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
Get answers to questions about drug discovery and development.