In Vitro Release Test and In Vitro-In Vivo Correlation of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on June 29, 2022 from 8:30 a.m. - 5:00 p.m.: In Vitro Release Test and In Vitro-In Vivo Correlation of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products.

Registration for this event is FREE. The webinar link will be accessible on the event page after registration. 

About the Event:

An in vitro release test (IVRT) can be an important tool to support a demonstration of bioequivalence and/or product quality for various generic drug products. In vitro-in vivo correlation (IVIVC) can allow a prediction of the in vivo performance of a drug based on the IVRT profiles, which can be used to support novel alternative in vitro-based bioequivalence approaches and/or post-approval changes to generic drugs.

The purpose of this workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking for IVRT and IVIVC studies to support the development and approval of complex generic ophthalmic, injectable, implantable, and inserted drug products. The workshop will provide an update on the progress of Generic Drug User Fee Amendments (GDUFA)-funded research activities, explore challenging issues that would benefit from a broader discussion, identify areas that need further research, and discuss opportunities for coordination and collaboration between FDA, generic drug industry, academic institutions, dissolution equipment manufacturers, contract research organizations, and consultants.

FDA and the Center for Research on Complex Generics (CRCG), 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.

Topics:

  • IVRT study design considerations for supporting bioequivalence and product quality, when applicable, for complex generic ophthalmic products, including emulsions, suspensions, ointments, and implants
  • IVRT study designs for supporting a demonstration of bioequivalence and as part of quality control for complex injectable generic products including suspensions, polymeric microspheres, in situ forming gels/implants, as well as implantable generic products including solid implants, intrauterine systems and intravaginal systems
  • Novel IVRT methods for supporting generic product development and/or bioequivalence demonstration
  • Theoretical principles and practical challenges of IVRT and IVIVC method development, validation, and transfer
  • Submission of IVRT information in Abbreviated New Drug Applications, including format of data/results, organization of information, and common deficiencies

Download speaker bios to learn more about the experts who will deliver presentations during the workshop.

Audience:

The generic drug industry, academic institutions, dissolution equipment manufacturers, contract research organizations, consultants, and others interested in the development of complex generic drug products.

Outline:

Session 1: Scientific and Regulatory Roles of In Vitro Release Test (IVRT) Studies
This session will share information on how IVRT studies have been used to support 1) generic product development, and 2) regulatory assessment of complex generic parenteral and ophthalmic products.

  • Presentations by experts from FDA, industry, and academia (2-3 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 2: IVRT Method Development and Validation
This session will discuss 1) scientific considerations and regulatory expectations for IVRT method development and validation, 2) common deficiencies observed during ANDA assessment; and 3) challenges faced with IVRT method development and validation during generic product development.

  • Presentations by experts from FDA and industry (3 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 3: In Vitro Vitro-In Vivo Correlation (IVIVC)for Complex Generic Parenteral and Ophthalmic Products
This session will describe the results of GDUFA science and research initiatives exploring IVIVC for complex generic parenteral and ophthalmic products.

  • Presentations by experts from FDA, industry, and academia (2-3 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 4: Novel IVRT Methods
This session will focus on novel IVRT methods that may be used to support product development and bioequivalence demonstrations for complex generic parenteral and ophthalmic products.

  • Presentations by experts from FDA, industry, and academia (2-3 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia 

For More Information:

If you have any questions about this workshop please contact complexgenerics@rx.umaryland.edu.