According to a recent survey, 86% of companies have seen pre-clinical PK/PD analysis impact drug development.
Benefits to gain from successful implementation of simulation strategies can be enormous. Trial simulation strategies have been successfully employed to:
- Help determine the impact of formulation changes on clinical response and assist in optimal formulation selection based on both pharmacokinetic and pharmacodynamic considerations
- Help determine the most robust clinical trial design with respect to study design, patient numbers and number of dose groups, thereby minimizing time and cost
- Gain early insight on future dosing regimens, thereby expediting protocol development and compressing development timelines
- Risk mitigation potential offered in late stage clinical development where the use of modeling and simulation can substantially improve the quality of critical go/no go drug development decisions and help identify the optimal dose and dosing regimen to take forward into costly registration trials
Our quantitative modeling and simulation technology can be leveraged to help you efficiently achieve the following developmental goals:
- Correct selection of the drug dose and schedule
- Designing fewer, smaller, more efficient clinical trials
- Improving interactions with regulatory authorities
- Developing therapeutics with better benefit/risk profiles
- Attracting investor funding or securing a development partner
By choosing a team that specializes in clinical trial simulation and modeling, pharmaceutical companies can expect a higher return on investment, and are able to avoid hazards in their drug development program, including unnecessary cost of development, increased time to approval, or in some cases both.
With Synteract’s recent acquisition of KinderPharm with its extended team of PKPD scientists, we can bring advanced pharmacometric modeling and clinical trial simulation technologies to both adult and pediatric drug development across the spectrum of therapeutic areas.
At Synteract we can help support drug development decisions and new drug approvals using our advanced pharmacometric modeling and clinical trial simulation technologies. Contact us if you need help with implementing appropriate PK/PD models or other aspects of modeling and simulation for your clinical trial.
