Clinical Pharmacology is the study and use of drugs in humans. At Nuventra, we focus the action and uses of drugs related to human clinical studies supporting overall marketing applications to regulatory authorities. Typical clinical pharmacology studies supported by Nuventra look at drug-drug interactions, thorough QT (TQT) – cardiac repolarization, first time in human safety and PK, single and multiple dose effects, hepatic and renal impairment on drug action. All of these studies usually involve pharmacokinetics which Nuventra optimizes to produce robust results across any therapeutic area. Nuventra utilizes regulatory guidance documents, therapeutic area understanding, drug class characteristics, knowledge of current FDA requirements, past experience with similar development programs, and extensive knowledge of clinical pharmacology options to enable successful drug development programs.
Why put PK/PD first? Because Phase 1 studies are all about PK/PD and safety data. Phase 1 PK/PD data sets up your Phase 2 and 3 programs for success.
We are clinical pharmacology experts in PK/PD and are managing many ongoing Phase 1 trials.
Services from Nuventra that may be utilized in Phase 1 include:
- Full Service Clinical Conduct
- Study Protocol Development
- Pharmacokinetic Analyses and Reporting
- Clinical Study Report Authoring
- Clinical Pharmacology Plan
- Investigator Brochure Authoring and Update
- FDA Briefing Packet Preparation (e.g. for EOP1 meeting)
- Position or White papers (DDI waiver, pediatric strategy, etc.)
- Authoring Manuscripts for Peer-reviewed Journals
- Model Based Drug Development
- Clinical Operations Support/Project Management
Clinical pharmacology studies supported by Nuventra include:
- First-time-in-humans (FTIH) and Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Bioavailability (BA) & Bioequivalence (BE)
- Food Effect
- Drug-Drug Interaction (DDI)
- Thorough QT (TQT) Study – Cardiac Repolarization Study
- Hepatic Impaired
- Renal Impaired
- Site of Absorption
- PK sub-study in Phase 2-3
- Phase 2 & 3 Population PK
- Model Based Drug Development and Simulation
Phase 1 Model-Based Drug Development (MBDD)
The overall goal of model based drug development is to illuminate drug development strategies and improve decision-making within clinical development programs. Learn more.
Using mathematical and statistical methods, we build models of drug concentration (pharmacokinetic) and/or drug response (pharmacodynamic) over a time course (PK/PD), which can play a critical role throughout the drug development process.
- Early Phase Clinical Development (Phase 1): Early human pharmacokinetic or pharmacodynamic data can be used to develop the next stage of models of human exposure and/or pharmacodynamic response. A real-time model-based approach may be particularly useful to guide dose escalation during the conduct of ascending-dose studies. Upon completion of these studies, simulations based on the final model(s) can be a valuable resource when designing and optimizing longer-term studies. Learn more.