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Integrated Product Assessment
A unique combination of Regulatory, Clinical, Pharmacometric and Systems Biology experience focused on improving drug development:
Clinical Benchmarking
Safety Assessment
Efficacy Assessment
Integrated Product Assessment
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
Estimation of clinical profile(s) of current Standard of Care
Quantitative assessment of efficacy and safety attributes
Defines performance hurdles agent(s) must meet or exceed to succeed
Also useful for preclinical-to-clinical scaling 2. Safety Assessment
Estimation of agent(s) tolerability profile 3. Efficacy Assessment
Estimation of agent(s) efficacy across range of potential indications 4. Integrated Product Assessment
Estimated clinical profile of therapeutic agent(s)
Utilizes all relevant data (public and private)
Focused on Target Product Profile 5. Modelling and Simulation of Pharmacodynamic and Pharmacokinetics
- Especifically, in the Clinical Benchmarking field, Anaxomics offers the following analysis:
A new therapeutic agent needs to perform at least as well as the current standard of care (SoC)
What performance benchmarks must the agent meet or exceed to be successful?
What are the current standards of care (SoC) within a particular indication?
Which endpoints were used for approval?
What were the range of observed effect sizes and variances for these endpoints across one or more SoC?
Known safety issues?
Other?
Public-domain data is extracted and analyzed
Also useful for estimating likely attributes of new therapeutic agent
Example: Range of Observed Outcomes for Treatment of Chronic Post-Herpetic Neuralgia Pain
Please, contact us here to request more information.


