E-BOOK: BCS-Based Biowaivers

For over 20 years, the USFDA has advocated the Biopharmaceutics Classification System (BCS) as a regulatory mechanism for drug developers and generic companies to obtain waivers of clinical bioequivalence studies, also known as biowaivers.

This booklet was written by a team of experts at Pharmaron. It is our hope that you will benefit from the information, guidance, and considerations it contains to progress your small molecule testing program, including considerations from the recently published M-9 Guidance.

Included in the guide:

  • What is BCS?
  • What is a biowaiver?
  • What are the benefits of a BCS biowaiver?
  • When can you apply for a biowaiver?
  • When are BCS biowaivers not applicable?
  • International regulatory framework
  • How Pharmaron supports BCS Biowaiver applications
  • Common pitfalls in BCS experiments
  • Frequently asked questions
  • And much more

Request your copy today!

Knowing the BCS class of your compound can help:

  • Predict in vivo absorption
  • Predict disposition
  • Potential for food effects
  • Guide your formulation strategy
  • Potentially waive clinical studies