Pharmaron eBook cover promoting the "BCS-Based Biowaivers Reference Guide (2nd Edition)" with a download button, emphasizing laboratory services, clinical development, and biologics.

Streamlining Drug Development with BCS Classification and BCS-Based Biowaivers

The Biopharmaceutics Classification System (BCS) is a globally recognized scientific framework that categorizes drug substances based on their aqueous solubility and intestinal permeability. This system underpins BCS-based biowaivers, allowing pharmaceutical developers to forgo costly and time-consuming in vivo bioequivalence (BE) studies in favor of validated in vitro tests for immediate-release oral solid dosage forms.

Pharmaron’s BCS-Based Biowaivers Reference Guide (2nd Edition) offers a comprehensive look at the evolving regulatory landscape, providing clarity on when and how a biowaiver may be applicable. This document serves as a valuable resource for professionals developing new chemical entities (NCEs) or generic formulations, and outlines Pharmaron’s methodologies and proven success in achieving regulatory approvals.

What is BCS Classification?

The BCS categorizes drugs into four classes:

Class I: High solubility, high permeability
Class II: Low solubility, high permeability
Class III: High solubility, low permeability
Class IV: Low solubility, low permeability

Capabilities

Knowledge Center

DMPK Services

Regulatory in vitro ADMET Studies

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Classes I and III are eligible for biowaivers under current FDA and ICH M9 guidelines if they meet specific in vitro dissolution and permeability criteria.

Regulatory Alignment and Methodology

The FDA, EMA, and ICH have harmonized biowaiver criteria under the M9 BCS-Based Biowaiver Guideline (2021), which allows broader application, including Class III drugs under stringent excipient control. Pharmaron’s validated Caco-2 permeability assays and proprietary IDAS system (In Vitro Dissolution Absorption System) ensure high-quality data aligned with global regulatory expectations.

Why Choose Pharmaron?

With over 600 successful BCS studies conducted, Pharmaron is a leader in biowaiver applications, serving eight of the world’s ten largest generic pharmaceutical companies. Their comprehensive service suite includes:

Preliminary permeability screening
Solubility profiling across pH ranges
Expert regulatory support
Full GLP-compliant in vitro studies

Scientist using a dissolution system to evaluate drug release, supporting BCS classification and potential biowaivers for oral formulations.