Blog & Resources Camargo Blog October 7th, 2015

The Winding Path to De-Risking Formulation Changes

Originally posted by AAPS Blog 10/7/15

If you are a researcher involved in drug development, you are familiar with the inevitability of change and the need to manage and understand it throughout the development process. No question, it is the status quo, and it must be planned for and managed. As researchers, we know where we want to go, but the path to the result is many times winding and forked. Which path we take will need to be justified and understood. Our overall goal is to be efficient and timely with our resources while expanding our understanding of the new drug product under development. Finally, we must be able to present a coherent data package to the review team at the Food and Drug Administration (FDA) such that they can readily access the information they need to determine the acceptability of the submission.

We start with the simplest and most appropriate dosage form for animal studies, then possibly the first in human clinical studies, the choice maybe an oral solution. Then we learn how to access the amorphic form of the API, which can be incorporated into a solid oral dosage form. Do we need to repeat all the animal studies that have already been finalized? Do any of the completed clinical studies need to be repeated? What information do we need to be able to connect the early understanding to the later development efforts and maintain a coherent development story? Can an in vitro method be used to show the similarities between the old formulation and the new formulation?

These are the types of topics that will be addressed by the three experts presenting at the Regulatory Sciences section open forum “De-risking” Formulation Changes during Early, Late Stage or Generic Development Using Science- and Risk-Based Approaches-Challenges, Opportunities and Regulatory Implications, on Wednesday, October 28 at the 2015 AAPS Annual Meeting and Exposition.

The program will begin with a review of the regulatory implications of de-risking formulation changes during development by Okponanabofa Eradiri, acting biopharmaceutics team leader at FDA. This will be followed by two industry experts describing some of the available tools for change management, biopharmaceutical approaches, predictive modeling approaches, and case studies, Joseph Kushner, senior principal scientist at Pfizer Inc., and David Good, senior research investigator at Bristol-Myers Squibb. Finally, the program will be wrapped up with Eradiri presenting opportunities and approaches to fill the existing gaps for management of change in the area of simple and complex dosage form development programs.

If you are looking for an exciting venue for vetting current practice and regulatory expectations with experts and peers in the pharmaceutical industry during the 2015 AAPS Annual Meeting in Orlando, sign up to attend this open forum!

By Lynn Gold, Ph.D.

Categories: 505(b)(2) Development

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