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Clinical Study Report

Clinical Study Report. Sita Iyer. What is Report. It is a document that summarizes all the incidences and facts that occurred at a given point of time, places or situation. Guidelines. E3 CTD Canadian USFDA Requirement TGA. Summary of these guidelines.

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5.7k views • 44 slides

Presentation of BE data in a product dossier

Presentation of BE data in a product dossier. Drs. Jan Welink. Training workshop: Training of BE assessors, Kiev, October 2009. Data in a bioequivalence dossier. Data in a bioequivalence dossier. Ethics:. Independent Ethics committee Ethical conduct of study Subject information and consent.

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299 views • 13 slides

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Safety variables - PowerPoint PPT Presentation

Clinical Study Report

Presentation of BE data in a product dossier