Clinical Dose Converter

A critical tool for formulators to translate clinical trial dosages—often expressed in mass (mg) or historical CFU counts—into actionable formulation targets.

The Problem of Equivalence

A specific question answered: How do I formulate a product when the clinical trial used a lyophilized powder mass instead of a CFU count? You must obtain the specific potency of the raw material (CFU/g) at the time of manufacture. This tool provides standardized conversions based on typical high-potency raw materials.

Worked Example

A clinical trial establishes efficacy at 10 × 10⁹ CFU. If using a raw material supplied at 100 × 10⁹ CFU/g, and requiring a 20% overage for shelf-life stability, the calculation is:

• Base mass: (10 / 100) * 1000 = 100mg
• Overage: 100mg * 1.20 = 120mg required per capsule.

Common Mistakes in Formulation

1. Forgetting Overage: Clinical trials often report the administered dose at time of consumption. Formulators must add significant overage (often 20-50%) to ensure that end-of-shelf-life counts meet the clinical target.
2. Assuming Consistent Potency: Raw material potency varies by batch. Always formulate based on the specific Certificate of Analysis (CoA) for the lot.

Frequently Asked Questions

Next Steps

Once you have calculated your required dosage mass, verify the viability loss over time using our CFU Degradation Modeler. If you need assistance translating older clinical data, consider our Advisory Services.