To improve efficiency, reduce costs, and bring high-quality therapies to patients faster, Vilintra is implementing the ICH M13 Guidelines. Our clinical trial management solutions are aligning with the latest global standards for bioequivalence (BE) studies.

What are the ICH M13 Guidelines?

The ICH M13 Guidelines were developed by the International Council for Harmonisation (ICH) for bioequivalence study designs and regulatory standards for immediate-release (IR) solid oral dosage forms. These guidelines aim to reduce the need for duplicative studies across jurisdictions, streamline drug development processes, and promote consistent BE standards worldwide.

By addressing critical areas such as study design, data analysis, biowaivers and advanced considerations for highly variable drugs, the M13 guidelines improve bioequivalence assessments.

Why does ICH M13 matter?

Global Harmonization Benefits

The adoption of ICH M13 enables Vilintra to provide solutions that meet the harmonized standards for bioequivalence studies across multiple regions. This reduces the need for clients to duplicate BE studies for different regulatory submissions, saving time, resources, and costs while improving global drug accessibility.

Streamlined Compliance

ICH M13's structured framework integrates into Vilintra’s Pharmaceutical Trial Management Solution (PTMS). M13's risk-based principles enable trial designs, data integrity, and reporting processes to comply with global requirements, minimizing regulatory hurdles.

Patient-Centric Approach

Harmonizing BE guidelines reduces unnecessary duplication of studies, meaning fewer human subjects are needed for trials. This patient-first focus aligns with Vilintra’s core mission to promote ethical and efficient clinical research.

Vilintra’s Implementation of ICH M13 Principles

1. Risk-Based Study Design

Vilintra’s PTMS incorporates ICH M13’s emphasis on a risk-based approach to the BE study design. Whether conducting single-dose, crossover, or parallel trials, our platform optimizes study parameters such as:

• Sampling schedules.
• Handling of outliers.
• Analysis of drugs with narrow therapeutic indices.

Accurate, reliable, and regulatory-compliant outcomes for immediate-release formulations.

2. Continuous Updates

Vilintra is committed to adapting our systems to incorporate future annexes on advanced topics like:

• Highly variable drugs.
• Truncated AUC analysis.
• Drugs with a narrow therapeutic index.

Our clients stay ahead of regulatory changes and maintain compliance with the latest standards.

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