Pharmacokinetic Support

PPD provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support of Phase I-IV clinical trials. PPD offers 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:

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
ANDA bioequivalence (BE) project management
Design and analysis of PK studies, with emphasis on in vivo/in vitro correlations
PK training for clinical project teams and specialized training for CRAs in critical PK blood sampling procedures and presentation of PK/PD objectives at clinical investigator meetings

Analysis and Interpretation of PK and PK/PD data
Our clinical pharmacology group is skilled and experienced in the analysis and interpretation of PK/PD data, providing assessment of clinical relevance and insight into results for use in your drug development decisions. We perform the following PK 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
Average population and individual bioavailability (BA) and bioequivalence (BE) assessments
Review of all PK parameters and concentration-vs.-time profiles
Evaluation of linear and nonlinear pharmacokinetics
Population pharmacokinetics

Bioanalytical and Statistical Assessments
PPD helps you assess bioanalytical and biomarker methods and validations, conducts expert review of bioanalytical data for aberrant values requiring repeat analyses, and provides pharmacokinetic evaluation of aberrant plasma concentrations affecting study interpretation. In addition, we perform statistical assessments of PK, PD and in vitro data and can develop, review and approve the PK and PD marker sections of your statistical analysis plan.

Population PK Analysis for Optimum Dosing
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

PPD statisticians and pharmacokineticists are experienced in the use of the modeling software NonMEM. Use of this non-linear mixed effect modeling enables interpretation of individual pharmacokinetic data that may be sparse, unbalanced and fragmented in nature. This data may or may not be combined with conventional pharmacokinetic data from traditional studies 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.

24-To 48-Hour Turnaround For Selected Analyses
With expedited PK and statistical analyses, PPD provides preliminary PK results within 24 to 48 hours of data receipt. Expedited analysis is available for:

First-in-man studies
Dose escalation studies requiring linearity assessments between cohorts
Interim PK analysis for NDA and ANDA bioequivalence studies