Part of US based
Semler Group of Companies,
in business since 1946


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Pharmacokinetics & Pharmacodynamics

Semler Research Center (SRC) offers pharmacokinetic (PK) and pharmacodynamic (PD) services to describe the time course of individual exposure and response to a new treatment. Studies are conducted to establish therapeutic schedules, evaluate their relevance, or evaluate dose adjustments in particular patients. Our capabilities in PK include early exploratory, investigative or screening studies, which support regulatory submissions.

Our Pharmacokineticists work closely with our statistical, scientific writing and bioanalytical staff at every stage of the study. From initiation to completion and reporting, they ensure a smooth and effective transition of high-quality pharmacokinetic data from our bioanalytical laboratory to the pharmacokinetics department and then to our statistical and medical writing groups and finally in the preparation of comprehensive ICH compliant reports.

PK and PD in Patients

SRC offers a complete range of research services in the area of pharmacokinetic and ADME studies for small molecules, large molecules, biologics and other related test articles and devices. The studies are conducted to establish therapeutic schedules, to evaluate their relevance or for dose adjustments in particular patients.

Key PK & PD Offerings

  • Input into study design, including pre-clinical-to-clinical considerations (allometric scaling) utilizing information from pre-clinical toxico-kinetic studies
  • Non-compartmental pharmacokinetics
  • Compartmental pharmacokinetics/simulations
  • Ascending dose (assessment of dose proportionality)
  • Repeat dose (assessment of steady-state kinetics and multiple dose linearity)
  • Bioavailability and bioequivalence
  • Drug interaction studies
  • Special population studies
  • Pharmacodynamic and PK/PD modeling
  • Deconvolution
  • Comprehensive text interpretation of data