Preclinical and Clinical Consulting

ProPharma Services supports and partners with small to mid-sized biotechnology/pharmaceutical companies.  Our expertise can assist in preclinical as well as clinical stages of drug development.  We have broad experience in both small and large molecule drugs including:
- Small molecule metabolism (ADME, CYP reaction phenotyping, induction, extrapolation of in vitro/in vivo data to projected human pharmacokinetics)
- Pharmacokinetics/toxicokinetics (PK/PD and pharmacokinetic modeling)
- Extensive experience with small molecule drug-drug interactions
- Assessment of compound liabilities both in the context of drug discovery/development, and in-licensing opportunities
- Seasoned writers of project reports, IND/NDA enabling documents and IND/CTD/NDA submission
- Experience with all facets of large molecule discovery/development
  • Immune mediated clearance (clearing, neutralizing and sustaining antibodies) and effects on PK and PD
  • Receptor mediated clearance and nonlinearity
  • Immunoassays – cross reactivity, interference from binding proteins
  • Assays for anti-drug antibodies
  • Use of surrogate molecules

Pharmacokinetic Analysis

We have experience modeling PK and PD for large and small molecules.

Population Pharmacokinetics

Our team has expertise in population pharmacokinetics and simulation.

Report Writing

Proficient writers of clinical and preclinical documents.