Confidence Beyond Compliance

PharmaLex has significant expertise in supporting discovery laboratories in pharmaceutical sciences with great emphasis on in-vitro and in-vivo animal models to ensure the studies are adequately reproducible and predictive to support decision making. PharmaLex applies a LifeCycle vision and Quality by Design (QbD) approach for in-vitro and in-vivo assays that starts by the definition of the objectives and aims and ends with a control strategy. In between, best practice of Design of experiments (DoE), advanced modeling and Bayesian statistics are applied to ensure reproducibility and predictability of results.

Our services include:

Statistics for the development and qualification of bioassays

  • HTS, LTS
  • Design of experiments
  • Advanced signal processing
  • Optimization and qualification
  • Parallelism assessment and determination
  • Multicriteria decision making and ranking of compounds
  • Z score, Uncertainty
  • Reproducibility evaluation
  • Transfer and comparisons
  • Control strategies

Statistics for the development of in-vivo pharmacology models

  • Design and optimization
  • Powering for reproducibility, Z score
  • Development of accurate end-points
  • Modeling to support translation to human
  • PK/PD, non-linear and Bayesian models
  • 3R methodologies and comparison
  • Historical control groups
  • Control strategies

Development of biomarkers

  • Identification of biomarkers
  • Control of FDR (False Discovery rates)
  • Evaluation of performances (Sensitivity, Specificity, ROC, NPV, PPV)
  • Development and validation of kits
  • Optimization and design of clinical trial to qualify biomarkers
  • Multiplex

Therapeutic areas

  • Immunology
  • Oncology (Xenograft models, …)
  • Metabolic disorders
  • CNS
  • Cardiology
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