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Deficiencies in Bioequivalence dossiers

Deficiencies in Bioequivalence dossiers. Overview and Examples . Summary of Submissions for Tuberculosis-Drugs. 2- FDC (R, H) 29 Pyrazinamide (Z) 19 Ethambutol (E) 18 Isoniazid (H) 16 4-FDC (R,H,Z,E) 13 Rifampicin (R) 12 3-FDC 8.

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467 views • 21 slides

Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO Accra, 5.

Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities. Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO

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297 views • 14 slides

Note on Choice of Comparator Products: Current status

Note on Choice of Comparator Products: Current status. Note to Applicants on Choice of Comparator Products in the Prequalification Project: First draft (Jan. 2005) was circulated among experienced assessors from several countries Now published on the WHO website . Note on Choice of Comparator.

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309 views • 13 slides

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Individual products co - PowerPoint PPT Presentation

Deficiencies in Bioequivalence dossiers

Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO Accra, 5.

Note on Choice of Comparator Products: Current status