Clinical Pharmacology

Wide Range of Clinical Pharmacology Support:

  • Clinical Pharmacology Gap Analyses

  • Clinical Pharmacology Development Plan

  • Human Dose Projections & translational modeling

  • First-in-human/patient study design and dose escalation strategy

  • Phase 1/2/3 study support

  • Clinical Pharmacology Representative for Study and Project Team

  • Regulatory Support

  • Due diligence for licensing/investor support

  • Interpretation and application of PK results and modelling analyses

  • Dose selection and justification

  • cQT, TQT and QT waiver support

  • Clinical Pharmacology Study support including:

    • Drug interactions

    • Food Effect

    • Organ Dysfunction

    • Human AME

    • Formulation BA and/or BE

    • Ethnic bridging

  • Pediatric strategy

  • PK study analysis and reporting

  • Module 2.7.1/2.7.2 strategy and writing

  • Clinical Pharmacology writing (protocols, clinical study report, investigator brochures, publications etc)

  • Dose Optimisation (eg. FDA Project Optimus for Oncology drugs)