Many late phase studies involve the measurement of drug concentration (pharmacokinetics) and seek to correlate the action of drug (pharmacodynamics) to drug concentrations (PK/PD).
Nuventra services that may be utilized in Phase 2 and 3 include:
- Study Protocol development
- Traditional Pharmacokinetic analyses and reporting
- Population Pharmacokinetic analysis and modeling
- Clinical Study Report authoring
- Investigator Brochure update
- FDA Briefing Packet preparation (e.g. for EOP2 or Pre-NDA meeting)
- Preparation of NDA/BLA sections
- Authoring manuscripts for peer-reviewed journals
- Clinical Pharmacology studies needed for NDA that have not been completed prior to Phase 3
- Clinical Pharmacology studies needed to de-risk drug development programs and plan for Phase 3 pivotal studies (e.g., drug-drug interactions studies [DDI], hepatic and renal impaired studies, cardiac conduction [thorough QT or TQT] study, bioequivalence study of a new formulation, if not conducted prior to Phase 2).
Phase 2 & 3 Model-Based Drug Development (MBDD)
The overall goal of MBDD 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.
- Proof of Concept (Phase 2): Data collected at the proof of concept stage can be used to develop ever more robust models. At this stage of development model-based predictions can be critical to selection of study designs, optimal doses, and dosing regimens to progress into Phase III.
- Phase 3 / Late Phase: At this stage in development pharmacokinetic and pharmacodynamic data are typically collected in a broad sample of the target population. These data allow further development of PK and PD models in preparation for regulatory filing and marketing. A key aspect of this stage of MBDD is the characterization of the variability in drug concentrations and drug response.Identification of clinically relevant demographic factors (e.g., age, body weight, renal function, hepatic function) impacting variability is often a critical step in development of these models. Information gleaned from these models often serves as a foundation for developing dosing guidance in special populations (renal/hepatic impairment), age groups (elderly/children) or based on other clinically relevant factors identified in the model.