Development of IVPT and IVRT Assays For The Evaluation of Topical Generic Products

Previously Aired on September 22nd, 2021

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Have you used or considered using in-vitro approaches to demonstrate generic product bioequivalence?

Yes, only for products where the product-specific guidance includes a recommendation for an in-vitro approachYes, irrespective of whether the product-specific guidance includes a recommendation for an in-vitro approachNo, I have not used/considered using in-vitro approach(es) to demonstrate bioequivalence * Required

Have you established or considered establishing IVRT and IVPT assays in-house?

Yes, I have established or considered establishing both, IVPT and IVRT assays in-houseYes, I have established/considered establishing IVPT onlyYes, I have established/considered establishing IVRT onlyNo, I have not established/considered establishing IVPT or IVRT assays in-house * Required

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Overview

This webinar will focus on the regulatory and scientific considerations (including test system- and product-related challenges) when optimizing and validating IVPT and IVRT assays to evaluate topical product performance.

In this webinar you’ll learn:

Current FDA Requirements for Development of IVPT and IVRT Assays to Demonstrate Product Bioequivalence
Study design considerations
Using IVPT and IVRT assays to guide formulation selection and development

Who should attend:

Pre-formulation/formulation scientists
Complex topical (e.g., ophthalmic, dermal) product developers
Topical product manufacturers
Regulatory scientists

Presenters

Aparna Ravikrishnan

(Presenter)
Senior Account Manager,
Absorption Systems, LLC
View Biography

Michael Auerbach

(Moderator) Editor-in-Chief
Pharmaceutical Outsourcing