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  4. FDA and ASCPT Co-Sponsored ASCPT 2019 Pre-conference: PBPK Modeling for the Development and Approval of Locally Acting Drug Products - 03/13/2019 - 03/13/2019
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Conference | In Person

Event Title
FDA and ASCPT Co-Sponsored ASCPT 2019 Pre-conference: PBPK Modeling for the Development and Approval of Locally Acting Drug Products
March 13, 2019

Scheduled
Date:
March 13, 2019
Organized By:
Organizer

Date: March 13, 2019

Location:

Marriott Wardman Park Hotel
2660 Woodley Road,
NW Washington, DC 20008

Background:

Recent advancement of physiologically-based PK (PBPK) models for drugs delivered directly to sites of action in the skin, lung, eyes, nose, or gastrointestinal tract, can aid in product development and identifying the most efficient bioequivalence (BE) studies. Demonstrating BE for generic locally-acting drug products is challenging because local drug concentrations at the site of action may not be measured directly and systemic drug exposure may not be reflective of local drug delivery at the site of action. PBPK models that integrate information about both the physiological systems and the drug product to make predictions about biodistribution of locally acting drug products have the potential to be an integral part of the development and approval of generic locally acting products.

Goals and Objectives:

  • To provide a forum for open discussion on the challenges and critical role of PBPK for locally acting drug products in regulatory decisions
  • To recognize challenges and opportunities for PBPK with inhalation drug products, dermal drug delivery and ophthalmic drug products 
  • To discuss challenges and opportunities for the science community in enhancing PBPK models

Who should attend?

This ASCPT 2019 Pre-conference on PBPK Modeling for the Development and Approval of Locally Acting Drug Products is intended for scientists from academia, industry, and regulatory agencies committed to improving drug discovery, development, and review. This workshop will be especially valuable to industry developing products that need to demonstrate bioequivalence to a locally acting drug product.

Registration:

ASCPT 2019 Pre-conference Registration

Contacts:

Kris Andre: kris.andre@fda.hhs.gov

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Contact

Event Contact
Office of Generic Drugs
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