Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Tanzania, 21-25 August
2006 Dr. Barbara Sterzik, BfArM, Bonn 3
Dossier requirements
general
4. Finished product
4.1 Formulation
4.2 Sites of manufacture
4.3 Manufacturing procedure
4.4 Specifications for excipients
4.5 Specifications for finished product
4.6 Container/closure system(s) and
other packaging
5. Interchangeability
5.1 Bioequivalence study
5.2 Summary of
pharmacology,
toxicology* and efficacy of the
product (expert
reports)
* not required anymore for
Tanzania, 21-25 August
artemisinines but for
2006 Dr. Barbara Sterzik, BfArM, Bonn 6
Basic guidelines
In vivo Bioequivalence studies
are clinical trials:
in accordance with the guidelines
on
Good Clinical Practice
1. Ethical principles :
current version of the Declaration of
Helsinki
Ethic Committee (EC) should be
independent
Information about the EC e.g.
members
constitution of
meetings
discussions, recommendations,
Tanzania, 21-25 August
2006 Dr. Barbara Sterzik, BfArM, Bonn 10
Bioequivalence study report
3. Selection of Investigators
Expertise, qualifications, competence
►Consequence: as there is no
acceptable reference available,
additionally clinical studies on
efficacy and safety are necessary.
Tanzania, 21-25 August
2006 Dr. Barbara Sterzik, BfArM, Bonn 19
Bioequivalence dossier requirements
SPC and PIL
EU – Guidelines
- A guideline on Summary of Product
Characteristics
- Notice to applicants; Rev0, December 1999)