RESEARCH & DEVELOPMENT

Supporting clinical pharmacology throughout its life‑cycle

With pharmacokinetic/pharmacodynamic modeling. Our Clinical Pharmacology team can work with you through the entire life cycle of development, from pre-IND through to regulatory submission.

Support for all Phases

IQVIA Pharmacology can support you in crafting the Model-Informed Drug Development Plan (MIDD) and help with dosing strategy and execution. If you have concerns about the FDA’s Project Optimus, we are here to help.

See how we can help support you through your pharmacology lifecycle click the icons for more info.

Early Development

When it comes to early phase development our pharmacology team have a host of service and solutions to help you through this embryonic phase from:

  • SAD/MAD studies, special populations, and proof of concept studies.
  • Designing dose-finding algorithm,
  • Precision dosing expertise
  • Providing Phase 1 pharmacology support
  • Dose/toxicity modeling

Late Phase

Gain support in your label claims and special populations studies with our expert PK modeling. We have submitted modeling for more than 100 molecules and engage in industry standard processes that are accepted by the regulators. We also provide:

  • Exposure-response modelling
  • Dose regime determination.
  • Population PK Modeling

Dose Finding

When you need additional support in defining the optimal dose for latter phase trials, we can help through greatly improving the probability of success. Our Pharmacokinetic modeling solutions provides better accuracy at estimating the dose and build precision dosing algorithms to further enhance study development and aid in optimizing the sample size significantly by reducing the PK variability so that only the PD variability is exhibited in the endpoints.

Regulatory Modeling

Our team provide responses to regulatory questions with modeling and engage with you in supporting regulatory claims through modeling and Pediatric extensions

Technology Solutions

We work with you in the development of dosing applications to support product sales and aid in precision dosing using our dedicated applications for customer support

Related Solutions

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