID)


NA/LATAM: Tuesday, 10:00 a.m. EDT – 23 July 2024
EMEA/APAC: Wednesday, 1:00 p.m. CET – 24 July 2024

The US Food & Drug Association (FDA) Inactive Ingredient Database (IID) provides information about inactive ingredients present in FDA-approved drug products. The industry can use this information as an aid when developing drug products. For this purpose, when an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered ‘new’ and may require a less extensive review the next time it is included in a new drug product.

This webinar will provide an overview of the IID along with guidance on its use. We will use klucel™ hydroxypropylcellulose as a typical pharmaceutical excipient. We will demonstrate how Ashland has used the IID to decide the maximum daily exposure (MDE) of klucel™ hydroxypropylcellulose in an approved pharmaceutical drug product.

key learning objectives:

  • understanding of the information contained in IID and how to use it
  • an overview using available tools to evaluate the maximum daily exposure (MDE) of an excipient
  • use of IID when evaluating klucel™ hydroxypropylcellulose


presenter information:

 

 

Fernando Mucelin
Sr. Manager Life Sciences Regulatory Affairs – Americas, Ashland

Fernando Mucelin is an accomplished regulatory and quality professional with more than 20 years of experience at Ashland, having expertise in pharmaceutical excipients and chemicals. Fernando is the chair of IPEC - Americas Latin America Working Group with a mission to educate, innovate, and develop best practices for pharmaceutical excipients in the region while prioritizing patients’ safety and drug product efficacy. He holds a degree in environmental engineering from Pontifical Catholic University of Campinas, Brazil. Prior to joining Ashland, Fernando was a lab analyst with Nutron.


 

 

 

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