Introduction into the workshop

Drs. Jan Welink

Training workshop: Training of BE assessors, Kiev, October 2009

Training workshop: Training of BE assessors, Kiev, October 20092 |

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Two assessment forms:

Example of assessment report BE study

Example of a template for assessment of a BE study

retrieved from EU template

Training workshop: Training of BE assessors, Kiev, October 20093 |

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Use of template:

to be filled in by assessors/regulator

differs from WHO template!!

Training workshop: Training of BE assessors, Kiev, October 20094 |

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Clinical study reports:

GCP aspects– audits, inspections, known CRO

Biowaiver– for which strengths, which information submitted,

acceptability

Training workshop: Training of BE assessors, Kiev, October 20095 |

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Pharmacokinetic studies:

Study design

IEC approval

Study dates BE study and analysis

CRO/study centres

Training workshop: Training of BE assessors, Kiev, October 20096 |

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Test and Reference product:

Test (biobatch) product:– manufacturer, manufacturing date, expire date– batch size, potency

Reference product:– MAH, origin– batch number, expire date, potency

Training workshop: Training of BE assessors, Kiev, October 20097 |

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Study population:

Demographic data

Number included

Number excluded

Training workshop: Training of BE assessors, Kiev, October 20098 |

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Analytical methods: Validation– short description– calibration curve range/LoQ– accuracy and precision values– stability data

Analysis subject samples– precision and accuracy– reanalysis– storage period– chromatograms

Training workshop: Training of BE assessors, Kiev, October 20099 |

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Pharmacokinetic variables:

short method description

Statistical method:

short description

factors included

declaration of bioequivalence

Training workshop: Training of BE assessors, Kiev, October 200910 |

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Results:PK data (mean/sd)

– pre-dose values– extent of absorption (>80%)– Cmax in first sampling point??– mean C-t curve

Statistical outcome– Geometric means, ratio, 90% CI– ANOVA CV%

Conclusion: Objections/concerns

Training workshop: Training of BE assessors, Kiev, October 200911 |

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