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Integrated Product Assessment

A unique combination of Regulatory, Clinical, Pharmacometric and Systems Biology experience focused on improving drug development:
  • puntoClinical Benchmarking
  • punto Safety Assessment
  • punto Efficacy Assessment
  • punto Integrated Product Assessment
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Anaxomics provides not only the mechanistic and predictive analysis of your products therapeutic performance, but we offer a full range of strategic knowledge to help you add value and differentiate your new developments. Our projects are comprehensive and include much more than Systems Biology.

  • 1. Clinical Benchmarking

  • punto Estimation of clinical profile(s) of current Standard of Care
      punto Quantitative assessment of efficacy and safety attributes
  • punto Defines performance hurdles agent(s) must meet or exceed to succeed
  • punto Also useful for preclinical-to-clinical scaling

  • 2. Safety Assessment

  • punto Estimation of agent(s) tolerability profile

  • 3. Efficacy Assessment

  • punto Estimation of agent(s) efficacy across range of potential indications

  • 4. Integrated Product Assessment

  • punto Estimated clinical profile of therapeutic agent(s)
      punto Utilizes all relevant data (public and private)
  • punto Focused on Target Product Profile

  • 5. Modelling and Simulation of Pharmacodynamic and Pharmacokinetics



  • Especifically, in the Clinical Benchmarking field, Anaxomics offers the following analysis:
  • punto A new therapeutic agent needs to perform at least as well as the current standard of care (SoC)
  • punto What performance benchmarks must the agent meet or exceed to be successful?
  • punto What are the current standards of care (SoC) within a particular indication?
  • punto Which endpoints were used for approval?
      punto What were the range of observed effect sizes and variances for these endpoints across one or more SoC?
      punto Known safety issues?
      punto Other?
  • punto Public-domain data is extracted and analyzed
  • punto Also useful for estimating likely attributes of new therapeutic agent


Example: Range of Observed Outcomes for Treatment of Chronic Post-Herpetic Neuralgia Pain

Range of Observed Outcomes for Treatment of Chronic Post-Herpetic Neuralgia Pain
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punto cuadradoPlease, contact us here to request more information.
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