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  4. FDA/CRCG Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products - 04/20/2023
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Public | Virtual

Event Title
FDA/CRCG Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products
April 20 - 21, 2023


Date:
April 20 - 21, 2023
Day1:
- ET
Day2:
- ET

Register here.

About the Event:

FDA recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs) often involve study designs for conducting comparative clinical endpoint (CCEP) and pharmacodynamic (PD) BE studies. Considering the difficulties that these studies can present for generic drug developers, FDA product-specific guidance (PSG) recommendations for some OIDPs have included alternative BE approaches that do not involve CCEP BE studies. However, understanding what studies may be suitable as part of an alternative BE approach can be difficult when developing generics for certain inhalation products with complex formulations, such as suspension-based metered dose inhalers (MDIs) and dry powder inhalers (DPIs).

The purpose of this two-day OIDP workshop is to discuss the current scientific and regulatory perspectives for using in vitro, in vivo, and in silico studies as alternatives to CCEP and PD BE studies, and to explore potential designs for alternative BE approaches that can address the particular challenges associated with establishing local drug delivery equivalence for suspension-based MDIs and DPIs. The workshop will begin with a reflection on the successes, limitations, and challenges with BE approaches that include CCEP and PD BE studies. Next, two parallel sessions will provide focused discussion on the in vitro, in vivo, and in silico studies that may serve as alternatives to CCEP and PD BE studies, where these interactive sessions will allow for small group discussions centered on the technical and practical aspects of these studies when used across OIDPs. The workshop will conclude with panel discussions for MDIs and DPIs that will provide participants the opportunity to discuss their study designs and issues with applying alternative BE approaches in lieu of CCEP and PD BE studies, with the goal of identifying where consensus can be achieved between collaborators from government, industry, and academia on what may constitute adequate alternative BE approaches for complex OIDPs.

Hybrid Experience:

The workshop will offer both in-person and remote attendance options. The event will be held at the Universities at Shady Grove in Rockville, Maryland.

Workshop Topics:

  • Reviewing successes with the use of CCEP and PD BE studies to establish BE for locally acting OIDPs, and discussing relevant challenges
  • Evaluating alternative BE approaches that utilize in vitro, in vivo, and in silico studies, instead of CCEP and PD BE studies, and discussing relevant technical and practical issues when used with different OIDPs
  • Discussing the integration of multiple alternative in vitro, in vivo, and in silico studies to form cohesive alternative BE approaches in lieu of CCEP or PD BE studies for MDIs and DPIs

FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.

Audience:

This workshop is primarily suggested for the generic drug industry and other involved collaborators, including consultants and contract research organizations that support generic drug applications.

Registration Fees:

This workshop is FREE for virtual attendees. The cost for in-person attendance is $425 and will cover event related expenses.

For more information, visit the Center for Research on Complex Generics (CRCG) website.

 
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