English to Russian Medical Medical: Pharmaceuticals

For investigational drug used in the ongoing clinical trials (Study 206 and Study 301), the capsule label claim was in units of potency per capsule.
Unit-based dosing ensured that changes in the specific activity of the enzyme did not affect the potency delivered to subjects in the trial.
Continued maturing of the ХХХХ Drug Substance manufacturing process has resulted in a ****reduction of variability in the potency**** of the ХХХХ Drug Substance enabling the manufacture of the ХХХХ Drug Product to move from unit-based dosing to mass-based dosing. Previously, the target potency was 3,750 u/capsule. In the move to mass-based dosing, the center point target of 3,750 u/capsule is unchanged. For investigational product used in the ongoing clinical trials (Study 206 and Study 301), the 3,750 u/capsule was filled with approximately 120 mg of oxalate decarboxylase enzyme.