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).