In this white paper, we detail IVRT methods pertaining to generic and innovator products and discuss their potential benefits in terms of quality, time, and cost. An associated case study illustrates key design and formulation considerations and ways to avoid common pitfalls.

In this white paper, we introduce the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, Sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs.

Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.