Pharmacokinetic and Pharmacodynamic Services
PPD provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support of Phase I-IV clinical trials. We offer clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service, with clinical, scientific and regulatory experience in a variety of areas.
Clinical Pharmacology Program and Protocol Development and Support
PPD pharmacokineticists design and conduct Phase I clinical pharmacology protocols, customized to company- specific drugs and therapeutic targets. Experience with regulatory requirements ensures that planned studies are necessary and will result in expeditious review of submissions. PPD provides clinical pharmacology expertise in:
- Clinical PK program development
- Generic drug development
- Transdermal drug delivery
- Design and analysis of PK studies
- Early trials in humans (single and multiple dose)
- Bioequivalence (BE), bioavailability (BA) and DDI trials
- Absorption, distribution, metabolism and elimination (ADME) trials
- Thorough QT (TQT) studies
- Special populations (e.g., patients who suffer from hepatic or renal impairment or, pediatric patients, etc.)
- PK/PD modeling and simulations
Analysis and Interpretation of PK and PK/PD data
Our clinical pharmacology group is skilled and experienced in the analysis and interpretation of pharmacokinetic/pharmacodynamic data, providing assessment of clinical relevance and insight into results for use in your drug development decisions. We perform the following pharmacokinetic services:
- Compartmental and noncompartmental PK analysis and modeling
- PK/PD modeling, useful in proving the therapeutic value of a new pharmaceutical versus similar marketed drugs
- In vivo/in vitro correlations
- BA and BE assessments
- Review of all PK parameters and concentration-versus.-time profiles
- Evaluation of linear and nonlinear pharmacokinetics
Population Pharmacokinetic Analysis
Population pharmacokinetics can play an instrumental role in drug development and is particularly appropriate for:
- Drug labeling, where integration of population PK studies into clinical studies provides useful safety, efficacy and dosage optimization information
- Confirmation of previous pharmacokinetic findings based on small patient populations
Use of non-linear mixed effect modeling enables interpretation of individual pharmacokinetic data that may be sparse, unbalanced and fragmented in nature. This data may be combined with conventional pharmacokinetic data from traditional studies that employing extensive sampling designs.
PPD works in close collaboration with you to ensure that analyses meet individual study objectives. Resulting reports comply with all regulatory requirements and are designed for ease of incorporation into your company's clinical reports.
PPD provides select analyses within 24 to 48 hours.
