How does dose formulation work?

KCAS Bio provides comprehensive dose formulation services to support drug development from discovery through clinical trials. Our approach ensures your compound is delivered safely, accurately, and consistently.

Dose Formulation Process Overview

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Step 1: Project Planning and Study Requirements
We start by reviewing your study protocol, compound characteristics, and target doses. This step ensures the formulation plan aligns with your preclinical or clinical objectives.
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Step 2: Compound Assessment
Our scientists evaluate the physicochemical properties of your compound, including solubility, stability, and compatibility with the intended vehicle.
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Step 3: Formulation Preparation
The compound is accurately weighed and combined with the chosen vehicle using precise mixing techniques to achieve the desired concentration and homogeneity.
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Step 4: Method Development & Validation
Analytical methods are developed to quantify the compound and ensure formulation accuracy. Method validation confirms the method is robust and reliable.
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Step 5: Quality Control & Testing
Each batch undergoes rigorous testing, including concentration verification, homogeneity checks, and stability assessments. Certificates of Analysis (CoA) or Certificates of Testing (CoT) are available.
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Step 6: Stability and Storage
Formulations are monitored under defined storage conditions to confirm stability over the study duration.
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Step 7: Dosing & Documentation
Prepared formulations are delivered for study use, accompanied by detailed documentation for regulatory compliance.

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