SERVICES
Biopharmaceutics & Clinical Pharmacokinetics
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Development of Clinical Study Concepts for e.g.:
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single dose pharmacokinetics (PK)
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multiple dose PK
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first-in-human ascending dose studies
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absolute and relative bioavailability studies
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mass balance studies
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Non-Compartmental Analysis of PK results
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Compartmental Analysis (CA) of PK results
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Bioequivalence analysis
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Steady state simulation based on CA
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IVIVC
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Quality control
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
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Literature overviews & reviews
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Biowaivers
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Clinical study protocols
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Informed consent forms
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Clinical study reports
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Investigator brochures
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Writing of biopharmaceutics and clinical pharmacology parts of filing dossiers according to the Common Technical Document
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Manuscripts and abstracts
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Expert reports
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PK position papers
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Briefing books
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CSR review and quality control
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Evaluation of ethnic factors (ICH-E5)
Regulatory Affairs
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Response to queries from Regulatory Agencies
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Briefing books for Scientific Advice
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Review of filing documents
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Summary of biopharmaceutics studies and associated analytical methods
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Summary of clinical pharmacology studies
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Clinical overview
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Tabulated summaries
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Quality control
Other, not exclusive
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Development of Clinical Study Concepts for medical device testing, e.g.:
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irritation testing
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performance testing
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Writing and review of Standard Operating Procedures and Work Instructions
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Providing for basic WinNonLin training on base of self-developed training manual
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Development of presentations for PK training