Clinical PK and PK/PD Data Analysis

CRC have highly skilled and experienced clinical pharmacology group for the analysis, modeling and interpretation of PK/PD data. We also provide assessment of clinical relevance and insight into results for use in drug research and development decisions for clients. Our experts bring the experience of drug labeling, integration of populations PK/PD studies into clinical studies to obtain useful safety, efficacy and dosage optimization information to impact drug labeling.

Key service are :

  • Expert PK input to preclinical and clinical development plans
  • Study design with sample size calculation, optimized sampling schedule
  • Derive PK parameters using Phoenix®, WinNonlin® / R as a standalone service
  • Non-compartmental PK/PD analyses
  • Compartmental PK and PK/PD modeling
  • Population PK/PD modeling
  • Standard Bioequivalence (BE) and Bioavailability(BA) assessment (including food effect)
  • Drug-Drug Interaction (DDI) assessment
  • PK/PD Analysis – modeling the relationship between exposure and response using nonlinear models and nonlinear mixed effect modeling.
  • Toxicokinetic Data Analysis – For GLP toxicology studies, we perform model
  • independent (non-compartmental) analysis to establish exposure, accumulation, and linearity of absorption

Consulting

Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your PK/PD focused programs. CRC Pharma can help design appropriate pharmacokinetic studies, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.