Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

We describe herein approaches and common pitfalls while submitting model based justifications as a response to the regulatory deficiencies during the generic drug development process. With some in-house case studies, we have attempted to provide a clear path for PBPK model based justifications for bio-waivers. With this review, the gap between theoretical knowledge and practical application of modelling and simulation tools for generic drug product development could be potentially reduced.Graphical abstract
Source: The AAPS Journal - Category: Drugs & Pharmacology Source Type: research