Bridging the Gap between Preclinical
and Clinical Studies with PKSS

Science, Support and Consultancy for Pharma & Biotech

PKSS supports you in the development of your drug candidates from discovery/preclinical to the initiation of the early clinical phase.

Non-clinical Expertise

  • Drug design-Candidate selection.
  • Non-clinical in vivo DMPK (ADME & QWBA).
  • NCA analysis for PK and TK data.
  • PK/PD studies (exposure- response).
  • ADME models.
  • Selection of appropriate CRO.

general Expertise

  • Interpretation of preclinical & early human data as a guide for next step.
  • Skin PK methods including cutaneous microdialysis (in-vitro, in-vivo, formulation assessment & skin penetration…)
  • Scientific assessment of external opportunities and asset evaluation.
  • In agreement with regulatory guidances

clinical Expertise

  • Support to First in human studies for dose/exposure (NOAEL / MABEL, prediction using allometric scaling)
  • Support to phase 1/POC clinical PK studies.
  • Study design and Protocol.
  • Summary PK analysis & report.
  • Selection of appropriate CRO for phase 1 unit, bioanalysis, modeling and simulations (PK/PD, PBPK).