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Study Design and Data Analysis

We design efficient and informative studies and analyze them using statistical and pharmacometric approaches that enable us to extract a deeper understanding of and value from study data. The studies are designed to enable the ease of dose selection and dosage optimization. We develop models which can provide a clear understanding of drug action, efficacy, and safety, potentially reducing the risk and duration of the development process, and therefore delivering more value for each drug development dollar spent.

We Apply our design and analysis methods to:


Clinical Pharmacology Studies

  • First-Time-in-Human, including
    Animal-to-Man Interspecies Scaling
  • Mass Balance
  • Healthy Subject and Patient PK/PD
  • Thorough QT/QTc
  • Drug-Drug Interaction
  • Special Population
  • Bridging Studies
  • Proof-of-Concept.

Biopharmaceutic Studies

  • Bioavailability
  • Bioequivalence
  • Food Effect
  • Model-based methods for formulation development

Intermediate and Late Phase Clinical Studies

  • Dose Finding
  • Dose Response
  • Pivotal Safety and Efficacy
  • Combination Therapy
  • Pediatric Bridging

Other Analysis Services


Interim Analysis

We can provide Sponsors with external unblinded analysis of interim efficacy, safety, or PK/PD data. Such analyses can be used to support the activities of a Data Monitoring Board or internal decision making while minimizing risk to the integrity of the study blind.


Real-Time Data Analysis

Anoixis Corporation can support Sponsor needs for real-time or near-real time analysis of PK or PK/PD data to aid in the adaptation of a clinical study or inform decision-making.


Analysis of Uncompleted Studies

Using pharmacometric knowledge discovery and creation methods we are able to extract hidden knowledge from clinical study data obtained from a study that was stopped abruptly, either for preclinical toxicological finding or other reasons. Such knowledge provides our partners with insight into what would have been the outcome of such a trial. The data set used for these types of analyses must satisfy certain conditions.

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