Pharmacokinetics (PK) characterizes the movement of a drug through the body, with parameters describing its absorption, distribution, bioavailability, metabolism, and excretion over time. Pharmacodynamics (PD) characterizes the body’s response to the drug and is often described by biochemical or molecular interactions or physiological effects of a drug. Understanding the exposure-response relationship (PK/PD) is key to the development and approval of every drug.
PK and PD data contribute to much of what is on a drug package insert, and strategic planning of the overall program for a drug and the individual studies can speed the development process.
PK and PD analyses are used to:
- Characterize drug exposure
- Predict dosage requirements
- Assess changes in dosage requirements
- Estimate rate of elimination and rate of absorption
- Assess relative bioavailability / bioequivalence
- Characterize intra- and inter-subject variability
- Understand concentration-effect relationships
- Establish safety margins and efficacy characteristics
We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic principals and making them understandable and usable for common sense drug development. Our highly experienced Pharmacokinetics consultants, many with 15-30 years of experience, conduct analyses in a fully validated computing environment with the latest PK modeling software.
Our Pharmacokinetics / Pharmacodynamics (PK/PD) Services:
- PK/PD analysis and reporting
- Noncompartmental analyses (GLP and Non-GLP)
- Modeling and simulation (compartmental and population PK models)
- Preclinical ADME and human studies
- Dosing simulations
- Risk analysis
- Integrated clinical/PK study reports or standalone PK reports
- Data management services
- CDISC dataset generation
Nuventra can provide noncompartmental clinical PK analysis with turn-around-times as fast as 24 hours. Reporting options range from simple outputs in SAS Transport Files, Microsoft Word & Excel to robust submission-ready reports. We will work with you to determine the most appropriate and cost-effective option for your particular program.