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SERVICES 

Biopharmaceutics & Clinical Pharmacokinetics

 

  • Development of Clinical Study Concepts for e.g.:

    • single dose pharmacokinetics (PK)

    • multiple dose PK

    • first-in-human ascending dose studies

    • absolute and relative bioavailability studies

    • mass balance studies

  • Non-Compartmental Analysis of PK results

  • Compartmental Analysis (CA) of PK results

  • Bioequivalence analysis

  • Steady state simulation based on CA

  • IVIVC

  • Quality control

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ClinPharm Services uses Certara Phoenix WinNonLin 8.3, a nonlinear modelling tool suitable for PK/PD modeling and non-compartmental analysis, to evaluate bioavailability and clinical pharmacokinetic studies (for exploratory purposes, only). 

Medical Writing

 

  • Literature overviews & reviews

  • Biowaivers

  • Clinical study protocols

  • Informed consent forms

  • Clinical study reports

  • Investigator brochures

  • Writing of biopharmaceutics and clinical pharmacology parts of filing dossiers according to the Common Technical Document

  • Manuscripts and abstracts

  • Expert reports

  • PK position papers

  • Briefing books

  • CSR review and quality control

  • Evaluation of ethnic factors (ICH-E5)

Regulatory Affairs
 
  • Response to queries from Regulatory Agencies
  • Briefing books for Scientific Advice
  • Review of filing documents
  • Summary of biopharmaceutics studies and associated analytical methods
  • Summary of clinical pharmacology studies
  • Clinical overview
  • Tabulated summaries
  • Quality control
Other, not exclusive

 

  • Development of Clinical Study Concepts for medical device testing, e.g.:

    • irritation testing

    • performance testing

  • Writing and review of Standard Operating Procedures and Work Instructions

  • Providing for basic WinNonLin training on base of self-developed training manual

  • Development of presentations for PK training

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