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SPhinCS

Solutions in Pharmacological Investigations - Consulting Services


Statistics and Pharmacokinetics in Clinical Studies

offered by experienced experts for (non-)compartmental PK, population PK and PK/PD

  • PK(/PD) solutions for:
    • Study planning according to developmental stage including pharmacodynamics (PD) PK protocols incl. sample size estimates
    • Data monitoring
    • PK (re-)calculations (SAS, Phoenix WinNonlin)
    • PK & PK/PD modeling, population PK
    • PK interpretation and reports, PK publications
    • PK publications
    • Expert reports for submission of PK & PK/PD data for authorities
  • Any drug candidate:
    • Drug entity:
      • Biologic
      • Biosimilar
      • New chemical entity (NCE)
      • Generic
      • Food supplement
      • Herbal drug
    • Dosing form:
      • Intra-vascular (injection/infusion)
      • Systemic (i.m./s.c./p.o./transdermal system, TDS)
      • Local application
  • Using any specific problem:
    • Bioavailability (LADME) incl. microdosing/tracer
    • Bioeqivalence/Biosimilar
    • PK & PK/PD modelling
    • Special consideration of pharmacogenetics (PG) or other reasons for non-linearity
  • Employing a network of other experts for specialties such as:
    • Interpretation of in-vitro or non-clinical PK data
    • Selection of analytical sites or an appropriate CRO
    • Scientific advice meetings with authorities (local, EMA or FDA)

Your partners:
PD Dr. Karl Ludwig Rost, clinical pharmacologist, >25 years of PK experience
Peter Jaehnig, biostatistician, >25 years of experience in biostatistics


Other experts as required for reliable PK performance (CRO/academic) or regulatory issues may be integrated