PHARMACEUTICALS USE CASE

For a leader in BIOPHARMACEUTICS

Biopharmaceutics use case

R E Q U I R E M E N T

HELP the biopharmaceutics company in its analytical processes by providing support in the methodology & realization of R&D and industrial statistic studies on various projects

S E R V I C E S  P R O V I D E D

  • DRAFT protocols, DoE (Design of Experiment) and SAP (Statistical Analysis Plan) for industrial statistic studies (comparability studies, capability studies, etc.)
  • PERFORM statistical analysis through tolerance & prediction intervals calculations, statistical inference tests and equivalence tests
  • DEVELOP control charts, trend analysis
  • PARTICIPATE in troubleshooting
  • WRITE statistical reports

D E L I V E R A B L E S  &  B E N E F I T S

TECHNICAL & METHODOLOGICAL SUPPORT on analytical topics

STATISTICAL REPORTS

FUNCTIONAL ANALYSIS REPORTS

Requirement

HELP the biopharmaceutics company in its analytical processes by providing support in the methodology & realization of R&D and industrial statistic studies on various projects

Services provided

  • DRAFT protocols, DoE (Design of Experiment) and SAP (Statistical Analysis Plan) for industrial statistic studies (comparability studies, capability studies, etc.)
  • PERFORM statistical analysis through tolerance & prediction intervals calculations, statistical inference tests and equivalence tests
  • DEVELOP control charts, trend analysis
  • PARTICIPATE in troubleshooting
  • WRITE statistical reports

Deliverables  & benefits

TECHNICAL & METHODOLOGICAL SUPPORT on analytical topics

STATISTICAL REPORTS

FUNCTIONAL ANALYSIS REPORTS

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    Biotechnology use case

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