QbD ANALYSIS

Elucidating Optimization Factors for Existing Formulations

QbD Analysis

Qrono can evaluate the quality performance of existing formulations, however they were designed.  With our QronoMetrics software, we can calculate how variations in material stocks and critical attributes impact formulation performance.

Using simulations that work backwards from therapeutic windows, we determine the potential for additional flexibility in formulation production:

  1. Input Therapeutic Specification
  2. Input API characteristics
  3. Input current material stocks
  4. Build model & run simulation
  5. Output Formulation Optimization Guidelines and Benefits

We also identify potential quality issues such as unacceptably high variance in pharmacokinetics and test solutions for these delivery challenges in silico.

Qrono’s QbD analysis service is the perfect choice for distinguishing between formulations with comparable in vitro or in vivo release profiles.  Qrono can compare each formulation’s susceptibility to quality errors arising from polymer chemistry, API purity and other variabilities.  Being able to easily select a well-designed formulation with reproducible performance upfront de-risks subsequent preclinical and clinical studies.

QbD Input Data

Review a sample inquiry questionnaire to understand the inputs we collect for QbD analysis.

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